Their Lordships, having taken these Rules into consideration, are pleased to and do approve them.

This Order may be cited as the General Pharmaceutical Council (Registration Rules) Order of Council 2010 and comes into force on 27th September 2010.

SCHEDULEThe General Pharmaceutical Council (Registration) Rules 2010

The General Pharmaceutical Council, in exercise of the powers conferred by sections 74A(6) and (7), 74B(2), 74C(4), 74E(2), 74G(2) and 74I(3) of the Medicines Act 1968(4) and articles 19(3) and (4), 23(1), 25(3), 27(1), 28(1), 29(4), 30(2) and (4), 31(1), 36(1) and (3), 37(3) and 66(1) of the Pharmacy Order 2010(5), makes the following Rules:

PART 1General

Citation and commencement

1.-(1) These Rules may be cited as the General Pharmaceutical Council (Registration) Rules 2010 and, except as provided for by paragraph (2), come into force on 27th September 2010.

(2) Rules 11, 13, 24 and 26 of these Rules come into force on 4th January 2011.

Interpretation

2. In these Rules-

"the Act" means the Medicines Act 1968;

"the Order" means the Pharmacy Order 2010;

"Fitness to Practise Rules" means the General Pharmaceutical Council (Fitness to Practise and Disqualification etc.) Rules(6);

"health care professional" means an individual registered with a health care regulatory body;

"legal professional" means a person who is legally qualified within the meaning of rule 2 of the General Pharmaceutical Council (Statutory Committees and their Advisers) Rules 2010(7);

"made on line", in relation to an application under Part 3 or 5 of these Rules, means submitted to the Registrar in electronic format via the internet;

"prescribed fee" means any fee prescribed in rules made by the Council under article 36 of the Order;

"representative" means a representative within the meaning given in section 72(4) of the Act(8) (representative of pharmacist in case of death or disability); and

"responsible pharmacist" has the meaning given in section 72A of the Act(9) (the responsible pharmacist).

Service of documents

3.-(1) Subject to paragraph (2), any notice, demand or document required to be served by the Registrar must be in writing and must be served by sending it by a postal service or another delivery service (including, with the agreement of the person concerned, by electronic mail to an electronic mail address notified to the Registrar as an address for communications) or by leaving it at-

(a)in the case of a registrant, at the registrant's home address in the Register;

(b)in the case of a person who is not a registrant, to that person at that person's last known home address; or

(c)in the case of a person carrying on a retail pharmacy business at a registered pharmacy-

(i)where that person is an individual, to that individual's home address in the Register,

(ii)where that person is a partnership, to the principal office of that partnership, or

(iii)where that person is a body corporate, to the registered or principal address of that body corporate.

(2) If a person on whom any notice, demand or document is to be served by the Registrar so requests, such a notice, demand or document may be sent to or left at-

(a)where that person is represented by a solicitor, the solicitor's practising or electronic mail address; or

(b)where that person is represented by a defence organisation or trade union, the business or electronic mail address for that defence organisation or trade union.

(3) Where a notice, demand or document is sent by post, unless sent by a postal service which records the date of delivery, it must be sent by first class post and is to be treated as having been served on the day after the day on which it was posted.

(4) Where a notice, demand or document has been sent by electronic mail or left at an address, it is to be treated as having been served on the day on which it was sent by electronic mail or left at that address.

Fees

4.-(1) The Registrar may decide, at the Registrar's discretion-

(a)not to charge a prescribed fee in connection with an application under Part 3 or 5 of these Rules; or

(b)to waive a prescribed fee in connection with such an application either in whole or in part.

(2) The Registrar may offer to any person who makes an application under Part 3 or 5 of these Rules ("the applicant") the option of paying a prescribed fee in connection with the application by way of direct debit in instalments or otherwise and the payment by direct debit of any such fee is to be subject to such terms and conditions as are agreed between the Registrar and the applicant.

PART 2The Register

The keeping of the Register

5.-(1) The Register is to be kept and maintained-

(a)in writing; and

(b)securely, in a manner which guards against falsification.

(2) The Registrar is responsible for ensuring that an entry appears in the Register in respect of each person who or, in the case of a registered pharmacy, premises which-

(i)is or are newly entered in, or newly restored to, the Register, or

(ii)has or have had an entry in the Register renewed.

(3) Before making alterations to any of the particulars of a registrant's entry in the Register or, as the case may be, of an entry of a registered pharmacy in the Register, the Registrar must be satisfied as to the accuracy of any new information to be recorded in the Register and may-

(a)in the case of a registrant, require the registrant to produce a statutory declaration, a marriage certificate or such other documentary evidence as the Registrar may consider appropriate in any case; or

(b)in the case of a registered pharmacy, require the person carrying on a retail pharmacy business at the registered pharmacy to provide such documentary evidence as the Registrar may reasonably request.

(4) Where the Investigating Committee-

(a)issues a warning to a registrant; or

(b)agrees undertakings with a registrant that relate to the registrant's fitness to practise,

the Registrar must ensure that an appropriate alteration to that registrant's entry in the Register is made to record that warning or undertaking.

(5) Where the Fitness to Practise Committee-

(a)issues a warning to a registrant;

(b)agrees undertakings with a registrant that relate to the registrant's fitness to practise;

(c)gives a direction that a registrant's entry in the Register be suspended (including a direction imposing an interim suspension order), or gives a direction amending that direction; or

(d)gives a direction that a registrant's entry in the Register be conditional upon the registrant complying with specified requirements (including a direction imposing an order for interim conditional entry), or gives a direction amending that direction,

the Registrar must ensure that an appropriate alteration is made to that registrant's entry in the Register to record that warning, undertaking, direction or amending direction (in the case of a direction, once that direction has taken effect).

(6) Where, in the case of a registrant, the Fitness to Practise Committee determines that the registrant's fitness to practise is impaired, the Registrar must ensure that an appropriate alteration is made to that registrant's entry in the Register to record the determination.

(7) Where the Fitness to Practise Committee gives a direction that the entry of a registrant in the Register, or a part of the Register, be removed from the Register, or from part of the Register, the Registrar must ensure that an appropriate alteration is made to the Register removing the entry of that registrant from the Register, or from the relevant part of the Register, (once the direction has taken effect).

(8) Where, in proceedings under section 80 of the Act(10) (power for relevant disciplinary committee to disqualify and direct removal from the Register), the Fitness to Practise Committee-

(a)directs-

(i)that a body corporate is to be disqualified for the purposes of Part 4 of the Act, and

(ii)the Registrar to remove all premises entered in Part 3 of the Register that are premises at which that body corporate carries on a retail pharmacy business; or

(b)directs the Registrar to remove from Part 3 of the Register all premises at which a body corporate carries on a retail pharmacy business, or such of them as may be specified in the direction,

the Registrar must ensure that an appropriate alteration is made to Part 3 of the Register removing from that part of the Register the entry relating to each of the premises to which the direction relates (once the direction has taken effect).

Content of the Register: registrants

6.-(1) The Register must, in respect of each registrant who is entered in it, contain the following information-

(a)the registrant's title;

(b)the name under which the registrant practises or intends to practise (the registrant's "registered name");

(c)any previous names under which the registrant has practised;

(d)the registrant's home address (the registrant's "registered address");

(e)the number of the registrant's entry in the Register;

(f)the date of the first, and any subsequent, entry of the registrant in the Register;

(g)the period for which the entry of the registrant in the Register is valid;

(h)any annotations in respect of specialisations made to the registrant's entry in the Register;

(i)any qualifications by reference to which the Registrar is satisfied that the registrant is appropriately qualified within the meaning of articles 21(1) and 22(1) of the Order; and

(j)the date of the last review of the registrant's continuing professional development record.

(2) The Registrar must make provision for-

(a)recording the information referred to in paragraph (1)(a) to (j) in the Welsh language where appropriate; and

(b)marking the Register so as to distinguish those registrants who are entered in Part 1 or, as the case may be, Part 2 of the Register by virtue of article 34 of the Order (temporary entry with regard to emergencies involving loss of human life or human illness etc.) from the entries in those parts of the Register in respect of other registrants.

(3) Except as provided for by paragraph (4), the Registrar may disclose any of the information referred to in paragraph (1) that does not appear in the lists published by the Council under article 19(7) of the Order to any person if the Registrar considers it to be in the public interest to do so.

(4) The Registrar may not disclose a registrant's registered address in any list published by the Council under article 19(7) of the Order.

(5) The Registrar must only record a title to be included in the Register by virtue of paragraph (1)(a) (other than Mr, Mrs, Miss or Ms) where the Registrar is satisfied as to the authenticity of the title claimed.

Content of the Register: registered pharmacies

7.-(1) The Register must, in respect of any premises entered in Part 3 of the Register, contain the following information-

(a)the address of the premises;

(b)the name and address of the person carrying on a retail pharmacy business at the premises;

(c)the name under which the business carried on at the premises trades;

(d)the number of the entry of the premises entered in the Register;

(e)the date of the first, and any subsequent, entry of the premises entered in the Register;

(f)the period for which the entry of the premises entered in the Register is valid;

(g)any conditions to which the entry of the premises entered in the Register is subject;

(h)any annotations in respect of specialisations made to the entry of the premises entered in the Register;

(i)where the business is carried on at the premises by a body corporate, the name and home address of the superintendent pharmacist; and

(j)details of any improvement notices issued under article 13 of the Order in respect of the carrying on of a retail pharmacy business at the premises entered in the Register.

(2) For the purposes of paragraph (1)(b), the address to be included in the Register is-

(a)where the business is carried on at the premises by an individual, that individual's home address in the Register;

(b)where the business is carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the business is carried on at the premises by a body corporate, the registered or principal address of that body corporate.

(3) The Registrar must make provision for-

(a)recording the information referred to in paragraph (1)(a) to (j) in the Welsh language where appropriate; and

(b)marking the Register so as to distinguish those premises which are entered in Part 3 of the Register by virtue of section 74J of the Act (temporary entry with regard to emergencies involving loss of human life or human illness etc.) from the entries in that part of the Register in respect of other premises.

(4) Except as provided for by paragraph (5), the Registrar may disclose any of the information referred to in paragraph (1) that does not appear in the lists published by the Council under article 19(7) of the Order to any person if the Registrar considers it to be in the public interest to do so.

(5) The Registrar may not disclose the home address of a registrant who is a person carrying on a retail pharmacy business at a registered pharmacy or of the superintendent pharmacist in relation to a registered pharmacy in any list published by the Council under article 19(7) of the Order.

Duty to notify Registrar of changes to information: registrants

8.-(1) A registrant must notify the Registrar of-

(a)any change to the name under which the registrant practises or intends to practise; and

(b)any change to the registrant's home address in the Register or to any of the registrant's contact details as previously notified by the registrant to the Registrar.

(2) For the purposes of paragraph (1), the registrant must give notice to the Registrar of any change of information in writing before the expiry of the period of one month beginning with the date on which the change occurred.

PART 3Applications relating to Parts 1 and 2 of the Register

Applications: general

9. The Council may make such provision as it considers appropriate for applications under this Part to be made on line to the Registrar.

Entry in the Register

10.-(1) Subject to the following paragraphs, applicants for entry in Part 1 or, as the case may be, Part 2 of the Register must apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) The application form must, in particular-

(a)require the applicant to-

(i)provide the applicant's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(ii)specify-

(aa)the part of the Register in which entry is sought,

(bb)whether the applicant has previously been entered in the Register, or part of the Register,

(iii)declare that the applicant-

(aa)agrees, upon entry to the Register, to adhere to any standards set by the Council under article 43(1)(b) of the Order relating to the continuing professional development that it is necessary for a registrant to maintain in order to have an entry in Part 1 or, as the case may be, Part 2 of the Register renewed,

(bb)agrees, upon entry in the Register, to adhere to any standards set by the Council under article 48(1)(a) of the Order relating to the conduct, ethics and performance expected of registrants, and

(cc)understands that, in the event that the applicant is found to have given false or misleading information in connection with the application, the applicant's entry in the Register may be removed from the Register,

(iv)provide the necessary supporting documents referred to in paragraph (3),

(v)sign and date the application, and

(vi)in the case of any person who is appropriately qualified as a pharmacist within the meaning of article 21(1)(a) of the Order or, as the case may be, as a pharmacy technician within the meaning of article 22(1)(a) of the Order, have the form countersigned and dated by another person who is a pharmacist entered in Part 1 of the Register or a pharmacy technician entered in Part 2 of the Register; and

(b)include a demand that the applicant pay the prescribed fees in respect of the application.

(3) An applicant for entry in Part 1 or 2 of the Register must provide to the Registrar, together with the applicant's application form-

(a)evidence of the applicant's identity in the form of-

(i)the applicant's passport (or a true copy of it certified by a notary or solicitor) or another document which is considered acceptable by the Registrar as proof of the applicant's identity, and

(ii)a photograph which is signed and dated by a legal or health care professional, justice of the peace or person of standing in the community who has known the applicant for at least two years and who certifies that the photograph is a true likeness of the applicant;

(b)where the applicant wishes to use a registered name which is different from the name given on the applicant's evidence of identity-

(i)the relevant marriage certificate or certificate of civil partnership (or a true copy of it certified by a notary or solicitor),

(ii)the relevant certificate of change of name (or a true copy of it certified by a notary or solicitor), or

(iii)evidence of a change of name in the form of a statutory declaration;

(c)evidence of the applicant's date of birth in the form of-

(i)the applicant's passport (or a true copy of it certified by a notary or solicitor) or other document considered acceptable under paragraph (3)(a)(i), and

(ii)either-

(aa)the applicant's birth certificate (or a true copy of it certified by a notary or solicitor), or

(bb)a statutory declaration;

(d)evidence of the applicant's nationality in the form of-

(i)the applicant's passport (or a true copy of it certified by a notary or solicitor), or

(ii)any other documentation that is acceptable to the Registrar;

(e)where the applicant is an exempt person within the meaning of article 3(1) of the Order-

(i)evidence that the applicant is a national of a relevant European State, or

(ii)where the applicant is not a national of a relevant European State, evidence of the Community right by virtue of which the applicant is an exempt person which, in a case where sub-paragraph (f) applies, must be the evidence set out in that sub-paragraph;

(f)if an applicant seeks to rely on rights acquired by virtue of marriage or civil partnership to a national of a relevant European State-

(i)evidence which is sufficient evidence in the opinion of the Registrar of the marriage or civil partnership,

(ii)the passport (or a true copy of it certified by a notary or solicitor) of the spouse or partner who is a national of a relevant European State, and

(iii)an explanation, together with any relevant supporting evidence, as to why the applicant is entitled to be treated as a national of a relevant European State;

(g)evidence that the applicant is appropriately qualified as a pharmacist or a pharmacy technician within the meaning of article 21(1) or, as the case may be, 22(1) of the Order;

(h)if the applicant is an exempt person ("E") who is applying to be entered in Part 1 of the Register, evidence which is sufficient in the opinion of the Registrar to demonstrate that E-

(i)holds a qualification listed in Annex V, point 5.6.2 of the Directive (evidence of formal qualifications of pharmacists), and

(ii)has successfully completed training as a pharmacist that meets, or under article 22(a) of the Directive (part-time training) is to be treated as meeting, the requirements of Article 44 of the Directive (training as a pharmacist),

and E must also provide a certificate which must be issued by a competent authority in E's attesting State and which must certify that the evidence of qualification provided by E is a diploma listed in relation to that State in Annex V, point 5.6.2 of the Directive;

(i)if the applicant is an exempt person ("E") and is an applicant for the purposes of Chapter 1 of Part 3 of the General Systems Regulations-

(i)evidence which, in the opinion of the Registrar, is sufficient evidence of that qualification,

(ii)information about E's knowledge, standards of practice and work experience, wherever acquired, which is sufficient in the opinion of the Registrar to determine whether E should be entered in Part 1 or, as the case may be, Part 2 of the Register or be subject to a compensation measure, within the meaning of regulations 23 and 24 of the General Systems Regulations (compensation measures -� adaptation periods and aptitude tests), and

(iii)if E is subject to such a compensation measure, evidence of its successful completion;

(j)as regards the good physical and mental health of the applicant-

(i)in a case where the applicant is an exempt person ("E")-

(aa)a certificate (which, if it is not in English, the Registrar may require to be translated by a professional translator acceptable to the Registrar), issued by the competent authorities in E's attesting state no more than three months prior to the date on which it is presented to the Registrar, which attests to E's good physical and mental health, and which is sufficient evidence of E's good physical and mental health for the purposes of article 23(5) of the Order,

(bb)if no such certificate is required of such a person in E's attesting State, a certificate (which, if it is not in English, the Registrar may require to be translated by a professional translator acceptable to the Registrar), issued by the competent authorities in E's attesting State no more than three months prior to the date on which it is presented to the Registrar, which confirms, for the purposes of article 23(6) of the Order, that there is no problem with E's physical or mental health that would impair E's fitness to practise as a pharmacist or, as the case may be, a pharmacy technician, or

(ii)in the case of any other applicant (or an applicant who is an exempt person who chooses to attest to their physical and mental health in this way), a self declaration in the form determined by the Council from time to time, of the applicant's good physical and mental health, which is signed and dated by the applicant; and

(k)as regards the good character or repute of the applicant-

(i)in a case where the applicant is an exempt person ("E")-

(aa)a certificate (which, if it is not in English, the Registrar may require to be translated by a professional translator acceptable to the Registrar), issued by the competent authorities in E's attesting State no more than three months prior to the date on which it is presented to the Registrar, which is sufficient evidence of E's good character or repute for the purposes of article 23(7) of the Order, or

(bb)if no such certificate is issued by a competent authority in E's attesting State, a certificate (which, if it is not in English, the Registrar may require to be translated by a professional translator acceptable to the Registrar), issued by a competent judicial or administrative authority, notary or qualified professional body in E's attesting State no more than three months prior to the date on which it is presented to the Registrar, attesting to the authenticity of a declaration on oath or solemn declaration made by E before that authority, notary or body attesting to E's good character for the purposes of article 23(8) of the Order, and

(ii)whether or not the applicant is an exempt person, a self declaration, in the form determined by the Council from time to time, of the applicant's good character or repute which states whether any of the matters set out in article 51(1)(e) to (n) of the Order exist in relation to the applicant and which is signed and dated by the applicant.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) The additional matters referred to in paragraph (4) are-

(a)a completed and signed application form and authorisation for the Registrar to obtain a certificate of enhanced disclosure from the Secretary of State or the Scottish Ministers;

(b)where the applicant has previously obtained a certificate of standard or enhanced disclosure from the Secretary of State or, as the case may be, the Scottish Ministers for the purpose of applying to be entered on a list of performers or providers of pharmaceutical services as part of the health service, that certificate (or a true copy of it certified by a notary or solicitor);

(c)where the applicant has been the subject of a determination by a regulatory body that the applicant's fitness to practise is impaired, or a determination to the same effect, details of any investigations, the proceedings and the outcome;

(d)where the applicant is included in a barred list within the meaning of the Safeguarding Vulnerable Groups Act 2006(11) or the Safeguarding Vulnerable Groups (Northern Ireland) Order 2007(12) or is included in the children's or the adults' list within the meaning of the Protection of Vulnerable Groups (Scotland) Act 2007(13), details of that inclusion;

(e)in the case of an applicant who qualified or has practised as a pharmacist or pharmacy technician outside Great Britain, a certificate of good standing or current professional status issued no more than three months prior to the date of the application-

(i)by the appropriate authority of the country in which the applicant qualified, and

(ii)by the appropriate authority of every country in which the applicant has practised within the five years immediately preceding the date of the application; and

(f)in the case of an applicant who obtained a degree in the United Kingdom, confirmation from the university that awarded the degree that nothing adverse is known about the applicant.

(6) For the purposes of paragraph (5)(e) a certificate of good standing or current professional status is a certificate which contains the following information-

(a)the applicant's full name, home address and date of birth;

(b)full details of the applicant's education and qualifications in pharmacy;

(c)full details of the applicant's entry in a register or part of a register maintained by the relevant competent authority or authorities;

(d)full details of any conditions to which the applicant's entry in a register or part of a register is subject and of any restrictions on the applicant's practice;

(e)full details of any fitness to practise matters in relation to the applicant including any warnings or advice given by, or undertakings agreed with, the relevant competent authority or authorities; and

(f)such other relevant information as the Registrar may reasonably request in relation to the applicant in the particular circumstances of the applicant's case.

(7) Where the applicant is a person who has previously been entered in the Register, or part of the Register, the Registrar may dispense with any of the requirements under this rule for the applicant to provide such documents, information or evidence in support of the application as the Registrar may determine in the circumstances of the applicant's case.

(8) Before deciding whether or not an applicant's fitness to practise is impaired for reasons other than adverse physical or mental health, the Registrar may seek the advice of the Fitness to Practise Committee in respect of the application.

(9) In making a decision about the applicant's good character, the Registrar must have regard, as appropriate, to the criteria specified in rule 5 of the Fitness to Practise Rules.

(10) Before deciding whether or not an applicant's fitness to practise is impaired because of adverse physical or mental health, the Registrar may seek the advice of the Fitness to Practise Committee.

(11) The Registrar must refuse an application under this rule if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fees in respect of the application.

(12) For the purposes of this rule, "attesting State" means the relevant European State in which a person applying for entry in Part 1 or Part 2 of the Register obtained their qualification as a pharmacist or, as the case may be, a pharmacy technician and, if different, the relevant European State from which that person comes to Great Britain.

Renewal of an entry in the Register

11.-(1) Subject to the following paragraphs, applicants for the renewal of an entry in Part 1 or, as the case may be, Part 2 of the Register must apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule must be made to the Registrar no later than two months before the date on which the entry in the Register would cease to be valid if not renewed.

(3) The Registrar must send to each registrant the relevant application form for the renewal of an entry in Part 1 or, as the case may be, Part 2 of the Register at least three months before the date on which the registrant's entry in the relevant part of the Register would cease to be valid if not renewed.

(4) The application form must, in particular-

(a)require the registrant to-

(i)provide the registrant's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(ii)provide the number of the entry in Part 1 or, as the case may be, Part 2 of the Register to which the application relates,

(iii)declare that the registrant agrees to adhere to any standards set by the Council under article 43(1)(b) of the Order relating to the continuing professional development that it is necessary for a registrant to maintain in order to have an entry in Part 1 or, as the case may be, Part 2 of the Register renewed,

(iv)declare the registrant's intention to adhere to the standards set by the Council under article 48(1)(a) of the Order relating to the conduct, ethics and performance expected of registrants, and

(v)specify-

(aa)whether any of the matters referred to in article 51(1)(e) to (n) of the Order exist in relation to the registrant which have not previously been notified to the Council, or

(bb)whether, in relation to the registrant, there have been any findings of impairment of the registrant's fitness to practise made by a regulatory body which have not previously been notified to the Council or, prior to 27th September 2010, to the Society;

(b)include a demand that the registrant pay the prescribed fees in respect of the application;

(c)inform the registrant that-

(i)if the declaration included in the application is not completed to the satisfaction of the Registrar, the Registrar may refuse to renew the applicant's entry in Part 1 or, as the case may be, Part 2 of the Register because the application does not comply with the requirements of this rule, and

(ii)in the event that the registrant is found to have given false or misleading information in connection with the application, that may be treated as misconduct for the purposes of article 51(1)(a) of the Order which may result in the removal of the registrant's entry from the relevant part of the Register; and

(d)require the registrant to sign and date the application.

(5) If a registrant has not received an application form for the renewal of the registrant's entry in Part 1 or, as the case may be, Part 2 of the Register by the beginning of the period of three months before the date on which the registrant's entry in the Register would cease to be valid if not renewed, the registrant must notify the Registrar accordingly.

(6) Except as provided for by paragraph (7), the Registrar must refuse an application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if it is not accompanied by the necessary supporting documents, information and evidence as mentioned in the application form; or

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

(7) If there is an ongoing fitness to practise investigation, or there are ongoing fitness to practise proceedings, in respect of a registrant who-

(a)has not made an application for the renewal of their entry in Part 1 or, as the case may be, Part 2 of the Register; or

(b)has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application,

the Registrar may not remove the registrant's entry from the relevant part of the Register in accordance with article 25(3) of the Order except in cases where the Registrar considers that the public interest would be best served by so doing.

Annotations made to an entry in the Register

12.-(1) Subject to the following paragraphs, a registrant entered in Part 1 or, as the case may be, Part 2 of the Register may apply to the Registrar to have an annotation in respect of a specialisation made to the registrant's entry in the relevant part of the Register.

(2) An application under this rule must be made to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(3) The application form must, in particular-

(a)require the applicant to-

(i)provide the applicant's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(ii)specify whether the application relates to an entry in Part 1 or Part 2 of the Register,

(iii)specify the number of the entry in the Register to which the application relates,

(iv)specify the type of specialisation which is to be the subject matter of the annotation,

(v)provide evidence which is sufficient in the opinion of the Registrar to demonstrate that the applicant meets such standards of proficiency for the safe and effective practice of pharmacy as are set in rules under article 27(1)(e) of the Order, and

(vi)provide any other necessary supporting documents, information or evidence as mentioned in the application form;

(b)include a demand that the registrant pay the prescribed fee in respect of the application; and

(c)require the applicant to sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) Where the applicant is a person who has previously had an annotation in respect of a specialisation made to an entry in the Register, or part of the Register, the Registrar may dispense with any of the requirements under this rule for the applicant to provide such documents, information or evidence in support of the application as the Registrar may determine in the circumstances of the applicant's case.

(6) Where the Registrar grants an application under this rule that relates to an entry in Part 1, or as the case may be, Part 2 of the Register, the Registrar must ensure that an appropriate annotation is made to a registrant's entry in that Part of the Register to denote the type of specialisation in respect of which the annotation to that entry is made.

(7) The Registrar may not grant an application under this rule unless the Registrar is satisfied that the applicant meets the standards of proficiency referred to in paragraph (3)(a)(v).

(8) The Registrar must refuse any application under this rule-

(a)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or

(b)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

Renewal of an annotation made to an entry in the Register

13.-(1) Subject to the following paragraphs, applicants for the renewal of an annotation in respect of a specialisation made to an entry in Part 1 or, as the case may be, Part 2 of the Register may apply to the Registrar.

(2) An application under this rule must be made to the Registrar no later than two months before the date on which the entry in the Register to which the annotation relates would cease to be valid if not renewed using the relevant application form which must be in such form as the Council may from time to time determine.

(3) The Registrar must send to each registrant whose entry in Part 1 or, as the case may be, Part 2 of the Register is annotated to denote a specialisation an application form at least three months before the date on which the registrant's entry in the relevant part of the Register would cease to be valid if not renewed.

(4) The application form must, in particular-

(a)include a demand that the registrant pay the prescribed fee in respect of the application; and

(b)require the applicant to-

(i)provide the applicant's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(ii)specify whether the application relates to an entry in Part 1 or Part 2 of the Register,

(iii)specify the number of the entry in the Register to which the application relates,

(iv)provide any other necessary supporting documents, information or evidence as mentioned in the application, and

(v)sign and date the application.

(5) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(6) The Registrar must refuse any application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form; or

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

(7) If a registrant with an annotation in respect of a specialisation made to an entry in Part 1 or, as the case may be, Part 2 of the Register has not received an application form for the renewal of that annotation by the beginning of the period of three months before the date on which the registrant's entry in the Register would cease to be valid if not renewed, the registrant must notify the Registrar accordingly.

Voluntary removal of an entry or annotation from the Register

14.-(1) Subject to the following paragraphs, applicants for the voluntary removal of an entry from Part 1 or, as the case may be, Part 2 of the Register, or the voluntary removal of an annotation in respect of a specialisation made to such an entry, may apply to the Registrar.

(2) An application under this rule must be made to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(3) The application form must, in particular-

(a)require the applicant ("A") to-

(i)specify A's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(ii)indicate whether the application is an application for the voluntary removal of an entry in Part 1 or 2 of the Register or, as the case may be, of an annotation in respect of a specialisation made to such an entry, and

(iii)specify the number of the entry in the Register to which the application relates;

(b)if A is a superintendent pharmacist, require A to state that fact,

(c)require A to-

(i)declare that A is not aware of any investigation by any enforcement or regulatory body, or proceedings brought by such a body, that relate to A's fitness to practise, or of any act or omission on A's part which might render A liable to an allegation being referred to the Council that A's fitness to practise is impaired,

(ii)provide any supporting documents, information or evidence as mentioned in the application form, and

(iii)sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) Upon receipt of an application under this rule, the Registrar must make such inquiries as the Registrar considers necessary in order to be satisfied that there are no ongoing investigations or outstanding proceedings relating to the registrant's fitness to practise.

(6) The Registrar must not grant an application under this rule unless-

(a)the Registrar is satisfied that there are no ongoing investigations or outstanding proceedings relating to the registrant's fitness to practise; or

(b)in cases where there are such investigations or proceedings, the Registrar considers that the public interest would be best served by granting the application.

(7) Where the Registrar grants an application under this rule, the Registrar must make an appropriate alteration to Part 1 or, as the case may be, Part 2 of the Register to remove the entry, or the annotation made to the entry, from the relevant part of the Register and must publish that fact on the Council's website.

Voluntary removal: supplementary provision

15.-(1) Where the Registrar becomes aware that an application for the voluntary removal of an entry from Part 1 or, as the case may be, Part 2 of the Register-

(a)has been granted in reliance upon information provided by the applicant ("the former registrant") relating to fitness to practise matters that was false or misleading; and

(b)but for that information, the application would have been refused by virtue of rule 14(6),

the Registrar must revoke the decision to grant the application and must restore the entry of the former registrant to the relevant part of the Register.

(2) An entry restored to Part 1 or, as the case may be, Part 2 of the Register under paragraph (1)-

(a)is still to be treated as having been entered in that part of the Register; and

(b)is valid for the same period as the period for which the entry would have been valid, or would have been treated as valid, under article 25 of the Order had it not been removed from the Register by virtue of an application under rule 14.

(3) Paragraph (2) does not apply to an entry in Part 1 or, as the case may be, Part 2 of the Register which has ceased to be valid by virtue of article 25(3) of the Order before the Registrar became aware of a matter referred to in paragraph (1)(a) or (b).

Restoration of an entry in the Register

16.-(1) Subject to the following paragraphs, applicants for the restoration of an entry to Part 1 or, as the case may be, Part 2 of the Register may apply to the Registrar.

(2) An application under this rule must be made to the Registrar using the relevant application form, which must be in such form as the Council may from time to time determine, before the end of the period of twelve months beginning with-

(a)the date on which the entry was removed from the relevant part of the Register pursuant to an application for voluntary removal under rule 14; or

(b)the date on which the entry was removed from the relevant part of the Register under or by virtue of a provision specified in article 37(1)(a) to (d) or (f) or (g) of the Order.

(3) The application form may, in particular-

(a)require the applicant ("A") to-

(i)specify-

(aa)the applicant's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(bb)the part of the Register to which the application relates, and

(cc)the number of the entry in the Register to which the application relates,

(ii)declare-

(aa)that A agrees, upon A's entry being restored to the Register, to adhere to any standards set by the Council under article 43(1)(b) of the Order relating to the continuing professional development that it is necessary for a registrant to maintain in order to have an entry in Part 1 or, as the case may be, Part 2 of the Register renewed;

(bb)A's intention to adhere to the standards set by the Council under article 48(1)(a) of the Order relating to the conduct, ethics and performance expected of registrants, and

(cc)that A is not aware of any investigation by any enforcement or regulatory body, or proceedings brought by such a body, that relate to A's fitness to practise, or of any act or omission on A's part that might render A liable to an allegation being referred to the Council that A's fitness to practise is impaired,

(iii)specify-

(aa)whether any of the matters referred to in article 51(1)(e) to (n) of the Order exist in relation to the registrant which have not previously been notified to the Council; or

(bb)whether, in relation to the registrant, there have been any findings of impairment of the registrant's fitness to practise made by a regulatory body which have not previously been notified to the Council or, prior to 27th September 2010, to the Society, and

(iv)provide any necessary supporting documents, information or evidence as mentioned in the application form;

(b)include a demand that the applicant pay the prescribed fees in respect of the application; and

(c)require the applicant to sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) The Registrar must consider-

(a)whether the applicant should be required to undertake any additional education, training or experience before the applicant's entry is restored to the Register; and

(b)whether the applicant should be required to undertake any additional continuing professional development after the applicant's entry is restored to the Register,

and, where necessary, the Registrar may determine the additional education, training or experience or additional continuing professional development that it is appropriate for the applicant to undertake in the circumstances of the applicant's case.

(6) The Registrar may grant an application under this rule subject to the condition that the applicant agrees to comply with such undertakings with regard to continuing professional development as the Registrar considers appropriate in the applicant's case.

(7) The Registrar may refuse any application under this rule which is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or otherwise required by the Registrar.

(8) The Registrar must refuse the application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if A's entry in Part 1 or, as the case may be, Part 2 of the Register was removed from the relevant part of the Register because of a failure to provide any document, evidence or information and that document, evidence or information is not included in the application; or

(c)if A has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fees in respect of the application.

(9) An entry restored to Part 1 or, as the case may be, Part 2 of the Register under this rule-

(a)is still to be treated as having been entered in that part of the Register; and

(b)is valid for the same period as the period for which the entry would have been valid, or would have been treated as valid, under article 25 of the Order had it not been removed from the Register by the Registrar.

Restoration of an annotation made to an entry in the Register

17.-(1) Subject to the following paragraphs, applicants for the restoration of an annotation in respect of a specialisation made to an entry in Part 1 or, as the case may be, Part 2 of the Register may apply to the Registrar.

(2) An application under this rule must be made to the Registrar using the relevant application form, which must be in such form as the Council may from time to time determine, before the end of the period of twelve months beginning with-

(a)the date on which the annotation in respect of a specialisation made to the entry was removed from the relevant part of the Register pursuant to an application for voluntary removal under rule 14; or

(b)the date on which the entry in the relevant part of the Register to which the annotation relates was removed from that part of the Register under or by virtue of a provision specified in article 37(1)(a) to (g) of the Order.

(3) The application form must, in particular-

(a)require the applicant to-

(i)specify-

(aa)the applicant's full name, home address and contact details (including a telephone number and electronic mail address, where possible),

(bb)the part of the Register to which the application relates, and

(cc)the number of the entry in the Register to which the application relates, and

(ii)provide any other necessary supporting documents, information or evidence as mentioned in the application form;

(b)include a demand that the applicant pay the prescribed fee in respect of the application; and

(c)require the applicant to sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) The Registrar must consider-

(a)whether the applicant should be required to undertake any additional education, training or experience before the annotation made to the applicant's entry is restored to the Register; and

(b)whether the applicant should be required to undertake any additional continuing professional development after the annotation made to the applicant's entry is restored to the Register,

and, where necessary, the Registrar may determine the additional education, training or experience or additional continuing professional development that it is appropriate for the applicant to undertake in the circumstances of the applicant's case.

(6) The Registrar may grant an application under this rule subject to the condition that the applicant agrees to comply with such undertakings with regard to continuing professional development as the Registrar considers appropriate in the circumstances of the applicant's case.

(7) The Registrar may refuse any application under this rule which is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or otherwise required by the Registrar.

(8) The Registrar must refuse an application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if an annotation to the applicant's entry in Part 1 or, as the case may be, Part 2 of the Register was removed from the relevant part of Register because of a failure to provide any document, information or evidence and that document, information or evidence is not included in the application; or

(c)if A has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

PART 4Fraudulent and incorrect entries: Parts 1, 2, 4 and 5 of the Register

Notice of Intention to Remove: stage 1

18.-(1) Paragraph (2) applies where the Registrar has reasonable grounds for believing-

(a)that the entry of a registrant ("R") in Part 1 or, as the case may be, Part 2, 4 or 5 of the Register may have been fraudulently procured or incorrectly made; or

(b)that R's fitness to practise was impaired at the time when R was entered in the relevant part of the Register and R had not informed the Registrar of the relevant matter before R's name was entered in that part of the Register.

(2) In the circumstances set out in paragraph (1), the Registrar-

(a)may serve a Notice of Intention to Remove on R which notifies R in writing that the Registrar is considering whether to remove R's entry from the relevant part of the Register; and

(b)must consider whether or not to refer the matter to the Fitness to Practise Committee under rule 6(7) of the Fitness to Practise Rules.

(3) If the Registrar has reasonable grounds for believing that R's fitness to practise is impaired, the Registrar may decide to refer the matter to the Fitness to Practise Committee in accordance with rule 6(7) of the Fitness to Practise Rules instead of serving a Notice of Intention to Remove on R.

(4) Before serving a Notice of Intention to Remove on R, the Registrar may make such inquiries, including the instruction of external agents and investigators, and the commissioning of medical reports, as the Registrar considers necessary or expedient.

(5) The Notice of Intention to Remove must-

(a)set out the grounds for believing that-

(i)R's entry in Part 1 or, as the case may be, Part 2, 4 or 5 of the Register may have been fraudulently procured or incorrectly made, or

(ii)R's fitness was impaired at the time of R's entry in the relevant part of the Register and R had not informed the Registrar of the relevant matter before R's name was entered in that part of the Register;

(b)be accompanied by copies of any evidence that is in a form which can be copied and on which the Registrar would rely in any proceedings under this Part to remove R's entry from the relevant part of the Register;

(c)invite R to submit written representations and any relevant evidence to the Registrar no later than 28 days after service of the Notice, as to why R's entry in the relevant part of the Register should not be removed;

(d)inform R that, should R fail to submit written representations to the Registrar within the period stipulated in sub-paragraph (c), R's entry in the relevant part of Register will be removed; and

(e)except in cases where the Registrar has reasonable grounds for believing that R's entry in the relevant part of the Register was incorrectly made, invite R to indicate whether or not R wishes the matter to be considered at a hearing.

(6) In this Part, "the relevant matter" means-

(a)any matter referred to in article 51(1)(e) to (n) of the Order which exists in relation to R; or

(b)any adverse report relating to R's physical or mental health.

Subsequent action by Registrar: stage 2

19.-(1) Where the Registrar has issued a Notice of Intention to Remove and has not received any representations from R within the period stipulated in rule 18(5)(c), the Registrar must remove R's entry from Part 1 or, as the case may be, Part 2, 4 or 5 of the Register.

(2) Where the Registrar receives representations from R within the period stipulated in rule 18(5)(c), the Registrar-

(a)must consider the representations and any evidence received; and

(b)may make such further inquiries (including obtaining legal advice) as the Registrar considers necessary.

(3) The Registrar must close the matter and advise R accordingly where the Registrar is satisfied that-

(a)R's entry in the relevant part of the Register was not fraudulently procured or incorrectly made; or

(b)R's fitness to practise was not impaired at the time R's name was entered in the relevant part of the Register, or that it was so impaired but that R had informed the Registrar of the relevant matter before R's name was entered in that part of the Register.

(4) Where the Registrar is minded to determine that-

(a)R's entry in Part 1 or, as the case may be, Part 2, 4 or 5 of the Register was fraudulently procured or incorrectly made; or

(b)R's fitness to practise was impaired at the time R's name was entered in the relevant part of the Register and R had not informed the Registrar about the relevant matter before R's name was entered in that part of the Register,

if the Registrar is minded to rely, when making that determination, on evidence that was obtained as a result of the Registrar's further inquiries, paragraph (5) applies, but in all other cases, the Registrar must determine the matter in accordance with rule 20(1)(b) or (2).

(5) Where this paragraph applies, the Registrar must send to R the additional evidence on which the Registrar is minded to rely, and if R has not already requested a hearing or is not entitled to one, invite R, no later than 28 days after service of the additional evidence-

(a)to submit written representations and any relevant additional evidence to the Registrar; or

(b)except in cases where the Registrar has reasonable grounds for believing that R's entry in Part 1 or, as the case may be, Part 2, 4 or 5 of the Register was incorrectly made, invite R once again to indicate whether or not R wishes the matter to be considered at a hearing.

Decisions in contested cases: stage 3

20.-(1) The Registrar must determine the matter if R does not request a hearing or is not entitled to one-

(a)after the period stipulated in rule 19(5); or

(b)if no such period need be stipulated, once the Registrar has taken a decision to that effect.

(2) Where R has requested a hearing (as a response to the invitation in the Notice of Intention to Remove or the notification under rule 19(5))-

(a)the Registrar must refer the matter to the Fitness to Practise Committee, which must hold a hearing in accordance with rule 33 of the Fitness to Practise Rules, for the purposes of making findings of fact in relation to the matter and advising the Registrar accordingly; and

(b)once the Registrar has received the advice of the Fitness to Practise Committee, the Registrar must determine the matter.

(3) Where the Registrar determines that-

(a)R's entry in Part 1 or, as the case may be, Part 2, 4 or 5 of the Register was fraudulently procured or incorrectly made; or

(b)R's fitness to practise was impaired at the time R's name was entered in the relevant part of the Register and R had not informed the Registrar of the relevant matter before R's name was entered in that part of the Register,

the Registrar must remove R's entry from the relevant part of the Register, in accordance with article 29(3) or 30(1) of the Order, whichever is appropriate in R's case.

(4) Where the Registrar determines that-

(a)R's entry in the relevant part of the Register was not fraudulently procured or incorrectly made; or

(b)R's fitness to practise was not impaired at the time R's name was entered in the relevant part of the Register, or that it was so impaired but that R had informed the Registrar of the relevant matter before R's name was entered in that part of the Register,

the Registrar must close the matter and notify R accordingly.

PART 5Applications relating to Part 3 of the Register

Applications: general

21. The Council may make such provision as it considers appropriate for applications under this Part to be made on line to the Registrar.

Entry of premises in the Register

22.-(1) Subject to the following paragraphs, applicants for the entry of premises in Part 3 of the Register may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule must be made to the Registrar by the person who is, or intends to be, the person carrying on a retail pharmacy business at the premises to which the application relates.

(3) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's full name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises to which the application relates,

(iii)whether the applicant is aware that the premises to which the application relates have previously been entered in Part 3 of the Register,

(iv)the name under which the retail pharmacy business that is, or is to be, carried on at the premises trades or is to trade,

(v)whether the applicant is, or will be, a person lawfully conducting a retail pharmacy business at the premises within the meaning of Part 4 of the Act,

(vi)the date, or intended date, of the commencement of the retail pharmacy business carried on, or to be carried on, at the premises,

(vii)where the retail pharmacy business is, or is to be, carried on at the premises by a representative, the name of the responsible pharmacist;

(viii)where the applicant is a partner in a partnership, the names of all the partners in the partnership,

(ix)where the applicant is a body corporate-

(aa)the names of all of the directors of the body corporate, and

(bb)the name of the superintendent pharmacist;

(b)include a demand that the applicant pay the prescribed fee in respect of the application;

(c)require the applicant to provide-

(i)a description of the premises to which the application relates,

(ii)details of the type of activities undertaken, or intended to be undertaken, at the premises,

(iii)a plan, drawn to scale, of the internal layout of the premises showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored,

(iv)a declaration-

(aa)confirming that the standards set in rules under article 7(1) of the Order in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business carried on, or intended to be carried on, at the premises, and

(bb)providing details of any relevant offence or relevant investigation within the meaning of article 7(6)(a) and (b) of the Order;

(d)provide any other necessary supporting documents, information or evidence as mentioned in the application form;

(e)inform the applicant that, if the declaration included in the application is not completed to the satisfaction of the Registrar, the Registrar may refuse to enter the premises in Part 3 of the Register because the conditions specified in section 74B of the Act are not met; and

(f)require the applicant to sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is, or is to be, carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is, or is to be, carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is, or is to be, carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(6) Where the premises to which the application relates have previously been entered in Part 3 of the Register, the Registrar may dispense with any of the requirements under this rule for the applicant to provide such documents, information or evidence in support of the application as the Registrar may determine in the circumstances of the applicant's case.

(7) The Registrar must refuse any application for the entry of premises in Part 3 of the Register if-

(a)it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or

(b)the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

Variation or revocation of conditions of entry of premises entered in the Register

23.-(1) Subject to the following paragraphs, applicants for variation or revocation of any of the conditions to which an entry of premises entered in Part 3 of the Register is subject may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule may be made to the Registrar by the person carrying on a retail pharmacy business at premises entered in Part 3 of the Register where the entry of the premises in the Register is subject to one or more conditions.

(3) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's full name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises at which the retail pharmacy business is carried on,

(iii)the number of the entry of the premises entered in the Register to which the application relates,

(iv)the name under which the retail pharmacy business carried on at the premises trades,

(v)where the retail pharmacy business is carried on at the premises by a representative, the name of the responsible pharmacist,

(vi)where the retail pharmacy business is carried on at the premises by a body corporate, the name of the superintendent pharmacist,

(vii)details of any improvement notices to which the person carrying on a retail pharmacy business at the premises is subject,

(viii)details of any conditions to which the entry of the premises entered in Part 3 of the Register is subject,

(ix)the condition (or conditions) imposed on the entry of the premises entered in Part 3 of the Register to which the application relates,

(x)whether the application is an application for variation or revocation of such a condition (or such conditions),

(xi)the grounds on which the application is made including any reasons why the applicant considers that the relevant condition (or conditions) cannot be complied with,

(xii)if the application is an application to vary a condition (or conditions), the terms of the variation that is being sought; and

(b)require the applicant to-

(i)provide any other necessary supporting documents, information or evidence as mentioned in the application form, and

(ii)sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(6) The Registrar must refuse any application under this rule-

(a)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or

(b)if the Registrar considers that--

(i)to vary or revoke the condition (or conditions) to which the application relates would prejudice the health, safety or well-being of members of the public, or

(ii)it is necessary to retain the relevant condition (or conditions) in order to ensure the safe and effective practice of pharmacy at the premises.

(7) If the Registrar grants an application under this rule-

(a)the Registrar must ensure that an appropriate alteration to the Register is made to record any variation or revocation of a condition (or conditions) to which the entry of the premises entered in Part 3 of the Register is subject; and

(b)the Registrar may charge a fee, of such amount as may reasonably be determined by the Registrar in the circumstances of the application, in connection with the cost of making an appropriate alteration to the Register.

Renewal of an entry of premises entered in the Register

24.-(1) Subject to the following paragraphs, applicants for the renewal of an entry of premises entered in Part 3 of the Register may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises at least two months before the date on which the entry of the premises entered in Part 3 of the Register would cease to be valid if not renewed.

(3) The Registrar must send to each person carrying on a retail pharmacy business at premises which are entered in Part 3 of the Register the relevant application form for the renewal of the entry relating to the premises at least three months before the date on which the entry of the premises entered in that part of the Register would cease to be valid if not renewed.

(4) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's full name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises to which the application relates,

(iii)the number of the entry of the premises entered in the Register to which the application relates,

(iv)the name under which the retail pharmacy business carried on at the premises trades,

(v)whether the applicant is a person lawfully conducting a retail pharmacy business at the premises within the meaning of Part 4 of the Act,

(vi)the date of the commencement of the retail pharmacy business carried on at the premises,

(vii)where the applicant is a partner in a partnership, the names of all the partners in the partnership,

(viii)where the applicant is a body corporate-

(aa)the names of all of the directors of the body corporate, and

(bb)the name of the superintendent pharmacist, and

(ix)where the retail pharmacy business is carried on at the premises by a representative, the name of the responsible pharmacist, and

(b)include a demand that the applicant pay the prescribed fee in respect of the application;

(c)require the applicant to provide-

(i)a description of the premises to which the application relates,

(ii)details of any conditions to which the entry of the premises entered in Part 3 of the Register is subject,

(iii)details of any improvement notices to which the person carrying on a retail pharmacy business at the premises is subject,

(iv)details of the type of activities undertaken at the premises, and

(v)a declaration-

(aa)confirming that the standards set in rules under article 7(1) of the Order in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business carried on at the premises, and

(bb)providing details of any relevant offence or relevant investigation within the meaning of article 7(6)(a) and (b) of the Order;

(d)inform the applicant that if the declaration included in the application is not completed to the satisfaction of the Registrar, the Registrar may refuse to renew the entry of the premises in Part 3 of the Register; and

(e)require the applicant to sign and date the application.

(5) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(6) For the purposes of paragraph (4)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(7) The Registrar must not renew an entry of premises entered in Part 3 of the Register-

(a)if the application is not received by the Registrar within the time limit specified in paragraph (2);

(b)if the application is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

(8) The Registrar may only renew the entry of premises entered in Part 3 of the Register for a period exceeding one year beginning with the date on which that entry would otherwise have ceased to be valid-

(a)if the entry of the premises in Part 3 of the Register is not subject to any conditions imposed by virtue of section 74D of the Act;

(b)if the person carrying on a retail pharmacy business at the premises is not subject to the terms of an improvement notice served under article 13 of the Order; and

(c)if the period for which the entry is renewed does not exceed 36 months from the date on which the entry would otherwise have ceased to be valid if not renewed.

(9) For the purposes of section 74A(7) of the Act, the prescribed circumstances are that-

(a)the Registrar has received an application under this rule for the renewal of an entry of premises entered in Part 3 of the Register before the end of the period specified in paragraph (2); and

(b)the Registrar has not determined the application before the date on which the entry in Part 3 of the Register to which the application relates would cease to be valid if not renewed.

Annotations made to an entry of premises entered in the Register

25.-(1) Subject to the following paragraphs, applicants may apply to the Registrar for an annotation in respect of a specialisation to be made to an entry of premises entered in Part 3 of the Register using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises to which the application relates.

(3) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's full name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises at which the retail pharmacy business is carried on,

(iii)the number of the entry of the premises entered in the Register to which the application relates, and

(iv)the name under which the retail pharmacy business carried on at the premises trades;

(b)include a demand that the applicant pay the prescribed fee in respect of the application; and

(c)require the applicant to-

(i)specify the type of specialisation which is to be the subject matter of the annotation,

(ii)declare the applicant's intention to adhere (or to continue to adhere) to the standards set by the Council in rules under article 7(1) of the Order relating to the safe and effective practice of pharmacy at registered pharmacies,

(iii)provide any other necessary supporting documents, information and evidence as mentioned in the application form, and

(iv)sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(6) Where the Registrar grants an application under this rule, the Registrar must ensure that an appropriate annotation is made to the entry of the premises entered in Part 3 of the Register to denote the type of specialisation that relates to the retail pharmacy business carried on at the premises.

(7) The Registrar must refuse any application made under this rule-

(a)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or

(b)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

Renewal of an annotation made to an entry of premises entered in the Register

26.-(1) Subject to the following paragraphs, applicants for the renewal of an annotation in respect of a specialisation made to an entry of premises entered in Part 3 of the Register may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises to which the application relates at least two months before the date on which the entry of the premises in Part 3 of the Register would cease to be valid if not renewed.

(3) The Registrar must send an application form to each person carrying on a retail pharmacy business at premises entered in Part 3 of the Register, where the entry of the premises entered in that part of the Register is subject to an annotation to denote a specialisation, at least three months before the date on which that entry would cease to be valid if not renewed.

(4) If a person carrying on a retail pharmacy business at premises entered in Part 3 of the Register, where the entry of the premises entered in that part of the Register is subject to an annotation to denote a specialisation, has not received an application form for the renewal of that annotation at least three months before the date on which that entry would cease to be valid if not renewed, that person must notify the Registrar accordingly.

(5) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises at which the retail pharmacy business is carried on,

(iii)the number of the entry of the premises entered in the Register to which the application relates,

(iv)the name under which the retail pharmacy business carried on at the premises trades,

(v)the annotation, or annotations, to which the application relates;

(b)include a demand that the applicant pay the prescribed fee in respect of the application; and

(c)require the applicant to-

(i)provide any other necessary supporting documents, information or evidence as mentioned in the application form, and

(ii)sign and date the application.

(6) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(7) For the purposes of paragraph (5)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(8) The Registrar must refuse any application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

Voluntary removal of an entry of premises or an annotation from the Register

27.-(1) Subject to the following paragraphs, applicants for the voluntary removal of an entry of premises entered in Part 3 of the Register from that part of the Register, or for the removal of an annotation in respect of a specialisation made to such an entry, may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.

(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises to which the application relates.

(3) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises to which the application relates,

(iii)whether the application is for the removal of an entry of premises entered in Part 3 of the Register from that part of the Register or for the removal of an annotation in respect of a specialisation made to such an entry,

(iv)the number of the entry of the premises entered in the Register to which the application relates,

(v)the name under which the retail pharmacy business carried on at the premises trades,

(vi)where the retail pharmacy business is carried on at the premises by a representative, the name of the responsible pharmacist,

(vii)where the applicant is a partner in a partnership, the names of all the partners in the partnership,

(viii)where the applicant is a body corporate-

(aa)the names of all of the directors of the body corporate, and

(bb)the name of the superintendent pharmacist;

(b)require the applicant to-

(i)state the reason for the application,

(ii)declare that the applicant is not aware of any investigation by any enforcement or regulatory body, or proceedings brought by such a body, that relate to the premises,

(iii)provide any necessary supporting documents, information or evidence as mentioned in the application form, and

(iv)sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(6) Where the Registrar grants an application under this rule, the Registrar must ensure that an appropriate alteration is made to Part 3 of the Register removing the entry or, as the case may be, the annotation in respect of a specialisation made to the entry, from that part of the Register.

Restoration of an entry of premises entered in the Register: general

28.-(1) Subject to the following paragraphs, applicants for the restoration of an entry of premises entered in Part 3 of the Register that has been removed from that part of the Register-

(a)under article 14(4)(a) of the Order;

(b)under section 74A(7) of the Act (registration of premises: Great Britain); or

(c)by virtue of an application under section 74G of the Act (voluntary removal from the register: Great Britain);

may apply to the Registrar to have the entry restored to Part 3 of the Register using the relevant application form which must be in such form as the Council may from time to time determine.

(2) Applications under this rule must be made to the Registrar by the person who, immediately before the removal, was the person carrying on a retail pharmacy business at the premises no later than twelve months from the date on which the entry was removed from Part 3 of the Register.

(3) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises at which the retail pharmacy business is to be carried on,

(iii)the number of the entry of the premises entered in the Register to which the application relates,

(iv)the name under which the retail pharmacy business that is to be carried on at the premises trades,

(v)where the retail pharmacy business is to be carried on at the premises by a representative, the name of the responsible pharmacist,

(vi)where the applicant is a partner in a partnership, the names of all the partners in the partnership,

(vii)where the applicant is a body corporate-

(aa)the names of all of the directors of the body corporate, and

(bb)the name of the superintendent pharmacist, and

(viii)the intended date of commencement of the retail pharmacy business that is to be carried on at the premises;

(b)include a demand that the applicant pay the prescribed fee in respect of the application;

(c)require the applicant to provide-

(i)details of any conditions to which the entry of the premises entered in Part 3 of the Register was subject immediately prior to its removal from that part of the Register,

(ii)details of any improvement notices to which the person carrying on the retail pharmacy business at the premises was subject immediately prior to the removal of the entry of the premises from Part 3 of the Register,

(iii)details of the type of activities to be undertaken at the premises,

(iv)a plan, drawn to scale, of the internal layout of the premises showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored, and

(v)a declaration-

(aa)confirming that the standards set in rules under article 7(1) of the Order in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business that is to be carried on at the premises, and

(bb)providing details of any relevant offence or relevant investigation within the meaning of article 7(6)(a) and (b) of the Order; and

(d)require the applicant to-

(i)declare whether there has been a change in the name under which the retail pharmacy business that is to be carried on at the premises trades,

(ii)provide any necessary supporting documents, information or evidence as mentioned in the application form, and

(iii)sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is to be carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is to be carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is to be carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(6) The Registrar must refuse the application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar;

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application; or

(d)if the Registrar considers that restoring the entry of the premises to Part 3 of the Register would prejudice the health, safety or well-being of members of the public.

Restoration of an entry of premises in the Register: change of ownership

29.-(1) Subject to the following paragraphs, applicants for the restoration of an entry of premises entered in Part 3 of the Register to that part of the Register may, where the entry has been removed from the Register under section 74H of the Act (change of ownership of retail pharmacy business: Great Britain), apply to the Registrar to have the entry restored to Part 3 of the Register using the relevant application form which must be in such form as the Council may from time to time determine.

(2) Applications under this rule must be made to the Registrar by the person who is to be a person carrying on a retail pharmacy business at the premises before the end of the period of twelve months beginning with the date on which the entry was removed from Part 3 of the Register.

(3) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises at which the retail pharmacy business is to be carried on,

(iii)the number of the entry of the premises entered in the Register to which the application relates,

(iv)the name under which the retail pharmacy business carried on at the premises is to trade,

(v)the intended date of commencement of the retail pharmacy business to be carried on at the premises,

(vi)where the applicant is a partner in a partnership, the names of all the partners in the partnership,

(vii)where the applicant is a body corporate-

(aa)the names of all of the directors of the body corporate, and

(bb)the name of the superintendent pharmacist, and

(viii)where the retail pharmacy business is to be carried on at the premises by a representative, the name of the responsible pharmacist;

(b)include a demand that the applicant pay the prescribed fee in respect of the application;

(c)require the applicant to provide-

(i)a description of the premises to which the application relates,

(ii)details of any conditions to which the entry of the premises in Part 3 of the Register was subject immediately prior to its removal from that part of the Register,

(iii)details of any improvement notices to which the person carrying on a retail pharmacy business at the premises was subject immediately prior to the removal of the entry of the premises from Part 3 of the Register,

(iv)details of the type of activities to be undertaken at the premises,

(v)a plan, drawn to scale, of the internal layout of the premises showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored, and

(vi)a declaration-

(aa)confirming that the standards set by the Council in rules under article 7(1) of the Order that are to be met in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business to be carried on at the premises, and

(bb)providing details of any relevant offence or relevant investigation within the meaning of article 7(6)(a) and (b) of the Order; and

(d)require the applicant to sign and date the application.

(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is to be carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is to be carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is to be carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(6) The Registrar may treat an application for restoration made under this rule as an application for the renewal of an entry of premises entered in Part 3 of the Register made under rule 24 as well as an application for restoration made under this rule if there is insufficient time available for the Registrar to process the application for restoration before the date on which the entry, if restored, would cease to be valid if not renewed.

(7) The Registrar must refuse the application under this rule-

(a)if it is not received by the Registrar within the time limit specified in paragraph (2);

(b)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar;

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application; or

(d)if the Registrar considers that restoring the entry of the premises to Part 3 of the Register would prejudice the health, safety or well-being of members of the public.

Restoration of annotations made to an entry of premises in the Register

30.-(1) Paragraph (2) applies-

(a)where an entry of premises entered in Part 3 of the Register has been removed from that part of the Register under -

(i)article 14(4)(a) of the Order,

(ii)under section 74A(7) of the Act (registration of premises: Great Britain),

(iii)by virtue of an application under section 74G of the Act (voluntary removal from the register: Great Britain), or

(iv)under section 74H(5) of the Act (change of ownership of retail pharmacy business: Great Britain),

and an application has been made to the Registrar under rule 28 or rule 29 for the restoration of that entry to Part 3 of the Register; or

(b)where an annotation in respect of a specialisation made to an entry of premises entered in Part 3 of the Register has been removed from that part of the Register by virtue of an application under rule 27 of these Rules.

(2) Where paragraph (1) applies, applicants may apply to the Registrar to have an annotation in respect of a specialisation made to an entry of premises entered in Part 3 of the Register restored to that part of Register using the relevant application form which must be in such form as the Council may from time to time determine.

(3) An application under this rule must be made to the Registrar before the end of the period of twelve months beginning with the date on which the annotation was removed from the Register.

(4) The application form must, in particular-

(a)require the applicant to specify-

(i)the applicant's name, address and contact details (including a telephone number and electronic mail address, where possible),

(ii)the full postal address of the premises at which the retail pharmacy business is, or is to be, carried on,

(iii)the number of the entry of the premises entered in the Register to which the application relates, and

(iv)the name under which the retail pharmacy business carried on, or to be carried on, at the premises trades;

(b)include a demand that the applicant pay the prescribed fee in respect of the application; and

(c)require the applicant to-

(i)provide any other necessary supporting documents, information or evidence as mentioned in the application form, and

(ii)sign and date the application.

(5) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.

(6) For the purposes of paragraph (4)(a)(i), the address of the applicant is-

(a)where the retail pharmacy business is, or is to be, carried on at the premises by an individual, that individual's home address in the Register;

(b)where the retail pharmacy business is, or is to be, carried on at the premises by a partnership, the address of the principal office of that partnership; or

(c)where the retail pharmacy business is, or is to be, carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.

(7) The Registrar may refuse any application under this rule which is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar.

(8) The Registrar must refuse the application-

(a)if the application is not received by the Registrar within the time limit specified in paragraph (3);

(b)if the annotation made to an entry of premises entered in Part 3 of the Register was removed from that part of the Register because of a failure to provide any document, evidence or information and the relevant document, information or evidence is not included in the application; or

(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.

PART 6Fraudulent and incorrect entries: Part 3 of the Register

Notice of Intention to Remove: stage 1

31.-(1) Paragraph (2) applies where the Registrar has reasonable grounds for believing that an entry of premises entered in Part 3 of the Register may have been fraudulently procured or incorrectly made.

(2) In the circumstances set out in paragraph (1), the Registrar-

(a)may serve a Notice of Intention to Remove on the person carrying on a retail pharmacy business at the premises ("P") which notifies P in writing that the Registrar is considering whether to remove the entry of the premises entered in Part 3 of the Register to which the Notice relates from that part of the Register; and

(b)may, if the Registrar considers that the matter may constitute misconduct for the purposes of disqualification proceedings under section 80 of the Act (power for relevant disciplinary committee to disqualify and direct removal from the register), refer the matter to the relevant disciplinary committee.

(3) Before serving a Notice of Intention to Remove on P, the Registrar may make such inquiries, including the instruction of external agents and investigators, as the Registrar considers necessary or expedient.

(4) The Notice of Intention to Remove must-

(a)set out the grounds for believing that the entry of the premises entered in Part 3 of the Register may have been fraudulently procured or incorrectly made;

(b)be accompanied by copies of any evidence that is in a form which can be copied and on which the Registrar would rely in any proceedings under this Part to remove the entry of the premises from Part 3 of the Register;

(c)invite P to submit written representations and any relevant evidence to the Registrar no later than 28 days after service of the Notice, as to why the entry of the premises entered in Part 3 of the Register should not be removed from that part of the Register;

(d)inform P that should P fail to submit written representations to the Registrar within the period stipulated in sub-paragraph (c), the entry of the premises entered in Part 3 of the Register will be removed from that part of the Register; and

(e)except in cases where the Registrar has reasonable grounds for believing that the entry of the premises entered in Part 3 of the Register was incorrectly made, invite P to indicate whether or not P wishes the matter to be considered at a hearing.

Subsequent action by Registrar: stage 2

32.-(1) Where the Registrar has issued a Notice of Intention to Remove and has not received any representations from P within the period stipulated in rule 31(4)(c), the Registrar must remove the entry of the premises from Part 3 of the Register.

(2) Where the Registrar does receive representations within the period stipulated in rule 31(4)(c), the Registrar-

(a)must consider the representations and any evidence received; and

(b)may make such further inquiries (including obtaining legal advice) as the Registrar considers necessary.

(3) The Registrar must close the matter and advise P accordingly where the Registrar is satisfied that the entry of the premises entered in Part 3 of the Register was not fraudulently procured or incorrectly made.

(4) Where the Registrar is minded to determine that the entry of the premises entered in Part 3 of the Register was fraudulently procured or incorrectly made, if the Registrar is minded to rely, when making that determination, on evidence that was obtained as a result of the Registrar's further inquiries, paragraph (5) applies, but in all other cases, the Registrar must determine the matter in accordance with rule 33(1)(b) or (2).

(5) Where this paragraph applies, the Registrar must send to P the additional evidence on which the Registrar is minded to rely, and if P has not already requested a hearing or is not entitled to one, invite P, no later than 28 days after service of the additional evidence-

(a)to submit written representations and any relevant additional evidence to the Registrar; or

(b)except in cases where the Registrar has reasonable grounds for believing that the entry of the premises entered in Part 3 of the Register was incorrectly made, invite P once again to indicate whether or not P wishes the matter to be considered at a hearing.

Decisions in contested cases: stage 3

33.-(1) The Registrar must determine the matter if P does not request a hearing or is not entitled to one-

(a)after the period stipulated in rule 32(5); or

(b)if no such period need be stipulated, once the Registrar has taken a decision to that effect.

(2) Where P has requested a hearing (as a response to the invitation in the Notice of Intention to Remove or the notification under rule 32(5))-

(a)the Registrar must refer the matter to the relevant disciplinary committee for investigation for the purposes of making findings of fact in relation to the matter and advising the Registrar accordingly; and

(b)once the Registrar has received the advice of the relevant disciplinary committee, the Registrar must determine the matter.

(3) Where the Registrar determines that the entry of the premises entered in Part 3 of the Register was fraudulently procured or incorrectly, made the Registrar must remove the entry of the premises from that part of the Register in accordance with article 29(3) of the Order.

(4) Where the Registrar determines that the entry of the premises entered in Part 3 of the Register was not fraudulently procured or incorrectly made, the Registrar must close the matter and notify P accordingly.

Given under the official seal of the General Pharmaceutical Council this 3rd day of June 2010.

Robert Nicholls CBE

Chair

Duncan Rudkin

Chief Executive

EXPLANATORY NOTE

(This note is not part of the Order)

This Order approves The General Pharmaceutical Council (Registration) Rules 2010 ("the Rules") made by the General Pharmaceutical Council ("the Council") under the Pharmacy Order 2010 (S.I.2010/231) ("the Order"). The Rules set out various matters relating to the register established and maintained under article 19 of the Order ("the Register").

Part 1 contains preliminary matters, including general provisions relating to the service of documents and the waiver and non-charging of fees in respect of applications under Parts 3 and 5 of the Rules. Provision is also made to enable the payment by direct debit in instalments or otherwise of fees in respect of applications.

Part 2 makes provision relating to the form and keeping of the Register. In particular, it requires the Register to be kept in writing and securely. Part 2 also contains provisions relating to the recording of fitness to practise matters and requiring registrants to notify the Registrar in writing of any changes to their name or contact details.

Part 3 makes detailed provision in respect of the form and manner of various applications relating to Parts 1 and 2 of the Register (pharmacists and pharmacy technicians). These applications relate to entries in and annotations in respect of specialisations made to entries in the Register and also to the renewal and restoration of such entries and annotations. Applications, which must be made on the relevant application form which must be in such form as the Council may from time to time determine, have to be accompanied by the fee prescribed in rules made under article 36 of the Order in respect of the application. Applications must generally be refused if they are not made within the prescribed time limit and if the prescribed fee is not paid. Provision is made for the voluntary removal of entries in, and annotations made to entries in, Parts 1 and 2 of the Register. Applications for the voluntary removal of an entry from the Register will generally be refused where there is an ongoing investigation or there are outstanding proceedings relating to a registrant's fitness to practise. General provision is also included to enable applications to be made on line.

Part 4 contains a procedure to be followed by the Registrar for dealing with entries in Parts 1, 2, 4 and 5 of the Register that may have been fraudulently procured or incorrectly made, or where the fitness to practise of a registrant was impaired at the time of the registrant's entry in the Register but this was not declared to the Registrar. In these cases, before determining the matter, the Registrar may serve a Notice of Intention to Remove, and the registrant may elect to have a hearing (which will be before the Council's Fitness to Practise Committee) or for the case to be determined without a hearing. The Registrar must also consider whether or not to refer the matter to the Council's Fitness to Practise Committee.

Part 5 makes detailed provision in respect of the form and manner of various applications relating to Part 3 of the Register (registered pharmacies). These applications relate to entries of premises entered in, and annotations in respect of specialisations made to entries in, Part 3 of the Register and also to the renewal and restoration of such entries and annotations. Applications, which must be made on the relevant application form which must be in such form as the Council may from time to time determine, have to be accompanied by the fee prescribed in rules made under article 36 of the Order in respect of the application. Applications must generally be refused if they are not made within the prescribed time limit and if the prescribed fee is not paid. Similar provision to that contained in Part 3 of these Rules is also made for the voluntary removal of entries of premises entered in, and annotations in respect of specialisations made to entries of premises entered in, Part 3 of the Register. Applications for the voluntary removal of an entry from the Register will also generally be refused where there is an ongoing investigation or there are outstanding proceedings relating to the retail pharmacy business carried on at the registered pharmacy. General provision is also included to enable applications to be made on line.

Part 6 contains a procedure to be followed by the Registrar for dealing with entries of premises entered in Part 3 of the Register that may have been fraudulently procured or incorrectly made. In these cases, before determining the matter, the Registrar may serve a Notice of Intention to Remove on the person carrying on a retail pharmacy business at the premises entered in Part 3 of the Register, that person may elect for a hearing or for the case to be determined without a hearing. The Registrar must also consider whether the matter constitutes misconduct for the purposes of disqualification proceedings under section 80 of the Medicines Act 1968 (c.67)).