S.I. No. 494 of 2008

PHARMACEUTICAL SOCIETY OF IRELAND (REGISTRATION) RULES 2008

The Council of the Pharmaceutical Society of Ireland, in exercise of thefunctions conferred on the said Society by section 11 of the Pharmacy Act 2007 (No. 20 of 2007), hereby makes the following rules.

Dated this 28 day of November 2008

BERNARD LEDDY

President

AMBROSE McLOUGHLIN

Registrar

I consent to the making of these Rules.

GIVEN under my Official Seal,

28 November 2008

MARY HARNEY,

Minister for Health and Children.

S.I. No. 494 of 2008

PHARMACEUTICAL SOCIETY OF IRELAND (REGISTRATION) RULES 2008

ARRANGEMENT OF REGULATIONS

PART 1

GENERAL PROVISIONS

1. Citation.

2. Commencement.

3. Interpretation.

4. Translation of documents.

5. Methods, time and proof of delivery of communication.

6. Date of registration for those persons transferred from the old Registers.

PART 2

INFORMATION TO BE RECORDED IN THE REGISTERS

7. Information to be recorded in the Register of Pharmacists.

8. Information to be recorded in the Register of Druggists.

9. Information to be recorded in the Register of Pharmaceutical Assistants.

10. Information to be recorded in the Register of Retail Pharmacy Businesses.

PART 3

APPLICATIONS FOR REGISTRATION

11. Prescribed requirements for applications for registration and continued registration in the Register of Pharmacists.

12. Prescribed requirements for registration in the Register of Pharmaceutical Assistants.

PART 4

CERTIFICATES OF REGISTRATION

13. Format of certificates of registration for pharmacists.

14. Requirement for and format of certificates of registration for pharmaceutical assistants.

15. Format of certificates of registration for a retail pharmacy business.

PART 5

REMOVAL FROM REGISTERS

16. Removal of registration for failure to make application for continued registration.

17. Removal of registration for failure to pay a fee.

PART 6

THIRD COUNTRY QUALIFICATIONS AS PHARMACISTS

18. Recognition of third country qualifications as qualifications appropriate for practice.

19. Applications for recognition of third country qualifications as qualifications appropriate for practice.

SCHEDULE 1

Particulars to be contained in or to accompany an application for registration in Part A of the Register of Pharmacists

SCHEDULE 2

Particulars to be contained in or to accompany an application for continued registration in Part A of the Register of Pharmacists

SCHEDULE 3

Particulars to be contained in or to accompany an application for continued registration in the Register of Pharmaceutical Assistants

SCHEDULE 4

Particulars to be contained in or to accompany an application for recognition of a third country qualification as a qualification appropriate for practice

S.I. No. 494 of 2008

PHARMACEUTICAL SOCIETY OF IRELAND (REGISTRATION) RULES 2008

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 2nd December, 2008.

The Council of the Pharmaceutical Society of Ireland, in exercise of the functions conferred on the said Society by section 11 of the Pharmacy Act 2007 (No. 20 of 2007), hereby makes the following rules:-

PART 1 GENERAL PROVISIONS

Citation

1. These Rules may be cited as the Pharmaceutical Society of Ireland (Registration) Rules 2008.

Commencement

2. These rules shall come into force on 29 November 2008.

Interpretation

3. (1) In these Rules-

‘Act’ means the Pharmacy Act 2007 (No. 20 of 2007) as amended by the European Communities (Recognition of Professional Qualifications relating to the Profession of Pharmacist) (No. 2) Regulations 2008 ( S.I. No. 489 of 2008 );

‘adaptation period’ has the same meaning as in subsections (8) and (10) of section 16 of the Act;

‘certificate of registration’ means a certificate of registration which is for the time being in force and which has been issued under section 20(1) of the Act or, in the case of a pharmaceutical assistant, under Rule 14(1). Such certificate includes a certificate of continued registration issued under section 20(2) or, as the case may be, under Rule 14(2);

‘Council’ means the Council established pursuant to section 10 of the Act;

‘old Society’ has the meaning assigned to it in section 5(1) of the Act;

‘personal registers’ has the meaning assigned to it in section 13(1)(b) of the Act;

‘pharmaceutical assistant’ means a person who, before the coming into operation of section 4(1) of the Act, was competent, under section 19 of the Pharmacy Act (Ireland), Amendment Act 1890, to transact the business of a pharmacist in his or her temporary absence;

‘Professional Qualifications Directive’ means Directive 2005/36/EC of 7 September 2005 on the recognition of professional qualifications, as amended by Council Directive 2006/100/EC of 20 November 2006 adapting certain Directives in the field of freedom of movement of persons by reason of the access of Bulgaria and Romania;

‘Professional Qualifications Regulations’ means the European Communities (Recognition of Professional Qualifications relating to the Profession of Pharmacist) (No. 2) Regulations 2008 ( S.I. No. 489 of 2008 );

‘Professional Registration Examination’ means the examination conducted in accordance with Part 5 of the Pharmaceutical Society of Ireland (Education and Training) Rules 2008 ( S.I. No. 493 of 2008 );

‘qualification appropriate for practice’ has the meaning assigned to it in section 16 of the Act;

‘registered druggist’ means a person whose name is entered in the Register of Druggists;

‘Register of Pharmacists’, ‘Register of Druggists’, ‘Register of Pharmaceutical Assistants’ and ‘Register of Retail Pharmacy Businesses’ mean the respective registers established under section 13(1) of the Act;

‘registered pharmacist’ means a person whose name is entered in the Register of Pharmacists;

‘registrant’ means a person whose name is entered in the Register of Pharmacists or in the Register of Pharmaceutical Assistants or who is the owner of a retail pharmacy business to which an entry in the Register of Retail Pharmacy Businesses relates;

‘Registrar’ means the Registrar of the Pharmaceutical Society of Ireland, appointed pursuant to paragraph 13(1) of Schedule 1 to the Act;

‘registration number’ means the number assigned as part of the relevant entry in the personal register or as the case may be in the Register of Retail Pharmacy Businesses;

‘relevant state’ means-

(a) a Member State,

(b) a state that is a contracting state to the EEA agreement within the meaning given by the European Communities (Amendment) Act 1993 (other than a member state or the State),

(c) the Swiss Confederation;

‘statutory declaration’ has the meaning assigned to it in the Statutory Declarations Act 1938 (No. 37 of 1938) (as amended);

‘superintendent pharmacist’ means a registered pharmacist acting in the capacity specified in section 27(b), 28(a) or 29(b) of the Act, who is in personal control of the management and administration of the sale and supply of medicinal products, either where such control is exercised in respect of a single retail pharmacy business or in respect of a number of such businesses;

‘supervising pharmacist’ means a registered pharmacist acting in the capacity specified in section 27(c), 28(b) or 29(c) of the Act and who is in whole-time charge of carrying on the retail pharmacy business at the premises of the said business;

‘visiting pharmacist from another relevant state’ means a person to which section 24B(2) of the Act (as inserted by Regulation 9 of the Professional Qualifications Regulations) refers.

(2) In these Rules, unless the context otherwise requires, any reference to a Rule or Schedule shall be construed as a reference to a Rule contained in these Rules or to a Schedule thereto, any reference to a Part shall be construed as a reference to a Part contained in these Rules, and any reference in a Rule or in a Schedule to a paragraph shall be construed as a reference to a paragraph in that Rule or Schedule.

(3) For the purposes of these Rules, that Part of the Register of Pharmacists other than Part B (as created by section 24B of the Act) shall be known as Part A of the said Register.

Translation of documents

4. Where in an application made under Part 3 or Part 6, a document is not in the English or Irish language, the Registrar may require that a translation of that document be provided which shall be translated by a professional translator acceptable to him or her.

Methods, time and proof of delivery of communication

5. (1) Unless otherwise specified in any given case, all notices and other communications under these Rules may be made either-

(a) personally,

(b) by post or hand delivery to the recipients usual address and where the recipient is a registrant, his or her address as it appears in the relevant register,

(c) by email or electronic transmission to the recipient’s email address and where the recipient is a registrant, to his or her email address which has been notified to the Society, or

(d) by facsimile transmission to the recipient’s facsimile number notified in advance by or on behalf of the recipient to the sender.

(2) Unless otherwise proved to the satisfaction of the Council such notice or other communication shall be deemed to have been received-

(a) where sent by ordinary post, at 10 a.m. on the second working day after it was sent;

(b) where sent by hand delivery, at the time of delivery; or

(c) where sent by email, electronic transmission or facsimile transmission, at the time of transmission, except where the transmission is after 6 p.m. on any day or is on a weekend, and the recipient is affected by time limits in making a response, in which case the time of receipt shall be deemed to be 10 a.m. on the next working day.

(3) Where a dispute arises as to the fact or time of service of any notice or other communication by email, by electronic transmission or by facsimile transmission, the sender shall furnish such proof of transmission as the Council may require.

Date of registration for those persons transferred from the old Registers

6. For the purposes of these Rules, the date of registration for those persons who, by virtue of section 15(2) of the Act, were registered in one of the personal registers shall be the date of coming into force of section 20 of the Act.

PART 2 INFORMATION TO BE RECORDED IN THE REGISTERS

Information to be recorded in the Register of Pharmacists

7. (1) Subject to the provisions of this Rule, the following information shall be entered and kept in the Register of Pharmacists for the purposes of section 13(1)(b) of the Act-

(a) in the case of a person whose name, immediately before the coming into force of these Rules, was entered in the Register of Pharmaceutical Chemists for Ireland pursuant to section 24 of the Pharmacy Act (Ireland) 1875 (as amended), the name as it appeared in that Register;

(b) in the case of a person other than a person to whom subparagraph (a) relates, the name as it appears on that person’s birth certificate or current passport;

(c) the address at which the person ordinarily resides;

(d) the address at which the person practises his or her profession as a pharmacist or, where the person does not currently have a fixed practice address or is not currently practising, a statement to either effect whichever is appropriate;

(e) the date of birth of the person;

(f) the date on which the name of the person was first entered in the Register. In the case of those persons whose names were entered in the Register of Pharmaceutical Chemists for Ireland established pursuant to section 24 of the Pharmacy Act (Ireland) 1875 (as amended), the date shall be the date shown for such persons in that Register;

(g) the registration number in the Register of Pharmacists;

(h) the date of expiry of the person’s certificate of registration; and

(i) an indication that the entry relates to a person who is registered in Part A of the Register of Pharmacists.

(2) In a case where a person wishes to use a name in the Register of Pharmacists that is different to that given on his or her birth certificate or passport, whether such change has been brought about on marriage, by deed poll, or by any other legal means, that name may be entered in the Register of Pharmacists in substitution for the original name of the person as it appeared in the Register of Pharmacists, provided that the Registrar is satisfied that the identity of the person who would otherwise have been identified by means of the information required under paragraph (1) relates to that person, and that any education, training and other qualifications as a pharmacist claimed, also relates to such person.

(3) Paragraph (1) shall not apply in the case of a visiting pharmacist from another relevant state. In the case of such a pharmacist, the information entered and kept in the Register of Pharmacists shall include the following-

(a) the name of the visiting pharmacist as it appears in the evidence of professional qualification as a pharmacist presented with the declaration made under section 24A of the Act;

(b) the name of the relevant state in which the visiting pharmacist is lawfully established for the purpose of providing services as a pharmacist;

(c) the address in that relevant state at which the visiting pharmacist is lawfully providing services as a pharmacist;

(d) the registration number in the Register of Pharmacists and the date of such registration;

(e) the date of expiry of the certificate of registration issued to such visiting pharmacist; and

(f) an indication that the entry relates to a person who is registered in Part B of the Register of Pharmacists.

(4) The information referred to in subparagraphs (c) and (e) of paragraph (1) shall not be published on the Internet or made available to the public.

Information to be recorded in the Register of Druggists

8. In pursuance of its obligations under section 15(2)(b) of the Act, the Council shall enter into the Register of Druggists the names of those persons in the form in which they appeared in the Register of Registered Druggists in Ireland kept under the Pharmacy Act, (Ireland) Amendment Act 1890, including any other associated details appearing in that Register as may be appropriate under the Act.

Information to be recorded in the Register of Pharmaceutical Assistants

9. (1) Subject to paragraph (2), the following information shall be entered and kept in the Register of Pharmaceutical Assistants for the purposes of section 13(1)(b) of the Act-

(a) in the case of a person whose name, immediately before the coming into force of these Rules, was entered in the Register of Assistants to Pharmaceutical Chemists kept pursuant to the Pharmacy Act (Ireland) Act 1875 (as amended), the name as it appeared in that Register;

(b) in the case of a person other than a person to whom subparagraph (a) relates, the name as it appears on that person’s birth certificate or current passport, subject to any changes that may be sought on the presentation of a marriage certificate;

(c) the address at which the person ordinarily resides;

(d) the address of the retail pharmacy business in which the person is practising or, where the person is not currently practising, a statement to that effect;

(e) the date of birth of the person;

(f) the date of his or her first registration in the Register of Assistants to Pharmaceutical Chemists kept pursuant to the Pharmacy Act (Ireland) Act 1875 (as amended) or, as the case may be, the date on which the person passed the examination held under section 19 of the Pharmacy Act, (Ireland) (Amendment) Act 1890;

(g) the registration number in the Register of Pharmaceutical Assistants; and

(h) the date of expiry of the person’s certificate of registration issued pursuant to Rule 14.

(2) The information referred to in subparagraphs (c) and (e) of paragraph (1) shall not be published on the Internet or made available to the public.

Information to be recorded in the Register of Retail Pharmacy Businesses

10. The following information shall be entered and kept in the Register of Retail Pharmacy Businesses for the purposes of section 13(1)(c) of the Act-

(a) the name of the pharmacy owner;

(b) where the pharmacy owner is a corporate body, the name of the superintendent pharmacist who is the subject of a statement provided to the Registrar under section 28(a) of the Act, and in the case of a corporate body which is a body controlled under the Companies Acts 1963 to 2006, the address of the registered office of that body and its Companies Office registration number;

(c) the business name of the pharmacy;

(d) the full postal address of the pharmacy premises;

(e) the name of the superintendent pharmacist;

(f) the name of the supervising pharmacist;

(g) the date on which the retail pharmacy business was first entered in the Register by or on behalf of the pharmacy owner;

(h) the registration number in the Register of Retail Pharmacy Businesses; and

(i) the date of expiry of the relevant certificate of registration.

PART 3 APPLICATIONS FOR REGISTRATION

Prescribed requirements for applications for registration and continued registration in the Register of Pharmacists

11. (1) Every application for registration in Part A of the Register of Pharmacists under section 14 of the Act shall be made in writing to the Registrar on a form available from the Council, and shall be signed by the person seeking to be registered.

(2) Every such application shall contain or be accompanied by-

(a) the particulars specified in Schedule 1 to these Rules, and

(b) any fee which may be payable in connection with that application.

(3) Every application for continued registration in Part A of the Register of Pharmacists under section 14 of the Act shall be made-

(a) in writing to the Registrar on a form provided by the Council, and

(b) not later than 30 days before the date on which the applicant’s certificate of registration is due to expire,

and, shall be signed by the person seeking to be registered, whether in ink or by means of an electronic signature.

(4) Every such application for continued registration shall contain or be accompanied by-

(a) the particulars specified in Schedule 2 to these Rules, and

(b) any fee which may be payable in connection with that application.

(5) Where an application for the continued registration of a pharmacist is not made within the period specified in paragraph (3)(b) then such application shall in addition be subject to the payment of a late fee.

(6) Subject to paragraph (7), an application within the meaning of this Rule shall only be valid if-

(a) in the case of an application for first registration, it complies with the provisions of paragraphs (1) and (2), or

(b) in the case of an application for continued registration, it complies with the provisions of paragraphs (3) and (4),

and, in the case of an application to which paragraph (5) applies, the prescribed late fee has been paid.

(7) Where a statutory declaration is required to be furnished as part of an application under this Rule, such may be submitted subsequently as a separate part of the application. An application shall not be deemed valid until both parts have been received by the Registrar.

Prescribed requirements for registration in the Register of Pharmaceutical Assistants

12. (1) Every application for continued registration in the Register of Pharmaceutical Assistants shall be made-

(a) in writing to the Registrar on a form available from the Council, and

(b) not later than 30 days before the date on which the applicant’s certificate of registration is due to expire,

and, shall be signed by the person seeking to be registered, whether in ink or by means of an electronic signature.

(2) Every such application shall contain or be accompanied by-

(a) the particulars specified in Schedule 3 to these Rules, and

(b) any fee which may be payable in connection with that application.

(3) Where an application is not made within the period specified in paragraph (1)(b) then such application shall in addition be subject to the payment of a late fee.

(4) With the exception of paragraphs (1)(b) and (3), this Rule shall also apply to those persons who, having passed the examination held under section 19 of the Pharmacy Act, (Ireland) (Amendment) Act 1890, did not, immediately before the coming into force of these Rules, have their names entered in the Register of Assistants to Pharmaceutical Chemists kept pursuant to the Pharmacy Act (Ireland) 1875 (as amended).

PART 4 CERTIFICATES OF REGISTRATION

Format of certificates of registration for pharmacists

13. (1) A certificate of registration issued pursuant to Section 20 of the Act to a registered pharmacist shall be designed in a format and manner which would reasonably be expected to prevent forgery, impersonation or unauthorised duplication and shall contain at least the following information-

(a) the person’s name as it appears in the Register of Pharmacists;

(b) the person’s registration number;

(c) the number of the certificate of registration which shall be a number unique to that certificate;

(d) the date of issue of the certificate of registration;

(e) the date of expiry of the certificate of registration;

(f) the Part of the Register of Pharmacists in which the person is registered;

(g) a photograph of the person affixed to the certificate in a manner which, in so far as practical, is tamper-proof; and

(h) a statement to the effect that the certificate be displayed, or kept readily available for inspection, at the place of practice, as may be required.

(2) In the case of a visiting pharmacist from another relevant state, paragraph (1)(g) shall be replaced by a statement that the person is a “visiting pharmacist from another relevant state entitled to provide the services of a registered pharmacist on a temporary and occasional basis”.

(3) Paragraph (1)(g) shall come into effect on January 1st 2010.

Requirement for and format of certificates of registration for pharmaceutical assistants

14. (1) As soon as practicable after a person’s name has been entered in or restored to the Register of Pharmaceutical Assistants, the Council shall issue a certificate of registration to that person.

(2) On continuing the registration of a pharmaceutical assistant the Council shall issue a certificate of continued registration to that person.

(3) A certificate of registration issued to a pharmaceutical assistant is current for a period of 12 months from the date of registration or restoration and in the case of continued registration, the certificate shall be current for the period of 12 months beginning with the day following the date of expiry of the immediately preceding certificate.

(4) A certificate of registration issued pursuant to this Rule, shall be designed in a format and manner which would reasonably be expected to prevent forgery, impersonation or unauthorised duplication and shall contain at least the following information-

(a) the person’s name as it appears in the Register of Pharmaceutical Assistants,

(b) the person’s registration number,

(c) the number of the certificate of registration which shall be a number unique to that certificate,

(d) the date of expiry of the certificate of registration,

(e) the date of issue of the certificate of registration,

(f) a photograph of the person affixed to the certificate in a manner which, in so far as practical, is tamper-proof; and

(g) a statement to the effect that the certificate be displayed, or kept readily available for inspection, at the place of practice, as may be required.

(5) Paragraph (4)(f) shall come into effect on January 1st 2010.

Format of certificates of registration for a retail pharmacy business

15. A certificate of registration issued, pursuant to Section 20 of the Act, in respect of a registered retail pharmacy business shall be designed in a format and manner which would reasonably be expected to prevent forgery, impersonation or unauthorised duplication and shall contain at least the following information-

(a) the name of the pharmacy owner;

(b) the business name of the pharmacy;

(c) the full postal address of the pharmacy premises;

(d) the registration number in the Register of Retail Pharmacy Businesses;

(e) the number of the certificate of registration which shall be a number unique to that certificate;

(f) the date of issue of the certificate of registration; and

(g) the date of expiry of the certificate of registration.

PART 5 REMOVAL FROM REGISTERS

Removal of Registration for failure to make application for continued registration

16. (1) Where a registrant has failed to apply for continued registration the Registrar shall, within 14 days of the last date for the receipt of the application for continued registration, issue a letter to the registrant, by way of a reminder of the need to make such an application.

(2) In the event that the registrant has not made application for continued registration and its associated certificate of continued registration by the date on which such registration and issue of the relevant certificate of registration should have been made, the Registrar shall, after the expiry of 14 days from that date, send a letter by ordinary pre-paid post, as a first demand that the required application for continued registration be made forthwith.

(3) In the absence of an application as aforesaid, the Registrar shall forthwith after the expiry of 14 days from the date of the first demand, send by registered post or other method of recorded delivery, a final demand that the required application for continued registration be made and advising that-

(a) no further warning will be given, and

(b) failure to make such application within 14 days of the date of the final demand will result in removal of registrant’s name from the relevant register.

(4) In the absence of receipt of an application for continued registration within 14 days of the date of the final demand, the Registrar shall cancel the registration, remove the name from the relevant register and advise the person concerned accordingly.

(5) In this Rule, where a letter is to be sent to a registrant, such letter shall be sent to the published address or to such other address as may have been notified by the registrant to the Registrar as being the address at which such person resides.

Removal of registration for failure to pay a fee

17. (1) Where a registrant has failed to pay a retention fee or a fee for recording a change in the relevant Register, the Registrar shall, within 14 days of the date on which the relevant fee was due, send a letter by ordinary pre-paid post, as a first demand requesting that the relevant fee be paid.

(2) In the absence of payment of the relevant fee, the Registrar shall after the expiry of 14 days from the date of the first demand, send by registered post or other method of recorded delivery, a final demand that the relevant fee be paid and advising that-

(a) no further warning will be given, and

(b) failure to pay such fee within 14 days of the date of the final demand will result in removal of registrant’s name from the relevant register.

(3) In the absence of receipt of the relevant fee within 14 days of the date of issue of the final demand, the Registrar shall cancel the registration, remove the name from the relevant register and advise the person concerned accordingly.

(4) In this Rule, where a letter is to be sent to a registrant, such letter shall be sent to the published address or to such other address as may have been notified by the registrant to the Registrar as being the address at which such person resides.

PART 6 THIRD COUNTRY QUALIFICATIONS AS PHARMACISTS

Recognition of third country qualifications as qualifications appropriate for practice

18. (1) Subject to the provisions of this Rule, the Council may recognise as a qualification appropriate for practice in the State, qualifications as a pharmacist obtained in a country that is not a relevant state, provided that such recognition respects the minimum training conditions laid down in Article 44 of the Professional Qualifications Directive.

(2) Where the Council receives an application under this Part from a person holding a qualification as a pharmacist obtained in a country that is not a relevant state and it appears to the Council that such qualification may conform to the minimum training conditions referred to in paragraph (1), the Council shall-

(a) so as to inform itself about the standard of training, education, examinations and qualifications obtained by the applicant in acquiring his or her qualification as a pharmacist, require the applicant to complete an examination prescribed by the Council. Such examination shall also take into account any other relevant training undergone or experience gained;

(b) where it has any doubt about a matter relating to the standard of training, education, examinations and qualifications obtained by the applicant in acquiring his or her qualification as a pharmacist, require the person to complete an adaptation period, which shall be not less than six months in duration; and

(c) require such person to pass the Professional Registration Examination.

(3) Where a person has satisfactorily completed the requirements set out in paragraph (2), the person shall be regarded as having a qualification appropriate for practice in the State and the Council shall issue an appropriate certificate to the applicant to that effect.

Applications for recognition of third country qualifications as qualifications appropriate for practice

19. (1) Every application for recognition of a qualification as a pharmacist obtained in a country other than a relevant state shall be made in writing to the Registrar, on a form provided by the Council and shall be signed by the person making the application.

(2) Every such application shall contain or be accompanied by-

(a) the particulars specified in Schedule 4, and

(b) any fee that may be payable in connection with that application.

(3) Where the Council considers it necessary, it shall be entitled to require-

(a) verification of anything contained in the application,

(b) verification of the level of the applicant’s qualification as a pharmacist on the National Qualifications Framework or such other framework as may for the time being be in use in the State, or

(c) the supply of further information in relation to the application.

Rule 11(2)

SCHEDULE 1 Particulars to be contained in or to accompany an application for registration in Part A of the Register of Pharmacists

1. The name of the applicant as it appears on his or her birth certificate or current passport.

2. The address at which the person ordinarily resides.

3. Where known at the time of application, the address at which the person intends to practise as a pharmacist.

4. The applicant’s contact details, including a telephone number and an electronic mail address, where available.

5. The applicant’s date and place of birth.

6. The titles of the applicant’s qualifications in pharmacy, including the names and addresses of the awarding bodies and dates of award of those qualifications.

7. The application shall be accompanied by-

(a) a copy of the applicant’s birth certificate,

(b) evidence of the applicant’s identity in the form of-

(i) a copy of his or her passport, or in default, such other document as may be considered acceptable for the purpose by the Registrar, and

(ii) a recent photograph which is signed and dated by a registered legal or health care professional who certifies that the photograph is of the applicant and is a true likeness of him or her.

8. Where the applicant, not being a national of a relevant state, seeks to rely on rights acquired by virtue of an enforceable Community right, he or she shall provide a copy of his or her current valid residence card issued by the Minister for Justice, Equality and Law Reform under the European Communities (Free Movement of Persons) (No. 2) Regulations 2006 ( S.I. No. 656 of 2006 ) (as amended) and such card shall be made available to the Registrar for inspection.

9. The application shall also be accompanied by documentary evidence that the applicant holds a qualification appropriate for practice. Such evidence shall consist of-

(a) in the case of an applicant who has acquired his or her qualification appropriate for practice in the State, evidence to show that he or she has completed a relevant degree in pharmacy and the required period of practical training and that he or she has passed the required Professional Registration Examination.

(b) in the case of an applicant who is a national of a relevant state and who holds a qualification as a pharmacist obtained in any such state, evidence to show that he or she-

(i) holds a qualification to which Article 21 (automatic recognition) of the Professional Qualifications Directive refers, or

(ii) holds a qualification entitling him or her to acquired rights as provided for in Article 23 of the Professional Qualifications Directive,

and which is supported by-

(aa) a certificate issued by the competent authority in the applicant’s home relevant state, confirming that the evidence of formal qualification as a pharmacist is that covered by the Professional Qualifications Directive, and

(bb) in the case of an applicant availing of Article 23, paragraphs 1 to 5, of that Directive, is accompanied by a certificate, issued by the competent authority of the relevant state, stating that the applicant has been effectively and lawfully engaged in the professional activities of a pharmacist for at least three consecutive years during the five years preceding the award of the certificate, and

(cc) in the case of an applicant availing of Article 23, paragraph 6, of that Directive, is accompanied by a certificate, issued by the competent authority of the relevant state, stating that the applicant’s evidence of formal qualifications certifies successful completion of training in accordance with Article 44 of that Directive and is treated by the relevant state which issued it in the same way as the qualifications listed in Annex V, point 5.6.2, of that Directive.

(c) in the case of an applicant who is a national of a relevant state who holds a formal qualification as a pharmacist which does not meet the requirements of effective and lawful professional practice but who is not in a position to provide a certificate required under paragraph (b) above only because he or she has not been engaged in the activities of a pharmacist for at least 3 consecutive years during the 5 years preceding the date of his or her application, a statement setting out the experience acquired by the applicant in practice as a pharmacist, so as to enable the Council to evaluate the need for an adaptation period and the nature and duration of such period.

(d) in the case of an applicant who is a national of a relevant state and who holds a qualification as a pharmacist obtained in a country other than a relevant state, which has been recognised in a relevant state other than the State-

(i) evidence to show that he or she holds a qualification obtained in a country other than a relevant state which has been recognised in a relevant state and which may under the Act be regarded as a qualification appropriate for practice;

(ii) evidence or confirmation that he or she has made arrangements for a certificate to be issued by the competent authority in the relevant state which has recognised the qualification concerned for the purpose of access to the professional activities of a pharmacist in that state. Such certificate shall also include confirmation that the applicant has satisfied the minimum training requirements specified in Article 44 of the Professional Qualifications Directive;

(iii) evidence or confirmation that he or she has made arrangements for a certificate to be issued by a competent authority in that state providing confirmation that the applicant concerned has experience of at least three years practising as a pharmacist in that state; and

(iv) a statement setting out the experience acquired by the applicant in practice as a pharmacist in the relevant state and in the other country concerned, to enable the Council to evaluate the need for an adaptation period and the nature and duration of such period.

(e) in the case of an applicant who is not a national of a relevant state and who holds a qualification as a pharmacist obtained in a country other than a relevant state, a certificate issued to the applicant under Rule 18(3) stating that the applicant has been regarded as having a qualification appropriate for practice in the State.

10. The application shall be accompanied by-

(a) a certificate completed by the applicant’s medical practitioner attesting that he or she is not aware of any reason on grounds of physical or mental health why the applicant might be unable to discharge the responsibilities of a registered pharmacist;

(b) in the case of an applicant who has qualified, or has practised, as a pharmacist outside the State, a certificate of good standing or of current professional status issued, no more than three months prior to the date of the application, by the appropriate authority of the country in which the pharmacist qualified or was practising or by the appropriate authority of every country in which the pharmacist has practised in the five years immediately preceding the date of application;

(c) a statutory declaration which declares that-

(i) the applicant is the person to whom the various certificates and documents presented refer;

(ii) any facts, dates and circumstances contained within those certificates and documents are, to his or her knowledge, true and accurate; and

(iii) the certificates and documents concerned, where presented in copy form, are true and accurate copies of the originals.

(d) a statutory declaration by the applicant attesting to his or her good character or repute, in a form published by the Council from time to time, stating that, by virtue of his or her education and training, he or she is aware of the legal, moral and ethical principles which govern the profession of pharmacist in the State and that he or she has read, understood and agrees to abide by the Code of Conduct for Registered Pharmacists as published by the Society from time to time;

(e) a statutory declaration by the applicant attesting that he or she has not, under the law of another state, been prohibited from carrying on any activity in that state corresponding to the practice of a pharmacist or the carrying on of a retail pharmacy business, or convicted in the State or another state of an offence the nature of which has, in the opinion of the Council, a bearing on the person’s fitness to practise;

(f) a statutory declaration by the applicant attesting that he or she has not, under the law of the State or another state, been prohibited from carrying on any other practice, profession or occupation appearing to the Council to consist, or mainly to consist, of the provision of health care or services or social care or services;

(g) a statutory declaration by the applicant attesting that he or she is not an undischarged bankrupt;

(h) in the case of an applicant who is not a national of a relevant state, a certificate issued by an internationally recognised body or authority, recognised by the Council, attesting that the holder has attained a standard of competence in the English, or Irish language, sufficient to enable him or her to safely communicate with, and to treat, patients and to generally discharge his or her professional obligations as a pharmacist in the State; and

(i) in the case of an applicant who is a national of a relevant state-

(i) where he or she considers that he or she has sufficient competence in the English, or Irish language, necessary to discharge his or her professional obligations as a pharmacist, a statutory declaration to that effect, or

(ii) where he or she considers that he or she lacks that competence, a statutory declaration attesting that he or she undertakes to acquire it.

Rule 11(4)

SCHEDULE 2 Particulars to be contained in or to accompany an application for continued registration in Part A of the Register of Pharmacists

1. The name of the applicant and address at which he or she ordinarily resides.

2. The address at which the applicant practises his or her profession as a pharmacist or, where the applicant does not currently have a fixed practice address or is not currently practising, a statement to either effect whichever is appropriate.

3. The professional capacity as a pharmacist in which he or she is practising, where appropriate.

4. The applicant’s contact details, including a telephone number and electronic mail address, where available.

5. In the case of an application where there has been no change in the particulars supplied in respect of the applicant’s outgoing registration, a statement, in the form set out by the Council from time to time, to the effect that no change has been made to the particulars concerned.

6. In the case of an application where there has been a change in his or her circumstances since the applicant’s application for the outgoing registration was made, a statement of each such change in the format required in Schedule 1.

7. A statement setting out how the applicant ensures that he or she-

(a) maintains appropriate experience in the practice of pharmacy, and

(b) keeps abreast of continuing education and continuing professional developments in the profession of pharmacy.

8. A recent photograph of the applicant.

Rule 12(2)

SCHEDULE 3 Particulars to be contained in or to accompany an application for continued registration in the Register of Pharmaceutical Assistants

1. The name of the applicant and address at which he or she ordinarily resides.

2. The address at which the applicant practises his or her profession, or where the applicant is not currently practising, a statement to that effect.

3. The applicant’s contact details, including a telephone number and electronic mail address, where available.

4. In the case of an application where there has been no change in the applicant’s circumstances-

(a) as entered in the Register of Assistants to Pharmaceutical Chemists kept pursuant to the Pharmacy Act (Ireland) Act 1875 (as amended), or

(b) since his or her application for the outgoing registration was made,

a statement to the effect that no change has been made to the information that was contained in the said Register or, as the case may be, that was then supplied.

5. In the case of an applicant where there has been a change in his or her circumstances as described in paragraph (3), a statement of each such change.

6. A recent photograph of the applicant.

Rule 19

SCHEDULE 4 Particulars to be contained in or to accompany an application for recognition of a third country qualification as a qualification appropriate for practice

1. The name of the applicant.

2. The address at which the applicant ordinarily resides.

3. The applicant’s contact details, including a telephone number and electronic mail address, where available.

4. The applicant’s nationality.

5. Details of the applicant’s qualifications as a pharmacist in the country concerned.

6. Details of the theoretical and practical training, including the completion of any period of in-service training, undertaken in order to obtain the relevant qualification as a pharmacist.

7. Details of any other country in which the applicant has made application for recognition of his or her qualifications as a pharmacist and the outcome of such application.

8. Details of any other country in which the applicant’s qualification as a pharmacist is or was recognised to practise as a pharmacist or to operate a pharmacy.

9. Details of the applicant’s professional experience as a pharmacist including the nature, scope and duration of such experience.

10. The form of application shall be accompanied by-

(a) a copy of the applicant’s birth certificate,

(b) evidence of the applicant’s identity in the form of-

(i) a copy of his or her passport or, in default, such other document as may be considered acceptable for the purpose by the Registrar, and

(ii) a recent photograph which is signed and dated by a registered legal or health care professional who certifies that the photograph is of the applicant and is a true likeness of him or her,

(c) a certified copy of the applicant’s qualification as a pharmacist in the country in which the said qualification was obtained,

(d) the detailed syllabus issued by the educational institution at which the applicant undertook any programmes of education and training for the purpose of obtaining his or her initial qualification as a pharmacist in the country in which the said qualification was obtained,

(e) a statement of any other programmes of education and training, qualifications or recognition of the applicant’s qualification as a pharmacist in any other country that he or she may consider relevant to his or her application,

(f) a certificate from the competent authority in the country in which qualification as a pharmacist was obtained, certifying that the applicant holds the qualification of a pharmacist and that he or she is lawfully entitled to practise as a pharmacist in that country, and

(g) a statutory declaration which declares that-

(i) the applicant is the person to whom the various certificates and documents presented refer;

(ii) any facts, dates and circumstances contained within those certificates and documents are, to his or her knowledge, true and accurate; and

(iii) the certificates and documents concerned, where presented in copy form, are true and accurate copies of the originals.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Rules set out the information which is to be recorded in the Register of Pharmacists, the Register of Druggists, the Register of Pharmaceutical Assistants and in the Register of Retail Pharmacy Businesses.

The Rules also set out the prescribed requirements for first registration and for continued registration in the Register of Pharmacists, as well as the prescribed requirements for registration in the Register of Pharmaceutical Assistants.

These Rules also set out the format of certificates of registration for pharmacists, pharmaceutical assistants and for retail pharmacy businesses.

Procedures for the removal of registrants from the Registers for failure to apply for continued registration and for failure to pay fees are set out in the Rules. The Rules also set out the procedures for the recognition of third country qualifications in pharmacy as qualifications appropriate for practice in the State.