European Communities (Recognition of Professional Qualifications Relating to the Profession of Pharmacist) (No. 2) Regulations, 2008

• Jurisdiction: Ireland
• Citation: IR SI 489/2008
• Year: 2008

S.I. No. 489 of 2008

EUROPEAN COMMUNITIES (RECOGNITION OF PROFESSIONAL QUALIFICATIONS RELATING TO THE PROFESSION OF PHARMACIST) (NO. 2) REGULATIONS 2008

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 2nd December, 2008.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive 2005/36/EC 1 as amended by Directive 2006/100/EC 2 , (insofar as those Directives concern the profession of pharmacist), hereby make the following Regulations:

PART 1 GENERAL PROVISIONS

Citation

1. These Regulations may be cited as the European Communities (Recognition of Professional Qualifications relating to the Profession of Pharmacist) (No. 2) Regulations 2008.

Commencement

2. These Regulations shall come into operation on 29th November 2008.

Interpretation

3. (1) In these Regulations—

‘Council’ means the Council established by section 10 of the Pharmacy Act 2007 (No. 20 of 2007);

‘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 accession of Bulgaria and Romania.

(2) In these Regulations, words and phrases shall have the same meaning as in the Professional Qualifications Directive.

(3) In these Regulations, unless the context otherwise requires, any reference to a Regulation shall be construed as a reference to a Regulation contained in these Regulations and any reference in a Regulation to a paragraph shall be construed as a reference to a paragraph in that Regulation.

PART 2 AMENDMENTS TO PHARMACY ACT 2007

4. Section 16(4) of the Pharmacy Act 2007 is substituted by the following—

“(4) The second of those requirements is that—

(a) the person provides evidence—

(i) that he or she holds a formal qualification as a pharmacist which does not satisfy all the training requirements referred to in Article 44 of the Professional Qualifications Directive, but attests successful completion of training which began before—

(I) the relevant reference date laid down in Annex V, point 5.6.2, in the case of a qualification issued by a Member State of the European Union, or

(II) 3 October 1990, in the case of a qualification obtained in the territory of the former German Democratic Republic,

and is accompanied by a certificate, issued by the competent authority of a relevant state, stating that the person, being the holder of formal qualifications as a pharmacist, has been effectively and lawfully engaged in the activities in question for at least three consecutive years during the five years preceding the award of the certificate; or

(ii) that he or she holds a formal qualification as a pharmacist issued by the former Czechoslovakia, or that his or her training commenced, for the Czech Republic and Slovakia, before 1 January 1993, where the authorities of either of the two aforementioned Member States attest that such evidence of formal qualifications has the same legal validity within their territory as the evidence of formal qualification which they issue as regards access to the professional activities of a pharmacist, as referred to in Article 45(2) of the Professional Qualifications Directive, and the pursuit of such activities; or

(iii) that he or she holds a formal qualification as a pharmacist issued by the former Soviet Union, or that his or her training commenced—

(I) for Estonia, before 20 August 1991,

(II) for Latvia, before 21 August 1991,

(III) for Lithuania, before 11 March 1990,

where the authorities of any of the three aforementioned Member States attest that such evidence of formal qualifications has the same legal validity within their territory as the evidence of formal qualification which they issue in respect of access to the professional activities of a pharmacist, as referred to in Article 45(2) of the Professional Qualifications Directive, and the pursuit of such activities; or

(iv) that he or she holds a formal qualification as a pharmacist issued by the former Yugoslavia, or that his or her training commenced, for Slovenia, before 25 June 1991, where the authorities of that Member State attest that such evidence of formal qualifications has the same legal validity within their territory as the evidence of formal qualification which they issue in respect of access to the professional activities of a pharmacist, as referred to in Article 45(2) of the Professional Qualifications Directive, and the pursuit of such activities; or

(v) that he or she holds a formal qualification as a pharmacist which does not correspond to the titles given for the relevant Member State in Annex V, point 5.6.2, of the Professional Qualifications Directive, but is accompanied by a certificate issued by the competent authority or body in that Member State stating that the evidence of formal qualifications certifies successful completion of training in accordance with Article 44 of the Professional Qualifications Directive and is treated by the Member State in the same way as the qualifications whose titles are listed in Annex V, point 5.6.2, of that Directive,

and

(b) in the case of an application for registration pursuant to subparagraphs (ii), (iii) and (iv) of paragraph (a) of this subsection, the attestation from the authorities of the relevant Member State is accompanied by a certificate issued by those authorities stating that the person has been effectively and lawfully engaged in the activities of a pharmacist within their territory for at least three consecutive years during the five years prior to the date of issue of the certificate.”.

5. Section 16(5) of the Pharmacy Act 2007 is substituted by the following—

“(5) The third of those requirements is the person provides evidence that—

(a) he or she holds—

(i) a formal qualification as a pharmacist which does not meet the requirements of effective and lawful professional practice referred to in subsection (4), but has completed an adaptation period as may have been required by the Council having regard to Article 14, paragraphs (1), (4) and (5), of the Professional Qualifications Directive, or

(ii) a formal qualification as a pharmacist granted by a competent authority of a third country, which has been recognised by a competent authority in another relevant state for the purpose of access to the professional activities of a pharmacist as referred to in Article 45(2) of the Professional Qualifications Directive including the pursuit of such activities in that state, and who has experience of at least three years practising as such in that state certified in accordance with Article 3(3) of the said Directive,

and

(b) in the case of an application for registration pursuant to subparagraph (ii) of paragraph (a) of this subsection, the person—

(i) possesses the attestation of competence or evidence of formal qualification as a pharmacist required by a competent authority in another relevant state in order to gain access to and pursue the professional activities of a pharmacist in that state, as referred to in Article 45(2) of the Professional Qualifications Directive;

(ii) in the initial recognition by the competent authority of the other relevant state, has satisfied the minimum training requirements specified in Article 44 of the Professional Qualifications Directive; and

(iii) has completed an adaptation period, as may be required by the Council having regard to Article 14, paragraphs (1), (4) and (5), of the Professional Qualifications Directive.

6. Section 16(8) of the Pharmacy Act 2007 is amended—

(a) by inserting the following before the definition of “competent authority”:

“‘adaptation period’ means a period of pursuit of the profession of pharmacist in the State under the supervision of a registered pharmacist;”;

(b) by inserting the following after the definition of “competent authority”:

“‘national of a relevant state’ includes a person who is not a national of a relevant state, but who is, by virtue of any enforceable Community right, entitled to be treated no less favourably than a national of such a state;”;

(c) by removing the words “(other than the State)” from subparagraph (a) in the definition of “relevant state”;

(d) by removing the words “or the State” from the definition of “third country”.

7. Section 16 of the Pharmacy Act 2007 is amended by inserting the following new subsection after subsection (9)—

“(10) Where an adaptation period is required by the Council pursuant to Article 14 of the Professional Qualifications Directive—

(a) the adaptation period shall be set having regard to the professional knowledge of the applicant and shall not exceed a period of 3 years;

(b) the Council shall determine the detailed rules of the adaptation period, having regard to the circumstances of each individual applicant and, in particular, to the fact that he or she is a qualified pharmacist in another relevant state;

(c) the Council may, in circumstances where it considers it necessary to do so, require the applicant to undergo further training during the adaptation period; and

(d) the applicant’s performance during the adaptation period shall be assessed by the Council with the aim of assessing the ability of the applicant to pursue the profession of pharmacist in the State.”.

8. The Pharmacy Act 2007 is amended by inserting the following new section after section 21—

“Appeal against failure to make a determination

21A (1) An applicant whose application for registration under this Act is required to be, but is not, the subject of a determination by the Council within a set time...