Pharmaceutical Society of Ireland (Education and Training) (Integrated Course) Rules 2014

• Jurisdiction: Ireland
• Citation: IR SI 377/2014
• Year: 2014

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 12th August, 2014.

PART 1

GENERAL PROVISIONS

Citation

1. These Rules may be cited as the Pharmaceutical Society of Ireland (Education and Training) (Integrated Course) Rules 2014.

Commencement

2. These Rules come into operation on 1 June 2015.

Interpretation

3. 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 ), the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 (No. 24 of 2010), the European Communities (Recognition of Professional Qualifications relating to the Profession of Pharmacist) Regulations 2012 ( S.I. No. 235 of 2012 ), the European Communities (Recognition of Professional Qualifications relating to the Profession of Pharmacist) Regulations 2013 ( S.I. No. 377 of 2013 ) and the Health (Pricing and Supply of Medical Goods) Act 2013 (No. 14 of 2013);

“active drug substance” means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;

“Advisory Committee on Pharmaceutical Training” means the Committee established under Article 1 of Council Decision 85/434/EEC of 16 September 19851 ;

“Core Competency Framework for Pharmacists”, in respect of a person pursuing a qualification appropriate for practice, has the meaning assigned to it in Rule 5 and refers to such document which is for the time being in force;

“criteria” means the Accreditation Standards for the Five-Year Fully Integrated Masters Degree Programme in Pharmacy published under Rule 7 for the recognition and approval of five-year integrated programmes of education and training, leading to the award of a Masters degree in pharmacy and which are for the time being in force;

“marketing authorisation”, in respect of a medicinal product, has the meaning assigned to it in Regulation 4(1) of the Medicinal Products (Control of Advertising) Regulations 2007 ( S.I. No. 541 of 2007 );

“medical device” has the meaning assigned to it in section 1(1) (inserted by section 10 (c) of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995);

“medicinal product” has the meaning assigned to it in section 2 of the Act and includes veterinary medicinal products within the meaning of section 18(2) of the Act;

“qualification appropriate for practice” has the meaning assigned to it in section 16(1) of the Act as referred to in section 14(1)(e) of the Act, as being one of the requirements essential for registration in the Register of Pharmacists;

“recognised institution” means a university or other higher education institution in the State that is recognised by the State as having an equivalent status to that of a university;

“Register of Pharmacists” and “Register of Retail Pharmacy Businesses” mean the relevant registers established under section 13(1) of the Act;

“registered pharmacist” means a person whose name is entered in the Register of Pharmacists;

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

“training establishment” means any of the establishments referred to in Rule 14(1)(b) or in Rule 15(1);

“tutor pharmacist” means a registered pharmacist who has been recognised as a tutor pharmacist by the recognised institution under Rule 16.

Core Competency Framework for Pharmacists

4. (1) For the purposes of these Rules, the Council shall prepare, adopt and publish a framework document, which shall be known as the Core Competency Framework for Pharmacists.

(2) The Core Competency Framework for Pharmacists shall set out the competencies, including knowledge, skills, attitudes and values, that are to be attained by a person who has pursued the programmes of education and training referred to in Rule 7 leading to a qualification appropriate for practice.

(3) The content of the Core Competency Framework for Pharmacists shall be informed by the body of knowledge, the skills, and the values set out in the Schedule.

(4) The Council shall review and update the Core Competency Framework for Pharmacists at intervals not exceeding five years having regard to national and international advancements in the theory and practice of pharmacy and healthcare, including advancements in relevant scientific and technical progress, and national policy in the areas of healthcare practice, pharmacy, and in professional development and learning.

(5) Where the Council proposes to amend the Core Competency Framework for Pharmacists, it shall publish its proposals on the Society’s website and issue invitations to the relevant stakeholders to comment, within such reasonable period of time as specified by the Council, upon those proposals.

(6) The Council shall publish on the Society’s website the Core Competency Framework for Pharmacists.

PART 2

QUALIFICATIONS APPROPRIATE FOR PRACTICE FOR THE PURPOSES OF SECTION 16(1) OF THE ACT

Qualifications appropriate for practice

5. A person who in accordance with these Rules holds a Masters degree in pharmacy that is recognised and approved by the Council in accordance with Part 3 shall be regarded as holding a qualification appropriate for practice.

PART 3

RECOGNITION AND APPROVAL OF PROGRAMMES OF EDUCATION AND TRAINING LEADING TO THE AWARD OF A MASTERS DEGREE IN PHARMACY

Recognition and approval of Masters degrees in pharmacy

6. Subject to the provisions of these Rules and for the purpose of Rule 5, the Council may recognise a Masters degree in pharmacy as a qualification appropriate for practice if the course of study leading to such Masters degree commenced after the date of coming into force of these Rules, and the Masters degree attests to training of at least five years’ duration and incorporates—

(a) not less than four years of full-time theoretical and practical training at a recognised institution, and

(b) not less than twelve months of in-service practical training in accordance with Part 4,

and the said training (including the full-time theoretical and practical training and the in-service practical training) conforms to the criteria published under Rule 7.

Criteria for recognition and approval of five-year integrated programme of education and training leading to award of Masters degree in pharmacy

7. (1) The Council shall, for the purposes of this Part and in accordance with the procedures set out in this Rule, determine, approve and publish criteria for the recognition and approval of five-year integrated programmes of education and training, leading to the award of a Masters degree in pharmacy.

(2) The criteria referred to in paragraph (1) shall at least—

(a) set out minimum requirements relating to the delivery of the programme including long-term commitment, staffing, premises, facilities, funding, policies, procedures and organisational structures,

(b) incorporate, in an indicative syllabus, those subjects and branches of knowledge set out in the Schedule,

(c) incorporate the competencies set out in the Core Competency Framework for Pharmacists,

(d) incorporate a requirement to demonstrate a minimum standard of knowledge in relation to the legislation and the law pertaining to pharmacy and medicinal products, the practice of pharmacy in the State, the obligations deriving from professional registration, professional codes of conduct and the ethical principles expected of a person practising as a pharmacist in the State, and

(e) have regard to the National Framework of Qualifications kept and maintained in accordance with Section 43 of the Qualifications and Quality Assurance (Education and Training) Act 2012 (No. 28 of 2012).

(3) The Council shall review the criteria referred to in paragraph (1) at intervals not exceeding five years having regard to national and international advancements in the theory and practice of pharmacy and healthcare, including advancements in relevant scientific and technical progress, and national policy in the areas of healthcare practice, pharmacy, higher education and professional development and learning.

(4) Where the Council proposes to amend the criteria referred to in paragraph (1), it shall publish its proposals on the Society’s website and issue invitations to the relevant stakeholders to comment, within such reasonable period of time as specified by the Council, upon those proposals.

(5) The Council shall publish on the Society’s website the criteria adopted in accordance with this Rule, or as may subsequently be amended under this Rule.

Application for recognition of five-year integrated programme of education and training leading to award of Masters degree in pharmacy

8. (1) A recognised institution which proposes to offer a five-year integrated programme of education and training leading to the award of a Masters degree in pharmacy for the purpose of Rule 5, shall—

(a) make application in writing to the Registrar in the manner and form as may, from time to time, be prescribed by the Council, and

(b) satisfy the Council that the proposed programme of education and training and all matters relating to its delivery and processes of assessment, including staffing, premises, facilities, in-service practical training, funding and procedures, will conform with the criteria published under Rule 7.

(2) Subject to the provisions of this Rule, the Council shall consider an application received under paragraph (1) and shall...