STATUTORY INSTRUMENTS

S.I. No. 212 of 2002

Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 2002

DUBLIN

PUBLISHED BY THE STATIONERY OFFICE

S.I. No. 212 of 2002

Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 2002

The Council of the Pharmaceutical Society of Ireland in exercise of the powers conferred on it by sections 16 and 17 of the Pharmacy Act (Ireland), 1875 (38 & 39 VICT. Chap. 57.) and by sections 4, 5 and 6 of the Pharmacy Act, 1962 (No. 14 of 1962) , hereby makes the following Regulations:-

1.      These Regulations may be cited as the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 2002.

2.      These Regulations and the Regulations of the Pharmaceutical Society of Ireland, 1971 to 1995 shall be construed together and may be cited together as the Regulations of the Pharmaceutical Society of Ireland, 1971 to 2002.

3.       (1) In these Regulations:-

“Advisory Committee on Pharmaceutical Training” means the Committee established by virtue of the EU Council Decision of 16 September 1985¹ ;

“the Council” means the Council of the Pharmaceutical Society of Ireland;

“criteria” means the criteria adopted and published for the time being by the Council in accordance with article 10 for the purpose of:

(a) granting its recognition and approval of courses leading to a degree in pharmacy under article 5, and

(b) continuing to grant, its recognition and approval of courses leading to a degree in pharmacy under articles 7, 8 and 9;

“EU Council” means the Council of the European Communities;

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

“the Minister” means the Minister for Health and Children.

(2) In these Regulations, every reference to an article shall be construed as a reference to an article contained in these Regulations and any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

4.      The Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 1977 are hereby amended by -

(a) the substitution of the following paragraph for paragraph (b) of article 6:

“(b) complete a four year course of studies at an institution in the State leading to the award of a degree in pharmacy that has been recognised and approved by the Council under article 5 of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 2002 and pass the required examination for the award of such degree.”.

(b) the substitution of the following paragraph for paragraph (c) of article 7:

“(c) evidence that he has been admitted by an institution in the State as a student to a pharmacy degree course that has been recognised and approved by the Council under article 5 of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 2002.”.

5.       (1) An institution in the State that proposes to offer a course leading to a degree in pharmacy with a view to that degree being recognised and approved by the Council for the purpose of obtaining registration as a pharmaceutical chemist, shall -

(a)  make application in writing to the Registrar of the Society in the manner prescribed by the Council for the purpose of obtaining the recognition and approval of the Council for the proposed course leading to a degree in pharmacy;

(b) satisfy the Council that the proposed course leading to a degree in pharmacy meets the criteria.

(2)  The Council, on receipt of an application under sub-article (1) and on being satisfied that the proposed course leading to a degree in pharmacy meets the criteria, shall grant its recognition and approval for the said course.

6.        If, subsequent to granting recognition and approval to a course in an institution in accordance with article 5, the Council publishes criteria which amend or alter the criteria under which recognition and approval was granted, the said institution shall have regard to the amended or altered criteria in the provision of the said course.

7.        Where the Council has recognised and granted its approval under article 5 in respect of a degree in pharmacy to be awarded by an institution in the State, it shall publish a notice to that effect in Iris Oifigiúil and shall subsequently -

(a)  re-evaluate the course leading to the award of the degree at intervals not exceeding four years; and

(b) conduct such re-evaluation as aforesaid on the basis of the criteria and in the manner provided for in articles 8 and 9.

8.        (1)  For the purpose of article 7(a) and (b) the Council shall appoint persons to visit the institution concerned in consultation and in conjunction with the said institution. Hereinafter in this article such persons are referred to as visitors.

(2)  It shall be the duty of visitors to visit the institution as aforesaid and to report in writing to the Council as to whether or not the standard of compliance of the course in pharmacy being offered satisfies the criteria.

(3)  No person appointed as a visitor shall interfere with the giving of any instructions in the course of his visitation.

(4)  The visitors in their report to the Council on the institution concerned shall recommend that the Council:

(a)  continue to grant its recognition and approval for the course,

(b)  continue to grant its recognition and approval for the course subject to certain conditions that they shall specify,

(c)  defer its decision on the continued recognition and approval for the course pending the resolution, to the satisfaction of the Council, of certain matters of concern that they shall specify, or

(d) refuse to continue to grant its recognition and approval for the course and give its reasons for so doing.

9.        (1) The Council, on receipt of the report of the visitors under article 8, shall forthwith send a copy of the report to the institution concerned. Such institution may, within such period (not being less than one month) as the Council shall specify at the time it has sent the report to the institution, submit to the Council its comments and observations on the report.

(2) Subject to sub-article (3), on consideration of the report of the visitors as aforesaid and of any comments and observations received from the institution concerned, the Council may by resolution -

(a)  continue to grant its recognition and approval for the course,

(b)  continue to grant its recognition and approval for the course subject to certain conditions that it shall specify,

(c)  defer a decision on its continued recognition and approval for the course pending the satisfactory resolution of certain matters of concern that it shall specify, or

(d)  refuse to continue to grant its recognition and approval for the course and give its reasons for so doing.

(3) Where the Council proposes to adopt a resolution that would have the effect of refusing to continue to grant its recognition and approval for a particular course on the basis that the criteria are not being complied with to such an extent that it is considered that the course being offered at the institution is not such as would provide its graduates with the requisite knowledge and skills to practice pharmacy, the Council shall submit a report to that effect to the Minister and shall defer the adoption of the resolution until the approval of the Minister has been obtained.

(4) Where a resolution under sub-article (2)(d) is adopted by the Council, no person who is awarded a degree in pharmacy by the institution concerned shall be entitled to present for the pharmaceutical licence examination, or be entitled to registration as a pharmaceutical chemist, on the basis of a degree granted by the said institution after the date specified in the resolution.

(5)  If the Council is satisfied, on the basis of representations made by the institution concerned, that effective provision has been made for the necessary improvements of the course leading to the award of the degree in pharmacy, so as to comply with the criteria, the Council may, with the approval of the Minister, revoke the resolution to which sub-article (4) applies. Such revocation shall not entitle a person to be registered as a pharmaceutical chemist on the basis of a degree in pharmacy granted by the institution concerned during the period from the date specified in the resolution until the coming into force of the revocation of the resolution.

(6) Where recognition and approval of a course in pharmacy has been held by an institution in the State by virtue of the provisions of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 1977, such recognition and approval shall continue in force as if it were granted under article 5.

10.      (1) The Council in the adoption of the criteria for the granting of its recognition and approval of courses leading to a degree in pharmacy shall have regard to -

(a)  the minimum conditions for the award of diplomas, certificates or other formal qualifications in pharmacy as specified in points 1, 2, 3 and 5 of article 2 of EU Council Directive 85/432/EEC² ;

(b)  any recommendations that may be adopted from time to time by the Advisory Committee on Pharmaceutical Training on the education and training of pharmacists that is undergone at higher education institutions; and

(c)  the minimum conditions of qualification specified in paragraph (2) of article 49 of Directive 2001/83/EC³ .

(2)  The Council shall on a regular basis review and, as necessary, amend the criteria referred to in sub-article (1) to take account of scientific and other developments in the practice of the profession of pharmacy.

(3)  The Council shall publish and make available for sale the criteria adopted or as subsequently amended under this article.

11.       In article 8 of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 1977 (as substituted by article 5 of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 1988 and as amended by article 3 of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations 1995), every reference to the degree Bachelor of Science (Pharmacy) shall be construed as being a reference to a degree in pharmacy obtained after successful completion of a course that under these Regulations has been recognised and approved by the Council.

12.      (1) The financial year of the Society shall be the period of twelve months ending on the 31^st day of December in any year.

(2)  The Council shall cause to be kept proper accounts of all income and expenditure of the Society, and of the sources of such income and the subject matter of such expenditure, and of the property, credits and liabilities of the Society.

(3)  A statement of accounts of the Society for the financial year shall, as soon as possible after the end of such financial year, be prepared and after such preparation be audited by and be subject to a report by an auditor appointed for the purpose by the Council.

(4)  A copy of the accounts and of the auditor's certificate and report thereon shall be presented to the members of the Council and subsequently to the membership of the Society in attendance at the annual meeting.

(5)  The Council shall by resolution determine the procedure for the making of payments on behalf of the Society and, in that regard, the Council shall

authorise persons who may on behalf of the Council act as signatories in the making of such payments.

(6)  The “treasurer's alphabetical lists” referred to in article 4 of the Regulations of the Pharmaceutical Society of Ireland, 1971 shall be the alphabetical lists prepared by the Registrar for the purposes set out in the said article 4.

13.       Articles 22, 23, 24 and 27 of the Regulations of the Pharmaceutical Society of Ireland, 1971 and article 10 of the Regulations of the Pharmaceutical Society of Ireland (Amendment) Regulations, 1977 are hereby revoked.

14.       The Regulations of the Pharmaceutical Society of Ireland, 1971 are hereby amended by the substitution of the following for article 13:

“13. The Council shall hold at least four meetings in the course of its financial year, in such month and day and at such time as may from time to time be decided by the Council. Further meetings of the Council shall be held as may be necessary for the performance of its functions. Such further meetings shall be held as are notified by the Registrar upon the direction of the President (or in his absence, the Vice-President) and giving each member of the Council four clear days notice of the day and time of the meeting and of the business to be transacted.”

The Minister for Health and Children approves of the above Regulations.

¹ Official Journal of the European Communities No L253, 24.09.85, p43.

² Official Journal of the European Communities No L.253, 24.09.85, p34

³ Official Journal of the European Communities No L.311, 28.11.2001, p67