S.I. No. 539/2007 - Medicinal Products (Control of Manufacture) Regulations 2007

• (a) in response to an order, or in anticipation of an order, which satisfies the requirements of paragraph 2 of Schedule 1 to those Regulations; and

• (b) where the conditions set out in subparagraphs (2) to (9) are complied with.

• (2) The authorisation holder shall, in the case of each importation of an exempt medicinal product, make, and keep available for inspection by officers of the Board, for a period of not less than five years, written records showing the following particulars—

• (a) the name of the medicinal product, being the brand name or the common name, or the scientific name, and any name, if different, under which the particular medicinal product is to be sold or supplied in the State;

• (b) the dosage form;

• (c) the trading style or name of the manufacturer of the medicinal product;

• (d) in respect of each active constituent of the medicinal product, any international non-proprietary name or the monograph name or, where that constituent does not have an international non-proprietary name, the accepted scientific name or any other name descriptive of the true nature of that constituent;

• (e) the quantity of medicinal product which has been imported;

• (f) the batch number of the medicinal product which has been imported; and

• (g) the name and address of the manufacturer of that medicinal product in the form in which it was imported and, if the person who supplied the medicinal product for importation is not the manufacturer, the name and address of such supplier.

• (3) Where the authorisation holder sells or supplies an exempt medicinal product, he or she shall, in addition to those records mentioned in sub-paragraph (2), make and maintain written records relating to—

• (a) the batch number of the batch of the product from which each sale or supply was made;

• (b) details of any suspected adverse reaction to the product so sold or supplied of which he or she becomes aware; and

• (c) details of any quality defect relating to the product so sold or supplied of which he or she becomes aware.

• (4) The authorisation holder shall not issue any advertisement, catalogue, price list or circular relating to the exempt medicinal product or make any representations in respect of that product.

• (5) The authorisation holder shall inform the Board forthwith of any matter, including suspected adverse reactions and quality defects, coming to his or her attention, in respect of an exempt medicinal product imported by him or her.

• (6) The authorisation holder shall cease importing or supplying an exempt medicinal product if he or she has received a notice in writing from the Board directing that, as from a date specified in that notice, a particular product or class of products shall no longer be imported or supplied.

• (7) The authorisation holder shall, on being informed by the Board, or by the manufacturer or person who supplied the medicinal product for importation, that the medicinal product can not be regarded either as a product which can safely be administered to human beings or as a product which is of satisfactory quality or efficacy for such administration, immediately withdraw any supplies of that product held by him or her and immediately recall all supplies already sold or distributed.

• (8) With effect from the 1 January 2008, the authorisation holder shall, not later than seven days of his or her importation of an exempt medicinal product, notify the Board of each such importation. Each such notification shall include the particulars set out in subparagraph (2).

• (9) With effect from the 1 January 2009, the notifications referred to in subparagraph (8) shall, except in exceptional circumstances, be communicated electronically to the Board and within a timeframe of two working days from the date of each such importation.

• (10) In this paragraph—

‘common name’ means the international non-proprietary name, or, if one does not exist, the usual common name;

‘international non-proprietary name’ means the international non-proprietary name recommended by the World Health Organisation; and

‘monograph name’ means the name or approved synonym which appears at the head of a monograph in the current edition of the European Pharmacopoeia or the British Pharmacopoeia, or a foreign or international compendium of standards and ‘current’ in this definition means current at the time the notice is sent to the Board.

[Regulations 8(4), 11(7) and 12(3)]

SCHEDULE 4 Procedural provisions relating to proposals to grant subject to the carrying out of certain obligations, proposals to grant otherwise than in accordance with the application, proposals to refuse to grant or vary, proposals to make the authorisation conditional on the carrying out of certain obligations, and proposals to suspend, vary or revoke a manufacturer’s authorisation

‘authorisation’ means a manufacturer’s authorisation; and

‘time allowed’ means the period of 28 days or such extended period as the Board may in any particular case allow.

• (a) not to grant an authorisation,

• (b) to grant an authorisation subject to the carrying out of certain obligations,

• (c) to grant an authorisation other than in accordance with the application,

• (d) to revoke, vary or suspend an authorisation,

• (e) not to vary an authorisation on the holder’s application to vary, or

• (f) to make an authorisation conditional on the carrying out of certain obligations,

the Board shall notify the applicant or authorisation holder accordingly.

• (a) a statement of the proposals of the Board;

• (b) a statement setting out in detail the reasons on which the said proposals are based, and

• (c) a statement that the applicant or authorisation holder has the right to make representations to the Board in response to the notification.

• (2) If, after the aforementioned suspension has taken effect, it appears to the Board that the authorisation should be further suspended or revoked, the Board shall proceed in accordance with the provisions of paragraphs 2 to 5.

[Regulations 3(1) and 13]

SCHEDULE 5 Requirements applicable to qualified persons

A person shall only have the capacity to act as a qualified person if he or she fulfils the conditions of qualification at one of (a), (b) or (c) below—

• (a) He or she is in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by the Board, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However, a university course of shorter duration may suffice if either of the conditions set out in clause (i) or (ii) are satisfied—

• (i) The minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level;

• (ii) Where two university courses or two courses recognised by the State in question as equivalent co-exist in an EEA State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognised equivalent shall be considered to fulfil the condition of duration referred to at clause (i) above insofar as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognised as equivalent by the State in question.

Where qualification is dependent on clause (i) or (ii), it must be shown that the course included theoretical and practical study bearing upon at least the following basic subjects:

Experimental physics,

General and inorganic chemistry,

Organic chemistry,

Analytical chemistry,

Pharmaceutical chemistry including analysis of medicinal products,

General and applied biochemistry (medical),

Physiology,

Microbiology,

Pharmacology,

Pharmaceutical technology,

Toxicology,

Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).

Studies in these subjects should be balanced so as to enable the person concerned to fulfil the obligations specified in Regulation 13.

Where a qualification under paragraph (a) is not dependent on clause (i) or (ii), the Board shall ensure that the person in question provides evidence of adequate knowledge of the aforementioned basic subjects.

All persons qualifying under this paragraph shall have acquired practical experience over at least two years, in one or more undertakings which are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.

• (b) He or she has engaged in the activities of a qualified person from the time of the application of Council Directive 75/319/EEC ¹⁵ in an EEA State without complying with the requirements of paragraph (a).

15 OJ No. L 147, 9.6.1975, p. 13.

• (c) He or she is the holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course — or a course recognised as equivalent by the Board — in a scientific discipline allowing him or her to engage in the activities of a qualified person, may- if he or she began his or her course before 21 May 1975 — be considered as qualified to carry out within the State the duties of a qualified person provided that he or she has previously engaged in the following activities for at least two years before 21 May 1985 at one or more undertakings authorised to manufacture medicinal products: production supervision and/or qualitative and quantitative analysis of active substances and the necessary testing and checking under the direct authority of a qualified person to ensure the quality of the medicinal products.

If the person concerned has acquired this practical experience before 21 May 1965, a further one year’s practical experience of this kind will be required to be completed immediately before such person may act as a qualified person for the purposes of these Regulations.

GIVEN under the Official Seal,

20 July 2007

MARY HARNEY.

Minister for Health and Children.

EXPLANATORY NOTE.

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

The main purpose of these Regulations is to implement TITLE IV of Directive 2001/83/EC (as amended by Directive 2004/27/EC) relating to the manufacture and importation of medicinal products for human use.

The Regulations also implement Article 13 of Directive 2001/20/EC and Chapter 3 of Directive 2005/28/EC, which relate to the manufacture and import of investigational medicinal products. The Regulations also fully implement Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use.

The Regulations also consolidate all the controls relating to the manufacture of medicinal products and investigational medicinal products into one set of Regulations.

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