The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 3) Regulations 1977

Amendment of Schedule 2 to the principal regulations

3.  Schedule 2 to the principal regulations (standard provisions for manufacturer's licences) shall be amended as follows—

(a)in paragraph 7(b) after the word “assembled” there shall be inserted the words “including the person named as the qualified person for the purposes of paragraph 16 of this Part of this Schedule”

(b)in paragraph 8 after the word “thereon” there shall be inserted the words “including any register or other record referred to in paragraph 16(3)(b) of this Schedule”

(c)after paragraph 15 there shall be inserted the following paragraph—

“16.—(1) Subject to sub-paragraph (5) below, the licence holder shall at all times have at his disposal the services of a person who as respects qualifications and experience satisfies the provisions of Articles 23 and 24 of the Second Council Directive, to carry out the functions specified in sub-paragraph (3) below (“qualified person”). For the purposes of this paragraph, but without prejudice to sub-paragraph (4) below, the licence holder may regard a person as satisfying the provisions of the said Article 24 as respects formal qualifications if he produces evidence that he is a member of the Pharmaceutical Society or of the Royal Institute of Chemistry or of such other body as may appear to the licensing authority to be an appropriate body for the purpose, and that he is regarded by the body of which he is a member as so satisfying those provisions.

(2) The licence holder shall at all times provide and maintain such staff, premises, equipment and facilities as will enable the qualified person who is at his disposal to carry out the said functions.

(3) The functions to be carried out by the qualified person shall be as follows—

(a)to ensure that each batch of the medicinal product to which the licence relates has been manufactured or assembled and checked in compliance with the provisions of the Act and regulations made thereunder, the provisions of the licence and the provisions of the product licence which relates to the product;

(b)to certify in a register, or other record appropriate for the purpose, whether each production batch of the medicinal product to which the licence relates satisfies the requirements set out in (a) above and to ensure that such register or other record is regularly maintained, in particular that the appropriate entries in such register or other record are made as soon as practicable after each such batch has been manufactured.

(4) Where, after giving the licence holder and the person acting as a qualified person the opportunity of making representations to them (orally or in writing), the licensing authority are of the opinion that the person so acting does not satisfy the provisions of the said Articles 23 and 24 of the Second Council Directive as respects qualifications and experience, or that he is failing to carry out the functions specified in sub-paragraph (3) above, and have notified the licence holder accordingly in writing, the licence holder shall not permit that person to act as a qualified person so long as the said notification has not been withdrawn by the licensing authority.

(5) The provisions of this paragraph shall not apply in relation to veterinary drugs or to medicinal products consisting of vaccines, toxins or serums, medicinal products based on human blood or blood constituents, radioactive isotopes or medicinal products that are homoeopathic products.

(6) The provisions of this paragraph shall also not apply where the licence relates to manufacturing activity which—

(a)is limited to medicinal products to which Article 2 of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(1) as amended(2) applies, and consists solely of mixing together medicinal products and ingredients, other than active ingredients, on premises of which the licence holder is the occupier and which he is able to close so as to exclude the public, or

(b)is limited to assembly only, where all the products to be assembled are for sale or supply in the course of a business and are supplied, without any recommendation, for the purpose of administration to a particular person after the licence holder has been requested by or on behalf of that person, and in that person's presence, to use his judgment as to the treatment required.

(7) The provisions of this paragraph shall not have effect until 22nd November 1977 in relation to a licence which has been granted before the coming into operation of these regulations.”.