The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Requirement that manufacturer’s licence holders comply with certain obligations in relation to the manufacture and assembly of relevant medicinal products

2.—(1) In relation to the manufacture and assembly of relevant medicinal products, a manufacturer’s licence holder shall—

(a) comply with the principles and guidelines of good manufacturing practice;

(b) comply with the requirements of paragraph (3); and

(c) subject to paragraph (2), use active substances as starting materials only where those active substances have been manufactured or assembled in accordance with the principles and guidelines of good manufacturing practice applicable to starting materials;

(2) A manufacturer’s licence holder shall not be required to comply with the requirement of paragraph (1)(c) in relation to the manufacture or assembly of relevant medicinal products pursuant to his manufacturer’s licence, insofar as such activity is limited to the manufacture or assembly of exempt relevant medicinal products.

(3) The requirements of this paragraph are that the manufacturer’s licence holder shall—

(a) maintain such staff, premises, equipment and facilities as are necessary for such stages of the manufacture and assembly of relevant medicinal products as are undertaken by him in accordance with the requirements of—

(i) his licence, and

(ii) the marketing authorizations of the relevant medicinal products in question;

(b) maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of the relevant medicinal products which he handles, stores and distributes under his licence, as are necessary to maintain the quality of those medicinal products;

(c) ensure that any arrangements he makes with any person for the control, storage and distribution of the relevant medicinal products are adequate to maintain the quality of those products;

(d) not carry out any manufacture or assembly of relevant medicinal products other than—

(i) the manufacture or assembly of those classes of relevant medicinal product specified in his licence, and

(ii) at the premises specified in his licence;

(e) not use any premises for the handling, control, storage or distribution of relevant medicinal products other than those specified in his licence as approved by the licensing authority for that purpose, or approved by the licensing authority for that purpose from time to time;

(f) inform the licensing authority before making any material alteration to the premises or facilities used under his licence, or in the operations for which they are used;

(g) inform the licensing authority of any change that he proposes to make to any personnel named in his licence as responsible for quality control of the medicinal products being manufactured or assembled by him, including the person named as the qualified person for the purposes of regulation 4;

(h) for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(i) for suspending, revoking or varying any licence granted under Part II of the Act; or

(ii) suspending or terminating any licence in accordance with the provisions of Part II of the Act,

permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of his credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence;

(i) ensure that any blood or blood component imported into the United Kingdom and used by him as a starting material or raw material in the manufacture of a relevant medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC, implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components; and

(j) shall, where he distributes by way of wholesale dealing, any relevant medicinal product manufactured or assembled pursuant to his licence, comply with the requirements of regulations 8(1)(a) and (b) and (2), and 9 (2) and (3), as if he was the holder of a wholesale dealer’s licence.