The Human Medicines Regulations 2012

Manufacturing and assembly

37.—(1) This regulation applies in relation to a manufacturer’s licence relating to the manufacture or assembly of medicinal products.

(2) The licence holder must—

(a) comply with the principles and guidelines for good manufacturing practice set out in the Good Manufacturing Practice Directive; and

(b) use active substances as starting materials only if those substances have been manufactured or assembled in accordance with the principles and guidelines mentioned in paragraph (a), in so far as those principles and guidelines relate to starting materials (but see paragraph (3)).

(3) The requirement in paragraph (2)(b) does not apply in relation to the manufacture or assembly of special medicinal products.

(4) The licence holder must maintain such staff, premises and equipment as are necessary for the stages of manufacture and assembly of medicinal products undertaken by the licence holder in accordance with—

(a) the manufacturer’s licence; and

(b) the marketing authorisations, Article 126a authorisations, certificates of registration or traditional herbal registrations applying to the medicinal products.

(5) The licence holder must not manufacture or assemble medicinal products, or classes of medicinal products, other than those specified in the licence.

(6) The licence holder must not manufacture or assemble medicinal products on premises other than those specified in the licence as approved by the licensing authority for the purpose.

(7) The licence holder must ensure that blood, or blood components, imported into the United Kingdom and used as a starting material or raw material in the manufacture of a medicinal product meet—

(a) the standards of quality and safety specified in Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components(1); or

(b) equivalent standards.

(1)

OJ L 91, 30.3.2004, p.25.