The Human Medicines Regulations 2012

Miscellaneous and offences U.K.

Certification of manufacturer's licence U.K.

31.—(1) The licensing authority must issue a certificate in accordance with the following paragraphs of this regulation in relation to a manufacturer's licence relating to the manufacture or assembly of medicinal products if requested to do so by—

(a) subject to paragraph (5), the holder of the licence;

(b) a person who intends to export a medicinal product manufactured or assembled by the holder under the licence; or

(c) the competent authorities of a country other than an EEA State into which a medicinal product manufactured or assembled under the licence is, or is proposed to be, imported.

(2) The certificate must contain —

(a) information sufficient to identify the holder of the manufacturer's licence;

(b) details of the medicinal products that may be manufactured or assembled under the licence; and

(c) any other information concerning the holder, the product or the licence that the licensing authority thinks it appropriate to include, including information relating to clinical trials.

(3) If—

(a) a request is made—

(i) under paragraph (1)(a) in relation to the export or the proposed export of a product, or

(ii) under paragraph (1)(b) or (c); and

(b) there is a marketing authorisation or a traditional herbal registration in force for any product to which the licence relates,

the certificate must be accompanied by the summary of the product characteristics relating to that product.

(4) The licensing authority may restrict the information provided under sub-paragraphs (2)(a) and (b) and paragraph (3) to information relating to the specific medicinal products mentioned in the request made under paragraph (1).

(5) A licence holder who makes a request under paragraph (1) must—

(a) produce to the licensing authority a marketing authorisation, certificate of registration or traditional herbal registration in relation to any product to which the certificate is to relate; or

(b) make a declaration to the licensing authority explaining why no marketing authorisation, certificate of registration or traditional herbal registration is available.

(6) The licensing authority must have regard to the prevailing administrative arrangements of the World Health Organisation when issuing the certificate.

Sale and supply of starting materials U.K.

32.  A person must not sell or supply an active substance if the active substance—

(a) has not been manufactured or assembled in accordance with the principles and guidelines for good manufacturing practice applicable to starting materials and set out in the Good Manufacturing Practice Directive; and

(b) is sold or supplied to a person for use in the manufacture of a medicinal product, except where—

(i) the product is a special medicinal product, or

(ii) regulation 17(1) (manufacturing of medicinal products) does not apply to the manufacture of the product by virtue of any provision of section 10 of the Medicines Act 1968.

Offence concerning data for advanced therapy medicinal products U.K.

33.—(1) A person who is, or immediately before its revocation or suspension was, the holder of a manufacturer's licence relating to an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a) keep the data referred to in Article 15(1) of Regulation (EC) No 1394/2007 in accordance with the requirements of Article 15(4) of that Regulation; or

(b) transfer the data referred to in Article 15(1) to the licensing authority in the event of that person's bankruptcy or liquidation,

but this is subject to paragraphs (2) and (3).

(2) Sub-paragraph (1)(b) does not apply if—

(a) the person is bankrupt or in liquidation and has transferred the data to another person; or

(b) the period for which the person was required to keep the data in accordance with the requirements of Article 15(4) mentioned in sub-paragraph (1)(a) has expired.

(3) It is a defence for a person charged with an offence under paragraph (1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of the offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

Offences: breach of regulations and false information and defence concerning starting materials U.K.

34.—(1) A person is guilty of an offence if the person contravenes the provisions of regulation 17(1), 18(1) or 32.

(2) A person is guilty of an offence if the person knowingly gives false information in response to a notice under regulation 30(1).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 30(2).

(4) The defence in paragraph (5) applies to a person who is charged under paragraph (1) with an offence of contravening regulation 17(1) (prohibition on manufacturing a medicinal product except in accordance with a licence) by virtue of a breach of regulation 37(2)(b) (requirement that active substances used as starting materials are manufactured or assembled in accordance with the Good Manufacturing Practice Directive).

(5) It is a defence for the person to show that the person could not, by taking all reasonable precautions and exercising all due diligence, have discovered that an active substance was not manufactured in accordance with regulation 37(2)(b).

Penalties U.K.

35.—(1) A person guilty of an offence under regulation 33(1) or regulation 34(1) or (2) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 34(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.