UK Legislation on the Manufacture, Importation and Distribution of Active Substances
The Human Medicines Regulations 2012 (SI 2012/1916)
Editor’s note
These extracts from the Human Medicines Regulations 2012 [SI 2012/1916] as amended by the Human Medicines (Amendment) Regulations 2013 [SI 2013/1855] are presented for the reader’s convenience. Reproduction is with the permission of HMSO and the Queen’s Printer for Scotland. For any definitive information reference must be made to the original Regulations. The numbering and content within this section corresponds with the regulations set out in the published Statutory Instrument (SI 2012 No. 1916) as amended.
Citation and commencement
1 (1) These Regulations may be cited as the Human Medicines Regulations 2012.
(2) These Regulations come into force on 14th August 2012.
General interpretation
8 (1) In these Regulations (unless the context otherwise requires)- “active substance” means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;
“assemble”, in relation to a medicinal product or an active substance, includes the various processes of dividing up, packaging and presentation of the product or substance, and “assembly” has a corresponding meaning;
“excipient” means any constituent of a medicinal product other than the active substance and the packaging material;
“export” means export, or attempt to export, from the United Kingdom, whether by land, sea or air;
“falsified medicinal product” means any medicinal product with a false representation of:
(a) its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
(c) its history, including the records and documents relating to the distribution channels used;
“import” means import, or attempt to import, into the United Kingdom, whether by land, sea or air;
(8) References in these Regulations to:
(a) good manufacturing practice for active substances relate to the principles and guidelines for good manufacturing practice adopted by the European Commission under the third paragraph of Article 471 of the 2001 Directive;
(b) good distribution practice for active substances relate to the guidelines on good distribution practices for active substances adopted by the European Commission under the fourth paragraph of Article 47 of the 2001 Directive.
Chapter 1 Manufacture and distribution of medicinal products and active substances
INTERPRETATION
A17. In this Part “manufacture”, in relation to an active substance, includes any process carried out in the course of making the substance and the various processes of dividing up, packaging, and presentation of the active substance.
Chapter 4 Importation, manufacture and distribution of active substances
CRITERIA FOR IMPORTATION, MANUFACTURE OR DISTRIBUTION OF ACTIVE SUBSTANCES
45M. (1) A person may not:
(a) import;
(b) manufacture; or
(c) distribute,
an active substance unless that person is registered with the licensing authority in accordance with regulation 45N and the requirements in regulation 45O are met.
(2) Paragraph (1) applies in relation to an active substance which is to be used in an investigational medicinal product only:
(a) if the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration; and
(b) to the extent that the manufacture of the active substance is in accordance with the terms and conditions of that authorisation, certificate or registration.
(3) Paragraph (1)(a) does not apply to a person who, in connection with the importation of an active substance from a state other than an EEA state:
(a) provides facilities solely for transporting the active substance; or
(b) acting as an import agent, imports the active substance solely to the order of another person who holds a certificate of good manufacturing practice issued by the licensing authority.
Registration in relation to active substances
45N. (1) For registration in relation to active substances, the licensing authority must have received a valid registration form from the applicant for import, manufacture or, as the case may be, distribution of the active substance and:
(a) 60 days have elapsed since receipt and the licensing authority have not notified the applicant that an inspection will be carried out; or
(b) the licensing authority:
(i) notified the applicant within 60 days of receipt of a registration form that an inspection will be carried out; and
(ii) within 90 days of that inspection the licensing authority have issued that person with a certificate of good manufacturing practice or, as the case may be, of good distribution practice; and
(c) that person has not instructed the licensing authority to end that person’s registration.
(2) The person applying for registration under paragraph (1) must notify the licensing authority of any changes which have taken place as regards the information in the registration form:
(a) immediately where such changes may have an impact on quality or safety of the active substances that are manufactured, imported or distributed;
(b) in any other case, on each anniversary of the receipt of the application form by the licensing authority.
(3) For the purpose of paragraph (2), changes which are notified in accordance with that paragraph shall be treated as incorporated in the application form.
(4)
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
