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)- “brokering” means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person;
“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.

Brokering in medicinal products

45A. (1) A person may not broker a medicinal product unless:

(a) that product is covered by an authorisation granted:

(i) under Regulation (EC) No 726/2004; or

(ii) by a competent authority of a member State; and

(b) that person:

(i) is validly registered as a broker with a competent authority of a member State,

(ii) except where the person is validly registered with the competent authority of another EEA state, has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive insofar as those guidelines apply to brokers.

(2) A person is not validly registered for the purpose of paragraph (1)(b) if:

(a) the person’s permanent address is not entered into a register of brokers kept by a competent authority of a member State;

(b) the registration is suspended; or

(c) the person has notified the competent authority of a member State to remove that person from the register.

(3) Paragraph (1)(b)(i) does not apply until 20th October 2013 in relation to a person who brokered any medicinal product before 20th August 2013.

Application for brokering registration

45B. (1) The licensing authority may not register a person as a broker unless paragraphs (2) to (7) are complied with.

(2) An application for registration must be made containing:

(a) the name of the person to be registered;

(b) the name under which that person is trading (if different to the name of that person);

(c) that person’s:

(i) permanent address in the United Kingdom,

(ii)