The Human Medicines Regulations 2012

Duties of authorisation holders and registration holdersU.K.
This section has no associated Explanatory Memorandum

281.—(1) This regulation applies to a person who holds—

(a)a [F1UK] marketing authorisation for a medicinal product;

(b)a certificate of registration for a medicinal product;

(c)a traditional herbal registration for a medicinal product; F2...

(d)an Article 126a authorisation for a medicinal product [F3; or

(e)an EU marketing authorisation for a medicinal product.]

[F4(1A) Paragraphs (3) to (5) apply to the holder of a temporary authorisation in relation to a medicinal product.]

(2) The person must establish a scientific service to compile and collate all information relating to the product (whether received from medical sales representatives employed by that person or from any other source).

(3) The person must ensure that any medical sales representative who promotes the product is given sufficient training, and has sufficient scientific knowledge, to enable the representative to provide information about the product that is as precise and complete as possible.

(4) The person must retain—

(a)a sample of any advertisement for which the person is responsible relating to the product; and

(b)a statement indicating the persons to whom the advertisement is addressed, the method of its publication and the date when it was first published.

(5) The person must, if required to do so by notice given to the person by the Ministers, within the period specified in that notice—

(a)provide a copy of the sample and statement mentioned in paragraph (4) to the Ministers;

(b)supply such other information as the Ministers may request for the purposes of their functions under this Part; or

(c)provide such assistance as the Ministers may request for those purposes.

Textual Amendments