The Human Medicines Regulations 2012

PART 3 Obligations of qualified person

12.  The qualified person is responsible for securing—

(a) that each batch of medicinal products manufactured in the United Kingdom has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(b) in the case of medicinal products imported from a non-EEA State, irrespective of whether the products have been manufactured in an EEA State, that each batch has undergone—

(i) a full qualitative analysis,

(ii) a quantitative analysis of all the active substances, and

(iii) all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products.

13.—(1) This paragraph applies where—

(a) a medicinal product which has undergone the controls referred to in paragraph 12 in another member State is imported to the United Kingdom; and

(b) each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12.

14.—(1) This paragraph applies where—

(a) medicinal products are imported from a country other than an EEA State; and

(b) appropriate arrangements have been made by the European Union with that country to ensure that—

(i) the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down by the European Union, and

(ii) the controls referred to in paragraph 12(b) have been carried out in that country.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12.

15.—(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.

(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.