The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 3PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

1.  The holder of the authorisation shall—

(a)provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the investigational medicinal products which he handles, stores or distributes under his authorisation as are necessary to avoid deterioration of the investigational medicinal products;

(b)not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and

(c)ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products are adequate to maintain the quality of those products.

2.  The holder of the authorisation may use a contract laboratory pursuant to Article 11(2) of Commission Directive 2003/94/EC if operated by a person approved by the licensing authority.

3.  The holder of the authorisation shall provide such information as may be requested by the licensing authority concerning the type and quantity of any investigational medicinal products which he imports.

4.  The holder of the authorisation shall—

(a)inform the licensing authority before making any structural alterations to, or discontinuance of the use of, premises to which his authorisation relates; and

(b)inform the licensing authority if he changes the person named as the qualified person for the purposes of regulation 43 and paragraph 9.

5.  The holder of the authorisation shall—

(a)keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of Commission Directive 2003/94/EC; and

(b)permit the person authorised to take copies or make extracts from such documentation.

6.  Where the holder of the authorisation has been informed by the licensing authority that any batch of any investigational medicinal product to which his authorisation relates has been found not to conform as regards strength, quality or purity with—

(a)the specification of the relevant product; or

(b)the provisions of these Regulations, the Act or any regulations under the Act that are applicable to the investigational medicinal product,

he shall, if so directed, withhold such batch from distribution for use in clinical trials, so far as may be reasonably practicable, for such a period not exceeding six weeks as may be specified by the licensing authority.

7.  If the holder of the authorisation is not the sponsor of the clinical trial for which the investigational medicinal product is manufactured or assembled, he shall comply with the provisions of the product specification that relates to the supply of that investigational medicinal product for use in the trial.

8.  The holder of the authorisation, for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(a)for suspending, revoking or varying any authorisation or licence granted under these Regulations or Part II of the Act;

(b)amending the conduct of a clinical trial in accordance with regulation 23 or 24; or

(c)suspending or terminating any clinical trial in accordance with regulation 31,

shall permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of his credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the authorisation, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for an authorisation or licence.

9.  The holder of the authorisation shall at all times provide and maintain such staff, premises, equipment and facilities as will enable the qualified person who is at his disposal pursuant to regulation 43(1) to carry out the duties referred to in regulation 43(2).