The Human Medicines Regulations 2012

PART 1 U.K. Manufacturer's licence relating to manufacture and assembly

1.  The provisions of this Part are standard provisions of a manufacturer's licence relating to the manufacture or assembly of medicinal products. U.K.

2.  The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 1(2)(g) of Schedule 3. U.K.

3.  The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if the laboratory is operated by a person approved by the licensing authority. U.K.

4.  The licence holder must provide such information as may be requested by the licensing authority— U.K.

(a) about the products currently being manufactured or assembled by the licence holder; and

(b) about the operations being carried out in relation to such manufacture or assembly.

5.  The licence holder must inform the licensing authority of any change that the licence holder proposes to make to a person named in the licence as— U.K.

(a) the person whose duty it is to supervise the manufacturing or assembling operations;

(b) in charge of the animals from which are derived substances used in the production of the medicinal products being manufactured or assembled; or

(c) responsible for the culture of living tissues used in the manufacture of the medicinal products being manufactured or assembled.

6.  The licence holder must— U.K.

(a) keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

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

7.  The licence holder must keep readily available for examination by a person authorised by the licensing authority the samples in each batch of finished medicinal product referred to in Article 11(4) of the Good Manufacturing Practice Directive. U.K.

8.  Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with— U.K.

(a) the specification for the finished product; or

(b) the provisions of these Regulations applicable to the medicinal product,

the holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for a period (not exceeding six weeks) specified by the licensing authority.

9.  The licence holder must ensure that tests for determining conformity with the standards and specifications applying to a product used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that product otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage of the manufacture as may be approved by the licensing authority. U.K.

10.  Where the manufacturer's licence relates to the assembly of a medicinal product or class of product, and the licence holder supplies the product at such a stage of assembly that does not fully comply with the provisions of the product specification which relate to labelling, the licence holder must communicate the particulars of those provisions to the person to whom that product has been supplied. U.K.

11.  Where— U.K.

(a) the manufacturer's licence relates to the assembly of a medicinal product;

(b) the medicinal product is not manufactured by the licence holder; and

(c) particulars of the name and address of the manufacturer of the product, or the person who imports the product, have been given by the licence holder to the licensing authority,

the licence holder must immediately notify the licensing authority in writing of any changes in the particulars.

12.  The licence holder must keep readily available for examination by a person authorised by the licensing authority durable records of the details of the manufacture of intermediate products held by the licence holder for use in the manufacture of biological medicinal products, and the records must— U.K.

(a) be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of a finished biological medicinal product manufactured using those intermediate products; and

(b) not be destroyed without the consent of the licensing authority until the records of the details of manufacture of finished medicinal products which were or may be manufactured using those intermediate products may be destroyed in accordance with the requirements of these Regulations.

13.  Where— U.K.

(a) animals are used in the production of medicinal products; and

[F1 (b) in the case of a product for sale or supply—

(i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

contains provisions relating to them,]

the manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.

Textual Amendments

F1 Sch. 4 para. 13(b) substituted (31.12.2020) by S.I. 2019/775, reg. 20(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(a))

14.  The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided to the licensing authority is not false or misleading in any material particular if— U.K.

(a) it relates to a medicinal product which the licence holder manufactures or assembles; or

(b) it relates to any starting materials or intermediate products held by the licence holder which are for use in the manufacture of medicinal products.

[F2 14A.   A licence holder— U.K.

(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

F2 Sch. 4 para. 14A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 20(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(b))