The Human Medicines Regulations 2012

[F1 Requirements for registration as an importer, manufacturer or distributor of an active substance U.K.

45O.— (1) Where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance manufactured in the UK, the manufacturer must comply with good manufacturing practice in relation to that active substance.

(2) Where the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies to an active substance distributed in the United Kingdom, the distributor must comply with good distribution practice in relation to that active substance.

(3) Without prejudice to regulation 37(4) (manufacture and assembly in relation to active substances) and paragraph 9A of Schedule 8 (material to accompany an application for a UK marketing authorisation in relation to an active substance), where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance imported into the UK and where an active substance is imported from a third country—

(a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance;

(b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice; and

(c) the active substances must be accompanied by a written confirmation from the competent authority of the exporting third country of the following—

(i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union, and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.

(4) Paragraph (3)(c) does not apply—

(a) where the country from where the active substance is exported is included in the list referred to in Article 111b of the 2001 Directive; or

(b) for a period not exceeding the validity of the certificate of good manufacturing practice, where—

(i) in relation to a plant where active substances are manufactured where the competent authority of a member State has found, upon inspection, that a plant complies with the principles and guidelines of good manufacturing practice, and

(ii) the licensing authority is of the opinion that it is necessary to waive the requirement to ensure availability of the active substance.

(5) The criteria in this regulation apply regardless of whether an active substance is intended for export.]

Textual Amendments

F1 Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16