The Human Medicines Regulations 2012

[F1 Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A) U.K.

29.— (1) Sub-paragraph (2) applies where—

(a) a marketing authorisation was in force before IP completion day,

(b) that authorisation is in force as a UK marketing authorisation on IP completion day (whether or not it is suspended); and

(c) that authorisation is for a medicinal product of a type that is specified in regulation 60A(2)(a) to (e) (condition as to the submitting of samples and other information to the appropriate authority).

(2) Where this sub-paragraph applies, the UK marketing authorisation is deemed to include the batch testing condition on and after IP completion day.

(3) Sub-paragraph (4) applies where a holder of a UK marketing authorisation has, before IP completion day, submitted to a competent authority of an EEA State samples for testing from a batch of a medicinal product (“the relevant batch”) that—

(a) is the subject of that authorisation; and

(b) is of a type specified in regulation 60A(2)(a) to (e).

(4) Where this sub-paragraph applies, the holder of the UK marketing authorisation is deemed to have satisfied the batch testing condition in respect of the relevant batch if, before IP completion day—

(a) the competent authority of that EEA State examines the sample from the relevant batch; and

(b) that authority declared it to be in conformity with the approved specifications (within the meaning of Article 114 of the 2001 Directive) before IP completion day.

(5) The appropriate authority—

(a) must include each EEA State on the list it publishes under regulation 60A(5) on IP completion day; and

(b) must not, before the end of the transitional period, exercise its powers under regulation 60A(8) to remove an EEA State from the list it publishes under regulation 60A(5).

(6) For the purposes of regulation 60A(9), the appropriate authority must, on IP completion day—

(a) include Switzerland and Israel in the list it publishes under that paragraph; and

(b) include in respect of those countries any conditions or restrictions in the arrangement with those countries that affect the applicability of the batch testing exemption.

(7) In this paragraph—

(a) “the transitional period” means the period of 24 months beginning with IP completion day; and

(b) “the batch testing condition” and “the batch testing exemption” have the same meaning as in regulation 60A.

(8) This paragraph, with the exception of sub-paragraphs (3) and (4), applies equally to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this paragraph (other than in this sub-paragraph) to—

(a) a marketing authorisation or a UK marketing authorisation is to be read as a reference to a parallel import licence for a medicinal product, and

(b) the holder of a UK marketing authorisation is to be read as a reference to the holder of a parallel import licence.]

Textual Amendments

F1 Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)