The Human Medicines Regulations 2012 No. 1916

SCHEDULES

[F1 SCHEDULE 33A U.K. Transitional provision in relation to EU Exit

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)

PART 4 U.K. Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices

Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B) U.K.

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

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

(b) that authorisation is in force 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 60B(2) (requirement to submit samples and other information to the appropriate authority).

(2) Where this sub-paragraph applies, the EU marketing authorisation is deemed to be subject to the batch testing requirement in regulation 60B on and after IP completion day.

(3) Sub-paragraph (4) applies where a holder of an EU 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 60B(2).

(4) Where this sub-paragraph applies, the holder of the EU marketing authorisation is deemed to have satisfied the batch testing requirement in regulation 60B 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) Sub-paragraphs (5) and (6) of paragraph 29 apply in relation to the appropriate authority’s management of the list published under regulation 60A(5) for the purposes of this paragraph and regulation 60B.]