The Human Medicines Regulations 2012

[F1 Applications for EU marketing authorisations made before IP completion day U.K.

31.— (1) Sub-paragraph (2) applies where, before IP completion day—

(a) an application has been made to the EMA for an EU marketing authorisation; but

(b) no final decision has been made by the European Commission in relation to the grant of an EU marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2) Where this sub-paragraph applies, the applicant may apply to the licensing authority for the grant of a UK marketing authorisation by submitting to the licensing authority—

(a) a copy of the application for the EU marketing authorisation; and

(b) if requested by the licensing authority, such material or information that the licensing authority reasonably considers necessary for dealing with the application.

(3) Sub-paragraph (4) applies where, before IP completion day and in relation to an application to which sub-paragraph (2) applies, a final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use and the United Kingdom concurred with that opinion.

(4) Where this sub-paragraph applies, the licensing authority must grant a UK marketing authorisation in response to an application as described in sub-paragraph (2) as soon as reasonably practicable after it is received.

(5) Sub-paragraph (6) applies where before IP completion day, in relation to an application to which sub-paragraph (2) applies—

(a) no final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use; or

(b) such an opinion has been given but the United Kingdom recorded a divergent opinion.

(6) Where this sub-paragraph applies, the licensing authority must consider an application made under sub-paragraph (2) in accordance with Part 5 of these Regulations (marketing authorisations).]

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)