Paragraph 37 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion dayF1

(1)

Sub-paragraph (2) applies where—

(a)

a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day; but

(b)

that procedure has not concluded before IP completion day.

(2)

Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 (revocation, variation and suspension of UK marketing authorisation) as soon as reasonably practicable.

(3)

In making a decision under regulation 68 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a)

any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b)

any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive; and

(c)

any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11.

(4)

Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use or the Co-ordination Group for Mutual Recognition and Decentralised Procedures (as the case may be) has given a final opinion in relation to the matter referred under Article 31 of the 2001 Directive.

(5)

Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11 (advice and representations).

(6)

Sub-paragraph (7) applies where—

(a)

a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day;

(b)

that referral has concluded before IP completion day; but

(c)

the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(7)

Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the UK marketing authorisation—

(a)

as soon as reasonably practicable; and

(b)

in the case of a UK marketing authorisation that is not a converted EU marketing authorisation, within the period specified in Article 34(3) of the 2001 Directive (if relevant).

(8)

In this paragraph—

“concluded before IP completion day”, in relation to an Article 31 referral, means—
1. (a)
  a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or
2. (b)
  an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and
“specified matter” means—
1. (a)
  a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a UK marketing authorisation or an EU marketing authorisation; but
2. (b)
  does not include a referral made under Article 107i of the 2001 Directive.

Annotations

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)