The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Validity of conditional marketing authorisation and variation of a UK marketing authorisation U.K.

72.  After regulation 65A M1 , insert—

“Validity of conditional marketing authorisation

65B.— (1) A conditional marketing authorisation remains in force—

(a) for an initial period of one year beginning with the date on which it is granted; and

(b) if it is renewed in accordance with regulation 66B, for further periods of one year beginning with the date on which the renewal is granted.

(2) If an application for the renewal or further renewal of a conditional marketing authorisation is made in accordance with regulation 66B the authorisation remains in force until the licensing authority notifies the applicant of its decision on the application.

Variation of a [F1 UKMA(GB)]

65C.— (1) A [F2 UKMA(GB)] holder may apply to vary the authorisation.

(2) Any such application must be made in accordance with Schedule 10A.

(3) Schedule 10A does not apply to the transfer of a [F2 UKMA(GB)] from one person to another.

(4) The licensing authority may publish guidance on the details of the various categories of variations, on the operation of the procedures laid down in Schedule 10A, and on the documentation to be submitted pursuant to those procedures.

(5) Any guidance referred to in paragraph (4) must be regularly reviewed and, when necessary, updated.

(6) Unless replaced by guidelines published under paragraph (4), the guidelines published by the Commission under Article 4 of Regulation (EC) No 1234/2008 M2 which applied immediately before [F3 IP completion day], insofar only as they concern applications under Chapter IIa of that Regulation, continue to apply to—

(a) applications made under regulation 65C on or after [F3 IP completion day]; or

(b) applications made before [F3 IP completion day] to which regulation 65C and Schedule 10A apply by virtue of Parts 3 and 5 of Schedule 33A.

(7) The Ministers may by regulations amend Schedule 10A.”.

Textual Amendments

F1 Word in reg. 72 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 54(a)

F2 Word in reg. 72 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 54(b)

F3 Words in reg. 72 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 54(c)

Commencement Information

I1 Reg. 72 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Regulation 65A was inserted by S.I. 2014/1878.

M2 The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.