Regulation 65 Validity of UK marketing authorisation

(1)

Subject to the following paragraphs, a UK marketing authorisation remains in force—

(a)

for an initial period of five years beginning with the date on which it is granted; and

(b)

if the authorisation is renewed in accordance with regulation 66, for an unlimited period after its renewal.

(2)

The licensing authority may, on the first application for renewal of an authorisation, determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3)

In that event the authorisation remains in force—

(a)

for a further period of five years beginning with the date on which it is first renewed; and

(b)

if the authorisation is further renewed under regulation 66, for an unlimited period after its further renewal.

(4)

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

(5)

This regulation is subject to—

F1(za)

regulation 65B;

(a)

regulation 67 (failure to place on the market etc); and

(b)

regulation 68 (revocation etc of marketing authorisations).

Annotations

Textual amendments

F1: Reg. 65(5)(za) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 71; 2020 c. 1, Sch. 5 para. 1(1)