The Human Medicines Regulations 2012

Validity of UK marketing authorisation U.K.

Validity of UK marketing authorisation U.K.

65.—(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).

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)

[F2 Validity of parallel import licence U.K.

65A.— (1) Unless paragraph (2) applies, a parallel import licence remains in force for a period of 5 years from the date it is granted or renewed.

(2) A parallel import licence will cease to be valid if—

(a) the information supplied in the application for a licence no longer matches the information currently approved for the reference product by the licensing authority;

(b) details about the product imported under the licence are not consistent with the details supplied in the application; or

(c) the patient information leaflet supplied with the product is not consistent with latest version of the leaflet that is required to be issued with the product by the licensing authority, and

an application to vary the licence to update any details in relation to sub-paragraph (a) to (c) has not been granted by the licensing authority because the condition in regulation 68(11) has not been met.]

Textual Amendments

F2 Reg. 65A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 9 and reg. 65A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 9

[F3 Validity of conditional marketing authorisation U.K.

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.

Textual Amendments

F3 Regs. 65B, 65C inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 72 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 54); 2020 c. 1, Sch. 5 para. 1(1)

Variation of a UKMA(GB) U.K.

65C.— (1) A 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 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 which applied immediately before 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 IP completion day; or

(b) applications made before 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

F3 Regs. 65B, 65C inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 72 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 54); 2020 c. 1, Sch. 5 para. 1(1)

Application for renewal of authorisation U.K.

66.—(1) The licensing authority may renew a UK marketing authorisation in response to an application made in accordance with this regulation.

[F4 (2) The applicant, where it is applying for renewal of—

(a) a UKMA(NI)—

(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii) on any other basis, must be established in the United Kingdom;

(b) a UKMA(GB)—

(i) under the unfettered access route, must be established in Northern Ireland;

(ii) other than under the unfettered access route, must be established in the United Kingdom;

(c) a UKMA(UK), must be established in the United Kingdom.]

(3) The application must be—

(a) made in writing;

(b) signed by or on behalf of the applicant; and

(c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (as the case may be) (3)(a) of regulation 65 (initial and further period of validity).

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy, including—

(a) the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and

(b) all amendments made since the authorisation was granted.

(7) The licensing authority may renew a UK marketing authorisation only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the authorisation relates outweigh the risks of the product to the health of patients or of the public.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a UK marketing authorisation.

Textual Amendments

F4 Reg. 66(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 74 (as amended by (S.I. 2020/1488), reg. 1, Sch. 2 para. 55); 2020 c. 1, Sch. 5 para. 1(1)

[F5 Application for renewal of a parallel import licence U.K.

66A.— (1) The licensing authority may renew a parallel import licence in response to an application made in accordance with this regulation.

(2) The applicant must be established in the [F6 United Kingdom].

(3) The application must be—

(a) made in writing;

(b) signed by or on behalf of the applicant; and

(c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority within three months of the end of a period expiring 5 years after the date of grant or (as the case may be) latest renewal of the licence.]

Textual Amendments

F5 Reg. 66A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 10 and reg. 66A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 10

F6 Words in reg. 66A(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 75; 2020 c. 1, Sch. 5 para. 1(1)

[F7 Renewal of conditional marketing authorisation U.K.

66B.— (1) The licensing authority may renew a conditional marketing authorisation in relation to an application made to it by the holder of the authorisation.

(2) The application must be made at least six months before the date on which the conditional marketing authorisation is due to expire.

(3) The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.

(4) When considering an application under paragraph (1), the licensing authority must consider whether—

(a) the positive therapeutic effects of the product continue to outweigh the risks to the health of patients and the public associated with the product; and

(b) the obligations referred to in regulation 59(4C) and any time limits for their fulfilment remain appropriate, modifying or removing them if necessary.

(5) The provisions of regulation 66(2), (3), (4), (6) and (8) apply to an application for renewal of a conditional marketing authorisation.]

Textual Amendments

F7 Reg. 66B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 76; 2020 c. 1, Sch. 5 para. 1(1)

Failure to place on the market etc U.K.

67.—(1) A UK marketing authorisation ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom [F8 (or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain)] during the period of three years beginning immediately after the day on which it was granted.

(2) A UK marketing authorisation for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom [F9 (or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain)] for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a) in response to an application in writing by the holder of the UK marketing authorisation; or

(b) by the licensing authority of its own motion.

(5) An exemption may be granted only—

(a) in exceptional circumstances; and

(b) on public health grounds.

(6) An exemption—

(a) has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b) may be renewed or further renewed.

Textual Amendments

F8 Words in reg. 67(1) inserted (31.12.2020) by S.I. 2019/775, reg. 76A(2) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 56)

F9 Words in reg. 67(2) inserted (31.12.2020) by S.I. 2019/775, reg. 76A(3) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 56)