The Veterinary Medicines Regulations 2013

PART 4 U.K. Variations of marketing authorisations on the application of the holder

Variation of a marketing authorisation E+W+S

33.—F3 (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The holder of a marketing authorisation may apply to the Secretary of State for a variation of that marketing authorisation.

[F4 (3) An application for a variation under paragraph (2) may only relate to—

(a) a single variation, which may relate to one or more marketing authorisations, or

(b) one or more variations to a single marketing authorisation.]

(4) The Secretary of State, when granting a variation of a veterinary medicinal product, may (unless there are exceptional circumstances necessary to protect human or animal health or the environment) specify transitional measures to enable products produced in accordance with the previous authorisation to continue to be marketed for the transitional period.

Textual Amendments

F3 Sch. 1 para. 33(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 53(a)

F4 Sch. 1 para. 33(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 53(b)

Variation of a marketing authorisation N.I.

33.—(1) The Secretary of State is the competent authority for the purposes of Commission Regulation (EC) No 1234/2008(1).

(2) The holder of a marketing authorisation may apply to the Secretary of State for a variation of that marketing authorisation.

(3) An application for a variation under paragraph (2) may only relate to a “single variation” unless the application is submitted in accordance with—

(a) Article 7 of Commission Regulation (EC) No 1234/2008 (“grouped variations”), or

(b) Article 20 of Commission Regulation (EC) No 1234/2008 (“workshare variations”).

(4) The Secretary of State, when granting a variation of a veterinary medicinal product, may (unless there are exceptional circumstances necessary to protect human or animal health or the environment) specify transitional measures to enable products produced in accordance with the previous authorisation to continue to be marketed for the transitional period.

Extent Information

E1 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F5 Variation procedure E+W+S

33A.— (1) Subject to sub-paragraphs (2) and (6), an application for a variation must be submitted to the Secretary of State electronically.

(2) Sub-paragraph (1) does not apply where the application is an emergency application.

(3) The application must contain—

(a) a description of the proposed variation;

(b) information in relation to any of the matters referred to in paragraph 2 which are relevant to the proposed variation;

(c) details of any marketing authorisation which may be affected by the proposed variation; and

(d) where the proposed variation requires consequential variations to the terms of the marketing authorisation, a description of those variations.

(4) The Secretary of State must produce an assessment of the application.

(5) The Secretary of State may require the applicant to provide additional information during the assessment process.

(6) Where the Secretary of State is satisfied that it is not necessary for the application to contain certain information for the purposes of conducting an assessment, having regard to the risks involved with the proposed variation, the Secretary of State may waive the requirement to provide that information under sub-paragraph (3) (and the requirement in sub-paragraph (4) does not apply in respect of that information).

(7) The Secretary of State must send a copy of the assessment mentioned in sub-paragraph (4) to the applicant.

(8) Having assessed the application, the Secretary of State must—

(a) amend the authorisation to correspond with the proposed variation; or

(b) reject the proposed variation.

(9) Where the Secretary of State amends the authorisation in accordance with sub-paragraph (8)(a) the Secretary of State must notify the applicant in writing.

(10) The Secretary of State must ensure that the determination of an application for a variation of a marketing authorisation is completed within a maximum of 180 days after the submission of the application.]

Textual Amendments

F5 Sch. 1 para. 33A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 54

Refusal of a variation of a marketing authorisation E+W+S

34.—F6 (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The grounds on which the Secretary of State may refuse an application for a variation of a marketing authorisation are those set out in paragraph 24 of this Schedule (refusal of a marketing authorisation).

(3) The Secretary of State must give written reasons for refusing to grant a variation; and if—

(a) those reasons are on the grounds of safety, quality or efficacy; and

[F7 (b) the Secretary of State produced an assessment in respect of the variation under paragraph 33A(4),]

the applicant may appeal to the Veterinary Products Committee.

Textual Amendments

F6 Sch. 1 para. 34(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 55(a)

F7 Sch. 1 para. 34(3)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 55(b)

Refusal of a variation of a marketing authorisation N.I.

34.—(1) This paragraph applies in relation to the refusal by the Secretary of State of an application for a variation unless the procedure following the refusal of a variation is one of those set out in Article 13 of Regulation 1234/2008.

(2) The grounds on which the Secretary of State may refuse an application for a variation of a marketing authorisation are those set out in paragraph 24 of this Schedule (refusal of a marketing authorisation).

(3) The Secretary of State must give written reasons for refusing to grant a variation; and if—

(a) those reasons are on the grounds of safety, quality or efficacy; and

(b) the variation is Type II or an extension application (whether or not in each case as part of an application for a worksharing or grouped application),

the applicant may appeal to the Veterinary Products Committee.

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Administrative variations U.K.

[F8 35.— (1) The holder of a marketing authorisation may apply for a minor change in a marketing authorisation to be made without the Secretary of State considering any scientific data (an “administrative variation”).

(2) If the Secretary of State grants an administrative variation, and subsequently establishes that this should have been a variation requiring consideration of scientific data, the Secretary of State may notify the marketing authorisation holder, require the holder to submit an application for a variation enabling data to be assessed and revoke the administrative variation.]

Textual Amendments

F8 Sch. 1 para. 35 omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 56

Changes after a marketing authorisation has been issued U.K.

36.  After a marketing authorisation has been issued, the holder must take account of scientific and technical progress in manufacturing and control methods, and apply to the Secretary of State for any variation in the marketing authorisation that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

Compulsory variation U.K.

37.—(1) If the Secretary of State decides, for any of the reasons for suspending a marketing authorisation specified in paragraph 38, or because the classification of a veterinary medicinal product should be changed, that a variation to a marketing authorisation is necessary, the Secretary of State must by a notification in writing to the holder of the marketing authorisation require that person to apply for a variation of the marketing authorisation, giving reasons for requiring the application to be made.

(2) The notification may specify a time limit within which the marketing authorisation holder must apply for the variation.

(3) If the variation is on the grounds of safety, quality or efficacy, the applicant may, within 28 days of the notification, appeal to the Veterinary Products Committee.

(4) If the marketing authorisation holder fails to apply for the variation within that time limit the Secretary of State may suspend or revoke the marketing authorisation.

(1)

OJ No L334, 12.12.2008, p. 7.