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17.—[F3(1)] The Secretary of State must ensure that the procedure for granting an authorisation for a veterinary medicinal product is completed within a maximum of 210 days after the submission of the application.
[F4(2) Sub-paragraph (1) does not apply where a simultaneous assessment of the application is being conducted by the Secretary of State and the relevant authority in another country.]
Textual Amendments
F3Sch. 1 para. 17 renumbered as Sch. 1 para. 17(1) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 41(a)
F4Sch. 1 para. 17(2) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 41(b)
18. Only an applicant established in the United Kingdom or in a country which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom may be granted (or hold) a marketing authorisation or a veterinary homeopathic registration.]
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F5Sch. 1 para. 18 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 42
18. Only an applicant established in [F35the United Kingdom or] a member State may be granted a marketing authorisation.
Extent Information
E8This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F35Words in Sch. 1 para. 18 inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(i)
19. The Secretary of State may require the applicant to provide additional information or to generate additional data, including laboratory testing, or may require the applicant to provide samples of any medicinal product, its starting materials and intermediate products or other constituent materials for testing in a laboratory.
F620. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F6Sch. 1 para. 20 omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(19) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
20. Where the Secretary of State is informed or discovers that [F36a] member State has authorised a veterinary medicinal product that is the subject of an application for authorisation by the Secretary of State, the Secretary of State must reject the application unless it was submitted in accordance with the mutual recognition procedure or the decentralised procedure in Part 6.
Extent Information
E9This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F36Word in Sch. 1 para. 20 substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(ii)
21. The Secretary of State must produce an assessment of the dossier, consisting of an evaluation of the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned, and any additional related information.
22.—[F7(1) The Secretary of State must, before granting a marketing authorisation—
(a)verify that the data submitted complies with the requirements set out in these Regulations;
(b)assess the application and data submitted in respect of the veterinary medicinal product; and
(c)reach a conclusion in relation to the benefit-risk balance of granting a marketing authorisation in respect of the veterinary medicinal product.]
[F8(2)] When granting a marketing authorisation, the Secretary of State must inform the applicant of the summary of product characteristics that has been approved, and the distribution category of the product.
[F9(3) The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation.
(4) Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.]
Textual Amendments
F7Sch. 1 para. 22(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 43(b)
F8Sch. 1 para. 22 renumbered as Sch. 1 para. 22(2) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 43(a)
F9Sch. 1 para. 22(3)(4) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 43(c)
22A.—(1) Where an applicant for a marketing authorisation withdraws the application before the Secretary of State has produced an assessment of the dossier under paragraph 21 the applicant must give written reasons for so doing.
(2) Where an applicant withdraws an application for a marketing authorisation in the circumstances mentioned in sub-paragraph (1) the Secretary of State must publish—
(a)the fact that the application has been withdrawn; and
(b)a summary of the reasons for withdrawal.]
Textual Amendments
F10Sch. 1 para. 22A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 44
23.—(1) The Secretary of State must not grant a marketing authorisation for a veterinary medicinal product for food-producing species unless [F11maximum residue limits have been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council in respect of ] all its pharmacologically active substances F12....
(2) This does not apply in the case of a marketing authorisation for a veterinary medicinal product for administration to a horse that has been declared on its horse passport as not intended for slaughter for human consumption; but in this case the product must not include an active substance that [F13has been classified under Article 14 of Regulation (EC) No 470/2009 of the European Parliament and of the Council as prohibited for use in food producing animals.]
Extent Information
E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F11Words in Sch. 1 para. 23(1) inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(20)(a)(i) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Sch. 1 para. 23(1) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(20)(a)(ii) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Sch. 1 para. 23(2) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(20)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
23.—(1) The Secretary of State must not grant a marketing authorisation for a veterinary medicinal product for food-producing species unless all its pharmacologically active substances appear in Table 1 in the Annex to Commission Regulation (EU) No 37/2010.
(2) This does not apply in the case of a marketing authorisation for a veterinary medicinal product for administration to a horse that has been declared on its horse passport as not intended for slaughter for human consumption; but in this case the product must not include an active substance that appears in Table 2 in the Annex to Commission Regulation (EU) No 37/2010 and must not be intended for the treatment of a condition for which a veterinary medicinal product is already authorised for horses.
Extent Information
E10This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
24.—(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.
(2) In addition, the Secretary of State must refuse to grant it if—
(a)the data submitted with the application are inadequate;
(b)the [F14benefit-risk balance] of the veterinary medicinal product is unfavourable;
[F15(c)the applicant has not provided sufficient evidence of the efficacy of the product in relation to the target species;]
(d)the withdrawal period proposed by the applicant is not long enough to ensure [F16food safety], or is insufficiently substantiated;
(e)the veterinary medicinal product is for a prohibited use;
(f)the way that the product will be used will have an unnecessarily undesirable effect on the environment.
[F17(g)the veterinary medicinal product is a veterinary medicinal product which contains an antimicrobial which is presented for use in order to promote the growth of treated animals or to increase yields from treated animals;
(h)the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;
(i)the risks to public or animal health or to the environment are not sufficiently addressed;
(j)the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;
(k)the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bio-accumulative and toxic and the veterinary medicinal product is intended to be used in food-producing animals (except where it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health).]
(3) The Secretary of State may refuse to grant a marketing authorisation—
(a)if there is F18... legislation pending that is incompatible with the requested authorisation; or
(b)if additional data have been requested and those data are not provided within such time limit as may be stipulated.
(4) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to refuse an application, or proposes to grant a marketing authorisation that is different from the one applied for, the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee.
Extent Information
E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F14Words in Sch. 1 para. 24(2)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 45(a)
F15Sch. 1 para. 24(2)(c) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 45(b)
F16Words in Sch. 1 para. 24(2)(d) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(21)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F17Sch. 1 para. 24(2)(g)-(k) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 45(c)
F18Word in Sch. 1 para. 24(3)(a) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(21)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
24.—(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.
(2) In addition, the Secretary of State must refuse to grant it if—
(a)the data submitted with the application are inadequate;
(b)the risk-benefit balance of the veterinary medicinal product is unfavourable;
(c)the product has insufficient therapeutic effect;
(d)the withdrawal period proposed by the applicant is not long enough to ensure that Regulation (EC) No 470/2009 of the European Parliament and of the Council is complied with, or is insufficiently substantiated;
(e)the veterinary medicinal product is for a prohibited use;
(f)the way that the product will be used will have an unnecessarily undesirable effect on the environment.
(3) The Secretary of State may refuse to grant a marketing authorisation—
(a)if there is Community legislation pending that is incompatible with the requested authorisation; or
(b)if additional data have been requested and those data are not provided within such time limit as may be stipulated.
(4) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to refuse an application, or proposes to grant a marketing authorisation that is different from the one applied for, the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee.
Extent Information
E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
25.—(1) On granting a marketing authorisation the Secretary of State must publish—
(a)the notice granting the marketing authorisation;
(b)the summary of the product characteristics;
(c)the assessment report that has already been prepared but with any commercially confidential or personal information deleted.
(2) The Secretary of State must update the assessment report whenever new information that is of importance and relates to the quality, safety or efficacy of the veterinary medicinal product becomes available.
(3) The Secretary of State must send a copy of the assessment report, and any update, to the holder of the marketing authorisation before publication to enable the holder to make representations concerning any confidential or personal information that may be in it, and may specify a date by which representations must be made.
[F20(4) Where the Secretary of State refuses to grant a marketing authorisation or suspends or revokes an authorisation the Secretary of State must publish that fact.
(5) Where the Secretary of State varies a marketing authorisation in relation to the summary of product characteristics the Secretary of State must publish the terms of the variation.]
Textual Amendments
F19Words in Sch. 1 para. 25 heading inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 46(b)
F20Sch. 1 para. 25(4)(5) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 46(a)
26.—(1) In exceptional circumstances, and if there is no other product with a full marketing authorisation for the indicated condition in the target species, the Secretary of State may grant an exceptional marketing authorisation consisting of—
(a)a provisional marketing authorisation subject to a requirement for the applicant to provide further data [F21, taking into account the benefit of the immediate availability on the market of the veterinary medicinal product in comparison to the risks]; or
(b)a limited marketing authorisation for a product with a limited market [F22, taking into account the benefit in relation to public or animal health of the availability of the product on the market in comparison to the risks.].
[F23(1A) An exceptional marketing authorisation may be granted subject to such further conditions, including any restrictions, as the Secretary of State considers appropriate.]
(2) The Secretary of State must reassess each provisional or limited marketing authorisation annually.
Textual Amendments
F21Words in Sch. 1 para. 26(1)(a) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 47(a)
F22Words in Sch. 1 para. 26(1)(b) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 47(b)
F23Sch. 1 para. 26(1A) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 47(c)
27.—(1) The Secretary of State may require a marketing authorisation holder to provide, at any time and at any stage of the manufacturing process, samples of starting materials or the veterinary medicinal product for testing [F24and to provide the results of any control tests carried out in relation to such materials or the finished product in accordance with the methods to be used under the terms of the marketing authorisation].
(2) At the request of the Secretary of State, the marketing authorisation holder must provide technical expertise to facilitate any analysis of the product.
[F25(3) The Secretary of State may require an applicant for a marketing authorisation to provide samples of a veterinary medicinal product for testing.
(4) The samples mentioned in sub-paragraph (3) may be used—
(a)to test the veterinary medicinal product and its constituents at any stage of development of the product in order to ensure that the control methods used by the manufacturer are satisfactory; and
(b)to verify that, where a veterinary medicinal product is intended for administration to a food-producing animal, the means used for residue detection in relation to pharmacologically active substances are satisfactory.]
Textual Amendments
F24Words in Sch. 1 para. 27(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 48(a)
F25Sch. 1 para. 27(3)(4) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 48(b)
28.—(1) A marketing authorisation holder must immediately inform the Secretary of State on receipt of any new information that might adversely affect the [F27benefit-risk balance] of the veterinary medicinal product.
(2) The holder must immediately inform the Secretary of State of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is authorised.
(3) The Secretary of State may at any time require the marketing authorisation holder to provide data relating to the [F27benefit-risk balance].
[F28(4) A marketing authorisation holder must retain all of the original documents from every clinical trial from which data was derived in support of the application for authorisation under this Schedule, and in support of any variation of the authorisation (whether granted or otherwise), for at least five years from the date on which the authorisation ceases.]
Textual Amendments
F26Words in Sch. 1 para. 28 heading inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(c)
F27Words in Sch. 1 para. 28 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(a)
F28Sch. 1 para. 28(4) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(b)
28.—(1) A marketing authorisation holder must immediately inform the Secretary of State on receipt of any new information that might adversely affect the risk-benefit balance of the veterinary medicinal product.
(2) The holder must immediately inform the Secretary of State of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is authorised.
(3) The Secretary of State may at any time require the marketing authorisation holder to provide data relating to the risk-benefit balance.
29.—[F29(1) Before placing an immunological product on the market the holder of the marketing authorisation must notify the Secretary of State asking for written approval to do so.]
(2) If notified under sub-paragraph [F30(1)] the Secretary of State must give or refuse a written approval as soon as is reasonably practicable.
(3) No person may place an immunological product on the market without a written approval issued by the Secretary of State F31....
Extent Information
E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F29Sch. 1 para. 29(1) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(22)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F30Word in Sch. 1 para. 29(2) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(22)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F31Words in Sch. 1 para. 29(3) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(22)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
29.—(1) Before placing an immunological product on the market the holder of the marketing authorisation must either—
(a)notify the Secretary of State asking for written approval to do so; or
(b)if the holder has already received written approval from [F37a] member State permitting the release of the product, send a copy of that approval to the Secretary of State.
(2) If notified under sub-paragraph (1)(a) the Secretary of State must give or refuse a written approval as soon as is reasonably practicable.
(3) No person may place an immunological product on the market without a written approval issued by the Secretary of State or (if the approval was issued by [F38a] member State) without sending a copy of that approval to the Secretary of State.
Extent Information
E12This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F37Word in Sch. 1 para. 29(1)(b) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(iii)
F38Word in Sch. 1 para. 29(3) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(iii)
[F3230. The holder of a marketing authorisation must give to the Secretary of State on demand evidence that the holder has carried out all control tests required under the marketing authorisation, and the results of those tests.]
Textual Amendments
F32Sch. 1 para. 30 omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 50
31.—(1) A holder of a marketing authorisation must notify the Secretary of State when the veterinary medicinal product is first placed on the market in the United Kingdom, and the date on which it was placed on the market.
(2) A holder of a marketing authorisation who removes the veterinary medicinal product from the market in the United Kingdom must notify the Secretary of State at least two months (or a shorter period in exceptional circumstances) before doing so.
[F33(2A) A holder of a marketing authorisation who identifies a shortage of the veterinary medicinal product must notify the Secretary of State as soon as is reasonably practicable.
(2B) For the purposes of sub-paragraph (2A) a shortage of a veterinary medicinal product occurs when supply does not meet demand at a national level within the United Kingdom.]
(3) Upon request by the Secretary of State, the marketing authorisation holder must provide—
(a)all data relating to the volume of sales of the veterinary medicinal product by the holder; and
(b)any data in the holder’s possession relating to the number of prescriptions written for the product and the total volume supplied under those prescriptions.
Extent Information
E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F33Sch. 1 para. 31(2A)(2B) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 51
31.—(1) A holder of a marketing authorisation must notify the Secretary of State when the veterinary medicinal product is first placed on the market in [F39Northern Ireland], and the date on which it was placed on the market.
(2) A holder of a marketing authorisation who removes the veterinary medicinal product from the market in [F40Northern Ireland] must notify the Secretary of State at least two months (or a shorter period in exceptional circumstances) before doing so.
(3) Upon request by the Secretary of State, the marketing authorisation holder must provide—
(a)all data relating to the volume of sales of the veterinary medicinal product by the holder; and
(b)any data in the holder’s possession relating to the number of prescriptions written for the product and the total volume supplied under those prescriptions.
Extent Information
E13This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F39Words in Sch. 1 para. 31(1) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(iv)
F40Words in Sch. 1 para. 31(2) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(iv)
32. Subject to any power of revocation provided under these Regulations a marketing authorisation is valid indefinitely.]
Extent Information
E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F34Sch. 1 para. 32 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 52
32.—(1) A marketing authorisation is initially valid for five years.
(2) The authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance.
(3) An application for renewal must be made at least six months, and not more than nine months, before the marketing authorisation ceases to be valid.
(4) An applicant who applies for the renewal of the marketing authorisation must enclose a list of all documents concerning the product that the applicant has submitted to the Secretary of State since the marketing authorisation was granted.
(5) The Secretary of State may require the applicant to provide a copy of any of the listed documents at any time.
(6) Once renewed, the marketing authorisation is valid indefinitely unless, within five years of the renewal, the Secretary of State notifies the holder, on justified grounds relating to pharmacovigilance, that the authorisation will cease to be valid five years from the first renewal unless the holder applies for a further renewal.
(7) The further renewal is not time-limited.
(8) Any marketing authorisation granted under these Regulations that is not followed within three years of its granting by the actual placing on the market of the authorised veterinary medicinal product in [F41Northern Ireland] ceases to be valid.
(9) When a veterinary medicinal product authorised under these Regulations and previously placed on the market in [F42Northern Ireland] is not present on the market in [F42Northern Ireland] for a period of three consecutive years, its marketing authorisation ceases to be valid.
(10) The Secretary of State may, on human or animal health grounds, grant exemptions from sub-paragraphs (8) and (9).
Extent Information
E14This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F41Words in Sch. 1 para. 32(8) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(v)
F42Words in Sch. 1 para. 32(9) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(v)
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