The Veterinary Medicines Regulations 2013

PART 2 U.K. Derogations from some of the requirements in Part 1

Scope U.K.

6.  This Part provides for applications for marketing authorisations in which not all the information required in Part 1 is required, but for the avoidance of doubt any applicant may apply for a marketing authorisation using Part 1 if the applicant wishes to do so.

Bibliographic application E+W+S

7.—(1) An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the active substance of the veterinary medicinal product has been in an authorised veterinary medicinal product for that species F3 ... for at least ten years, and the applicant provides appropriate scientific literature to demonstrate this.

(2) The applicant may use any publicly available document.

(3) If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of three years from the grant of the authorisation for the additional species.

Extent Information

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

Textual Amendments

F3 Words in Sch. 1 para. 7(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(12) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Bibliographic application N.I.

7.—(1) An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the active substance of the veterinary medicinal product has been in an authorised veterinary medicinal product for that species in the Community for at least ten years, and the applicant provides appropriate scientific literature to demonstrate this.

(2) The applicant may use any publicly available document.

(3) If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of three years from the grant of the authorisation for the additional species.

Extent Information

E6 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Application for a product using a new combination of active substances U.K.

8.  If an application is for a veterinary medicinal product containing active substances already used in an authorised veterinary medicinal product but not previously used in that combination in a veterinary medicinal product, the applicant need not provide the safety and efficacy data for the individual active substances.

Application using existing data U.K.

9.  If the Secretary of State has granted a marketing authorisation, the Secretary of State may, with the permission of the holder, use the data submitted in support of that marketing authorisation when assessing an application for another marketing authorisation.

Application for a pharmacologically equivalent medicinal product E+W+S

10.—(1) An applicant need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant can demonstrate that the veterinary medicinal product is pharmacologically equivalent to a veterinary medicinal product already authorised in the [F4 United Kingdom].

(2) For the purposes of this paragraph a product is pharmacologically equivalent to an existing product if—

(a) it has the same qualitative and quantitative composition in active substances;

(b) it has the same pharmaceutical form; and

(c) bioequivalence has been demonstrated by means of appropriate bioavailability studies.

(3) For the purposes of this paragraph—

(a) the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and

(b) if they do differ significantly in properties with regard to efficacy or safety, additional information intended to provide proof of the safety or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant.

(4) Different immediate-release oral pharmaceutical forms are regarded as the same pharmaceutical form.

(5) Bioavailability studies are not required if the bioequivalence guidelines produced by the [F5 European Medicines] Agency exempt the product.

(6) In the case of a reference product authorised in another member State but not in the United Kingdom, the Secretary of State must be satisfied that the risk-benefit balance of the original product is appropriate for the product to be placed on the market in the United Kingdom, and if the data provided under Article 13, third paragraph of Directive 2001/82/EC by the member State in which the product is authorised are insufficient for the Secretary of State to be satisfied of this, the Secretary of State may notify the applicant and require the applicant to provide further data.

Extent Information

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

Textual Amendments

F4 Words in Sch. 1 para. 10(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(13)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Sch. 1 para. 10(5) 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(13)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Application for a pharmacologically equivalent medicinal product N.I.

10.—(1) An applicant need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant can demonstrate that the veterinary medicinal product is pharmacologically equivalent to a veterinary medicinal product already authorised in the Community.

(2) For the purposes of this paragraph a product is pharmacologically equivalent to an existing product if—

(a) it has the same qualitative and quantitative composition in active substances;

(b) it has the same pharmaceutical form; and

(c) bioequivalence has been demonstrated by means of appropriate bioavailability studies.

(3) For the purposes of this paragraph—

(a) the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and

(b) if they do differ significantly in properties with regard to efficacy or safety, additional information intended to provide proof of the safety or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant.

(4) Different immediate-release oral pharmaceutical forms are regarded as the same pharmaceutical form.

(5) Bioavailability studies are not required if the bioequivalence guidelines produced by the Agency exempt the product.

(6) In the case of a reference product authorised in [F11 a] member State but not in [F12 Northern Ireland], the Secretary of State must be satisfied that the risk-benefit balance of the original product is appropriate for the product to be placed on the market in the United Kingdom, and if the data provided under Article 13, third paragraph of Directive 2001/82/EC by the member State in which the product is authorised are insufficient for the Secretary of State to be satisfied of this, the Secretary of State may notify the applicant and require the applicant to provide further data.

Extent Information

E7 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F11 Word in Sch. 1 para. 10(6) 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)(c)(i)

F12 Words in Sch. 1 para. 10(6) 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)(c)(ii)

Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product U.K.

11.—(1) This paragraph establishes the time limits relating to granting a marketing authorisation under the procedure for a pharmacologically equivalent product.

(2) An application for a marketing authorisation cannot be made until two years before the product may be placed on the market in accordance with this paragraph.

(3) The product may not be placed on the market until ten years (or, in the case of medicinal products for fish or bees where the application for a marketing authorisation was submitted after 30th October 2005, thirteen years) have elapsed from the initial authorisation of the reference product.

(4) Time limits in this paragraph are calculated from the first grant of the marketing authorisation for the reference product.

Extension of time limits U.K.

12.—(1) This paragraph applies in relation to veterinary medicinal products that—

(a) are intended for administration to food-producing species; and

(b) contain a new active substance that was not authorised in the Community by 30th April 2004.

(2) If a person submitted an application for a marketing authorisation for a product on or after 30th October 2005, and within 5 years of the original marketing authorisation being granted, the marketing authorisation is extended to include additional food-producing species, the ten-year protection period is extended by one year for each additional food-producing species added to the marketing authorisation.

(3) The total period may not exceed 13 years.

(4) The extension applies only if the marketing authorisation holder originally applied for determination of the maximum residue limits for the active substance.

Parallel imports E+W+S

13.—(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in another [F6 country] and imported into the United Kingdom from that [F6 country] in accordance with this paragraph without the data required in Part 1 if the applicant can demonstrate compliance with this paragraph.

(2) If the product is for a food-producing species it must be identical to a product authorised in the United Kingdom.

(3) Other products must be therapeutically the same as a product authorised in the United Kingdom unless the importer can justify any differences.

F7 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The applicant must be established within the [F8 United Kingdom].

(6) The applicant must hold (or have a contract with the holder of) a wholesale dealer’s authorisation in the United Kingdom appropriate to the type of product to be imported.

(7) If re-labelling is to take place in the United Kingdom the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in the United Kingdom.

Extent Information

E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F6 Word in Sch. 1 para. 13(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(15)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F7 Sch. 1 para. 13(4) 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(15)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Sch. 1 para. 13(5) 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(15)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Parallel imports N.I.

13.—(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in [F13 a] member State and imported into [F14 Northern Ireland] from that member State in accordance with this paragraph without the data required in Part 1 if the applicant can demonstrate compliance with this paragraph.

(2) If the product is for a food-producing species it must be identical to a product authorised in [F15 Northern Ireland].

(3) Other products must be therapeutically the same as a product authorised in [F16 Northern Ireland] unless the importer can justify any differences.

(4) The member State from which it is imported must have authorised the product in accordance with Directive 2001/82/EC.

(5) The applicant must be established within the Community.

(6) The applicant must hold (or have a contract with the holder of) a wholesale dealer’s authorisation in [F17 Northern Ireland] appropriate to the type of product to be imported.

(7) If re-labelling is to take place in [F18 Northern Ireland] the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in [F18 Northern Ireland].

Extent Information

E8 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F13 Word in Sch. 1 para. 13(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)(d)(i)

F14 Words in Sch. 1 para. 13(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)(d)(ii)

F15 Words in Sch. 1 para. 13(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)(d)(ii)

F16 Words in Sch. 1 para. 13(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)(d)(ii)

F17 Words in Sch. 1 para. 13(6) 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)(d)(ii)

F18 Words in Sch. 1 para. 13(7) 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)(d)(ii)

Specific batch control scheme E+W+S

14.—(1) Where a veterinary medicinal product (other than a biological veterinary medicinal product) has been granted a marketing authorisation or an animal test certificate, and any starting material (active substance, excipient or packaging) or any batch of the product does not fully meet the requirements of the authorisation or animal test certificate, the holder may apply to the Secretary of State to place one or more batches on the market notwithstanding this.

(2) The Secretary of State may authorise the placing on the market on being satisfied that the safety, quality and efficacy of the product are not compromised, and that in all the circumstances of the case the product should be placed on the market.

F9 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) In this paragraph a biological veterinary medicinal product is a veterinary medicinal product, the active substance of which is a biological substance; and a biological substance is a substance that is produced by or extracted from a biological source and for which a combination of physico-chemical-biological testing and the production process and its control is needed for its characterisation and the determination of its quality.

Extent Information

E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F9 Sch. 1 para. 14(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(16) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Specific batch control scheme N.I.

14.—(1) Where a veterinary medicinal product (other than a biological veterinary medicinal product) has been granted a marketing authorisation or an animal test certificate, and any starting material (active substance, excipient or packaging) or any batch of the product does not fully meet the requirements of the authorisation or animal test certificate, the holder may apply to the Secretary of State to place one or more batches on the market notwithstanding this.

(2) The Secretary of State may authorise the placing on the market on being satisfied that the safety, quality and efficacy of the product are not compromised, and that in all the circumstances of the case the product should be placed on the market.

(3) This paragraph does not apply in relation to a product recognised in more than one member State.

(4) In this paragraph a biological veterinary medicinal product is a veterinary medicinal product, the active substance of which is a biological substance; and a biological substance is a substance that is produced by or extracted from a biological source and for which a combination of physico-chemical-biological testing and the production process and its control is needed for its characterisation and the determination of its quality.

Extent Information

E9 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Similar immunological products U.K.

15.  Where an immunological veterinary medicinal product is pharmacologically equivalent to a reference product other than differences in raw materials or in the manufacturing process, the results of the appropriate pre-clinical tests or clinical trials must be provided, but the applicant need not provide the results of safety tests or residue tests.

Marketing a product authorised in another country E+W+S

16.  Where the health situation so requires, the Secretary of State may authorise the placing on the market of a veterinary medicinal product that has been authorised [F10 in another] country.

Extent Information

E5 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F10 Words in Sch. 1 para. 16 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(17) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Marketing a product authorised in another country N.I.

16.  Where the health situation so requires, the Secretary of State may authorise the placing on the market of a veterinary medicinal product that has been authorised by [F19 a] member State or, if there is no such authorised product, authorised in a third country.

Extent Information

E10 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F19 Word in Sch. 1 para. 16 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)(e)