The Veterinary Medicines Regulations 2013

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

ScopeU.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 applicationE+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 [F3if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety].

[F4(1A) Sub-paragraph (1) does not apply to applications for—

(a)biological (including immunological) veterinary medicinal products;

(b)novel therapies.]

(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

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

Bibliographic applicationN.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

E6This 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 substancesU.K.

8.[F5(1)] 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.

[F6(2) Notwithstanding sub-paragraph (1) the applicant must provide a sound scientific justification based on valid therapeutic principles for the combination of active substances, including clinical data, which demonstrates the need for and contribution of all active substances at the moment of treatment.]

Application using existing dataU.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 [F7generic veterinary] medicinal productE+W+S

10.—(1) [F8Subject to sub-paragraphs (2A), (9) and (10) and paragraph 10A,] 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 [F9a generic of a] veterinary medicinal product already authorised in the [F10United Kingdom] [F11(“the reference veterinary medicinal product”), provided that the applicant provides data demonstrating the matters referred to in sub-paragraph (2)].

(2) For the purposes of this paragraph a product is [F12a generic of] an existing product if—

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

(b)it has the same pharmaceutical form [F13as the reference product]; and

[F14(c)bioequivalence with the reference product has been demonstrated]

[F15(2A) Sub-paragraph (1) does not apply to applications for biological (including immunological) veterinary medicinal products.]

(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 [F16European Medicines] Agency [F17or the Secretary of State] exempt the product.

F18(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F19(7) For the purposes of these Regulations, subject to sub-paragraph (8), the summary of product characteristics of a generic veterinary medicinal product must be essentially similar to the summary of product characteristics for the reference product.

(8) The requirement in sub-paragraph (7) does not apply in relation to those parts of the summary of product characteristics of the reference product that refer to indications or pharmaceutical forms which are covered by patents at the time when the generic veterinary medicinal product is authorised.

(9) Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the applicant must provide—

(a)administration site target animal tolerance data;

(b)in respect of products intended for administration to food-producing species only, residues depletion data from the site of administration.

(10) Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products containing antimicrobial or antiparasitic substances, the applicant must provide all available data (including published data) on the current level of resistance, together with a review of that data as it relates to target pathogens to the active substances concerned.

(11) An applicant must provide an environmental risk assessment for a generic veterinary medicinal product where—

(a)the marketing authorisation for the reference veterinary medicinal product was granted before 1st October 2005, and

(b)no marketing authorisation has been granted since 1st October 2005 in respect of a veterinary medicinal product which has the same active substance and pharmaceutical form as the reference veterinary medicinal product, and which is indicated for use in the same target species when administered at the same or a higher total dose,

unless the Secretary of State holds an environmental risk assessment for the reference veterinary medicinal product and has confirmed this to the applicant.]

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

Application for a pharmacologically equivalent medicinal productN.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 [F34a] member State but not in [F35Northern 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

E7This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F20Hybrid veterinary medicinal productsE+W+S

10A.  An applicant for a marketing authorisation must provide the results of relevant pre-clinical studies or clinical trials where—

(a)bioavailability studies are not capable of demonstrating bioequivalence between the veterinary medicinal product for which the authorisation is sought and a reference veterinary medicinal product for the purposes of paragraph 10; or

(b)the veterinary medicinal product for which the authorisation is sought is not pharmacologically equivalent to a reference veterinary medicinal product for the purposes of paragraph 10 as a result of a difference in relation to—

(i)the active substance or substances contained in the product;

(ii)the strength of the product;

(iii)the indications for use of the product;

(iv)the pharmaceutical form of the product;

(v)the route of administration of the product;

(vi)the withdrawal period for the product.]

Time limits for marketing authorisations granted under the procedure for a [F21generic veterinary medicinal] productE+W+S

11.—(1) This paragraph establishes the time limits relating to granting a marketing authorisation under the procedure for a [F22generic veterinary medicinal] 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.

[F23(3) The product may not be placed on the market until the end of the longest of the following periods which is relevant—

(a)subject to sub-paragraph (3A), 10 years in the case of a veterinary medicinal product authorised for major species;

(b)18 years in the case of a veterinary medicinal product authorised for bees; and

(c)14 years for a veterinary medicinal product authorised for all other species.

(3A) Where the product—

(a)is intended for administration to a major species; and

(b)contains an active substance which is an antimicrobial which has not been an active substance in a veterinary medicinal product previously subject to a marketing authorisation in Great Britain,

the period mentioned in sub-paragraph (3)(a) is 14 years.

(3B) Where a patent in relation to a reference product has lapsed, the summary of product characteristics of the relevant generic product must be updated in order to include the protected information.

(3C) Where, as a result of a variation to an existing marketing authorisation a product is accorded a new marketing authorisation number any relevant protection period applies in relation to that product.

(3D) In this regulation “major species” means cattle, sheep (for meat production), pigs, chickens, dogs and cats.]

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

Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent productN.I.

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 limitsE+W+S

12.F24(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F25(2) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation or for a variation to a marketing authorisation for a product, and within five years of the original marketing authorisation being granted, the marketing authorisation is extended to include an additional major species or a new antimicrobial product, the relevant protection period is extended by one year for each additional major species added to the marketing authorisation.

(2A) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation mentioned in sub-paragraph (2) and the marketing authorisation is extended to include an additional minor species, the relevant protection period is extended by four years.

(2B) Sub-paragraphs (2) and (2A) do not apply where the application to extend the marketing authorisation is made fewer than three years before the expiration of the protection period.]

(3) The total period may not exceed [F2618] years.

F27(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extension of time limitsN.I.

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.

[F28Time limits – supplementaryE+W+S

12A.(1) Subject to sub-paragraph (3), a study, residue test or pre-clinical study in relation to the establishment of residue limits submitted by an applicant in relation to an application for a marketing authorisation or a variation of a marketing authorisation may not be used for any other such application or variation until the period of five years from that submission has elapsed.

(2) Subject to sub-paragraph (3), a study, residue test or preclinical study submitted by an applicant for a marketing authorisation or a variation in a marketing authorisation which demonstrates a reduction in antimicrobial resistance in relation to a reference product may not be used for any other such application until a period of four years in addition to the relevant protection period has elapsed.

(3) Sub-paragraphs (1) and (2) do not apply where an applicant has obtained a written authorisation to access a study, residue test or pre-clinical study mentioned in the relevant sub-paragraph.]

Parallel importsE+W+S

F2913.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Parallel importsN.I.

13.—(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in [F36a] member State and imported into [F37Northern 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 [F38Northern Ireland].

(3) Other products must be therapeutically the same as a product authorised in [F39Northern 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 [F40Northern Ireland] appropriate to the type of product to be imported.

(7) If re-labelling is to take place in [F41Northern Ireland] the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in [F41Northern Ireland].

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

Specific batch control schemeE+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.

F30(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F31(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Specific batch control schemeN.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

E9This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Similar immunological productsU.K.

[F3215.  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 countryE+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 [F33in another] country.

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

Marketing a product authorised in another countryN.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 [F42a] member State or, if there is no such authorised product, authorised in a third country.

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

Textual Amendments