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SCHEDULE 1U.K.Marketing authorisations [F1in Great Britain] [F2in Northern Ireland]

Textual Amendments

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

Application for a [F3generic veterinary] medicinal productE+W+S

10.—(1) [F4Subject 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 [F5a generic of a] veterinary medicinal product already authorised in the [F6United Kingdom] [F7(“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 [F8a 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 [F9as the reference product]; and

[F10(c)bioequivalence with the reference product has been demonstrated]

[F11(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 [F12European Medicines] Agency [F13or the Secretary of State] exempt the product.

F14(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F15(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

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

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 [F16a] member State but not in [F17Northern 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

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments