S.L. 437.47 ст. 13Derogation.

(1) By way of derogation from regulation 12(3)(j), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under regulation 5 for not less than eight years in a Member State or the European Union. A generic veterinary medicinal product authorized pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subregulation shall also apply when the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the Member State in which the reference medicinal product is or has been authorised. At the request of the Veterinary Services, the competent authority of the other Member State shall transmit, within a period of one month, confirmation that the reference medicinal product is or has been authorized together with the full composition of the reference product and if necessary other relevant documentation. However, the ten-year period provided for in the second paragraph shall be extended to thirteen years in the case of veterinary medicinal products for fish or bees or other species designated in accordance with the procedure referred to in Article 89(2) of European Union Council Directive 2004/28 EC.

(2) For the purposes of this regulation:

(a) "reference medicinal product" shall mean a product authorised within the meaning of regulation 5 in accordance with the provisions of regulation 12;

(b) "generic medicinal product" shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and, or efficacy. In such cases, additional information intended to provide proof of the safety and, or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies neednot be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

(3) In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in subregulation (2)( ) or where bio-equivalence cannot be b demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.

(4) Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in the Schedule and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided.

(5) In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance that has not been authorised in the European Union by 30 April 2004 the ten-year period provided for in the second paragraph of subregulation (1) shall be extended by one year for each extension of the marketing authorisation to another food-producing species, if it is authorised within the five years following the granting of the initial marketing authorisation. This period shall not, however, exceed a total of thirteen years, for a marketing authorisation for four or more food-producing species.

The extension of the ten-year period to eleven, twelve, or thirteen years for a veterinary medicinal product intended for food-producing species shall be granted only if the marketing authorisation holder also originally applied for determination of the maximum residue limits established for the species covered by the authorisation.

(6) Conducting the necessary studies, tests and trials with a view to the application of subregulations (1) to (5) and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products.