S.L. 458.34 Art. 7Details to be provided.

(1) (a) (i) By way of derogation from regulation 5(1)(c)(x), 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 pre-clinical tests and of 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 4(1) for not less than eight years in a Member State or in the Community. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product: Provided that the said ten-year period shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.

(ii) Subregulation (1)(a)(i) shall also apply if the reference medicinal product was not authorised in Malta. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the Licensing Authority, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised, together with the full composition of the reference product and if necessary other relevant documentation: Provided that the Licensing Authority shall within one month provide any information requested by the competent authority of another Member State in respect of a reference medicinal product authorised in Malta: Provided further that for the purposes of this regulation: ''reference medicinal product'' means a medicinal product authorised under regulation 4(1), in accordance with the provisions of regulation 5 or authorised under Article 8 of Directive 2001/83/EC as amended; ''generic medicinal product'' means 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 providing 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 need not 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.

(b) In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided above or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in any active substance, therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.

(c) Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological 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 Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided.

(d) In addition to the provisions laid down in paragraph (a), where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication.

(e) Conducting the necessary studies and trials with a view to the application of paragraphs (a), (b), and (c) and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.

(f) The periods of protection provided for in paragraphs (a), (b), (c) and (d) shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date of coming into force of these regulations.

(2) By way of derogation from regulation 5(1)(c)(x), 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 pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature.

(3) In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with regulation 5(1)(c)(x), but it shall not be necessary to provide scientific references relating to each individual active substance.

(4) Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.