Translation of "Point final moyen thérapeutique " (French → English) :

3. In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be 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.

19. Takes the view that, in terms of democratic legitimacy, a positive Statement of Assurance(DAS) by the ECA on the reliability of the Community's accounts and on the legality and regularity of underlying transactions is of paramount importance; considers that such a development would undoubtedly positively reflect on the Union's choices over the spending plans for the mid-term; Expects therefore the Commission while preparing for the new financial framework to be put in place for the period after 2007, to deploy all efforts necessary, through the acceleration of its internal reform and a closer co-ordination with the Member States in the context of shared management , in order to ensure that a positive DAS be given before a ...[+++]final decision is taken on the proposed new financial framework;

3. In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in 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 pre-clinical tests or clinical trials shall be provided.

3. In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be 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.

Distributors may do so by means of alternative arrangements, such as by accepting the waste at the point of purchase or delivery or by means of equivalent arrangements with third parties acting on their behalf, provided that returning the WEEE remains free of charge and is not made more difficult for the final holder.

In particular, they may ensure end-to-end connectivity by imposing proportionate obligations on undertakings that control access to end-users. Control of means of access may entail ownership or control of the physical link to the end-user (either fixed or mobile), and/or the ability to change or withdraw the national number or numbers needed to access an end-user's network termination point.