Traduction de «Certificazione dei prodotti medicinali » (Italien → Anglais) :

(c) voluntary agricultural- product and farm certification schemes recognised by the Member States as meeting the Union best practice guidelines for the operation of voluntary certification schemes relating to agricultural products and foodstuffs.

(4) Article VI of the Agreement which provides for two separate product certification schemes (self-certification for products placed on the Union market and third-party certification for products placed on the United States market) should be taken into account.

(h)save to the extent covered by Article 3(5)(b) of this Regulation, proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products respectively.

save to the extent covered by Article 3(5)(b) of this Regulation, proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products respectively.

Given the unanimous adoption by the European Parliament on 3 May (R5-0230/2001) of Mrs Doyle’s report (A5-0119/2001 ) on the availability of veterinary medicinal products; given the urgent need to have optimal protection for the consumer; given the urgent need on welfare, therapeutic and economic grounds for veterinarians to have access to the widest range of veterinary products to treat all food-producing animals; given the Commission’s approval of the principle of extrapolating maximum residue limits established for some species to other species as a short term solution to the problem and given the commitment ma ...[+++]de by Commissioner Liikanen on the record in the parliamentary debate on veterinary medicinal products that he expected ‘legislative proposals to be finalised within a few months’;

31. Considers that the single market in pharmaceuticals is incomplete and that the consequent market distortions are causing wide disparities in patient access to needed medicines; is therefore of the opinion that progressive liberalisation of the pharmaceutical market is needed in order to improve patient choice and access to high-quality, safe, efficacious and cost-effective medicines and to ensure that these medicines are available throughout the European Union; calls on the Commission to include in its programmes a proposal for a framework directive for completing the internal market in pharmaceuticals by introducing a gradual econ ...[+++]omic liberalisation of all sectors of the industry and to propose legislation to amend Directive 65/65/EEC on medicinal products with a view to harmonising and recasting regulatory data protection, in the light of the December 1998 European Court of Justice decision on generics;