56. Notes that e-commerce and the Internet are developing at such a pace, with ‘generations’ of technology growing shorter geometrically; believes therefore that attempts should be made to bring the EU’s regulatory response into line with current social and commercial requirements so that it does not become pointless through lagging behind and obstruct the full unlocking of the potential of the EU Member States’ CCI;

9. Notes that e-commerce and the Internet are developing at such a pace, with ‘generations’ of technology growing shorter geometrically, and therefore believes that attempts should be made to bring the Union’s regulatory response into line with current social and commercial requirements so that it does not become pointless through lagging behind and obstruct the full unlocking of the potential of the CCIs of the EU Member States;

4b. As from [insert date: 36 months after publication] all medicinal products subject to medical prescription other than radiopharmaceuticals must, from the time of the batch release pursuant to Article 51, carry a serialisation number that identifies the individual package unequivocally.

In this respect, Commissioner, the US Food and Drug Administration has so far recorded about 2 900 cases of toxic effects, including 104 deaths, principally due to the misuse of ephedrine, a drug that releases catecholamines, causes tachyarrhythmias and can lead to heart failure.

The provisions for the official release of batches of immunological medicinal products should be reviewed in order to take account of the improvement of the general system for monitoring the quality of medicinal products and to reflect technical and scientific progress, and also in order to make mutual recognition fully effective.

(3) Article 13(3) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(4) requires that detailed guidance be drawn up, in accordance with the guidelines on good manufacturing practice, on the elements to be taken into account when evaluating investigational medicinal products for human use with the object of releasing batches within the Community.