Activities of Horst SCHNELLHARDT related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Amendments (5)
Amendment 107 #
Proposal for a directive – amending act
Recital 14 a (new)
Recital 14 a (new)
(14a) Counterfeit medicinal products are often found to have been supplied in response to orders placed over the Internet. In accordance with the provisions of the Treaty, particularly Article 168 of the TFEU, Member States are responsible for regulating the marketing of medicinal products at the last level of trade, particularly in pharmacies. This also includes regulating the marketing of medicinal products by mail order and over the Internet. The case law of the Court of Justice permits Member States to impose an absolute ban on the supply of prescription medicines by mail order, in accordance with the wide margin of discretion which they enjoy on account of the dangers associated with this method of marketing.
Amendment 110 #
Proposal for a directive – amending act
Recital 15 a (new)
Recital 15 a (new)
(15a) It is necessary for the operation of the internal market to establish EU-wide harmonised safety features for medicinal products. The technical implementation of these features and the design of the test methods should, however, be left to the Member States in accordance with the principle of subsidiarity.
Amendment 232 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b
Article 54a – paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without opening the immediate packaging as defined in Article 1(23). To this effect, the manufacturing authorisation holder shall produce a new outer carton replicating all relevant product and trademark information and subject to carrying safety features as required by Article 54(o); original cartons shall be destroyed;
Amendment 285 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5
Article 54 a – paragraph 4 – subparagraph 5
The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights. It has to be ensured that no collection or commercial processing of data takes place that would enable a link to be made between the medicinal products supplied and the corresponding patients or pharmacies.’
Amendment 320 #
Proposal for a directive – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Directive 2001/83/EC
Article 80 – point i – paragraph 2
Article 80 – point i – paragraph 2
Moreover, in cases where these infringements or suspected infringements relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.’ In the same way, the holder of the marketing authorisation or the trademark shall inform other supply chain operators in cases where it is suspected that falsified products have entered the legal supply chain.