2 Amendments of Theodoros SKYLAKAKIS related to 2008/0261(COD)
Amendment 77 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, mandatory safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines and excipients. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated. No later than five years after the date of entry into force of this Directive, the Commission should submit to the European Parliament and to the Council an assessment report on the application of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC and their estimated contribution to the reduction of the number of falsified medicinal products in the legal supply chain in Europe. No later than 18 months after the date of entry into force of this Directive, the Commission should submit an assessment report on the safety features of over-the-counter medicinal products in accordance with Title VI of Directive 2001/83/ΕC.
Amendment 246 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1
Article 54a – paragraph 4 – subparagraph 1
The Commission shall adopt the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article. Before specific measures are proposed in accordance with point (o) of Article 54, the Commission shall carry out a public impact assessment of the costs and benefits of existing safety features, as well as a consultation with the parties involved in the implementation and use of such safety features, so as to demonstrate the effectiveness of the specific measures compared with existing national arrangements.