8 Amendments of János ÁDER related to 2008/0261(COD)
Amendment 254 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – introductory part
Article 54a – paragraph 4 – subparagraph 3 – introductory part
When adopting those measures, the Commission shall consider the risk related to products or categories ofescription products and at least all of the following:
Amendment 256 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point a
Article 54a – paragraph 4 – subparagraph 3 – point a
Amendment 260 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point b
Article 54a – paragraph 4 – subparagraph 3 – point b
(b) The number of incidences of falsifications in third countries and within the Communityand frequency of past incidences of reported cases of counterfeited medicines within the Union and the evolution of those incidences in the past;
Amendment 263 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point c
Article 54a – paragraph 4 – subparagraph 3 – point c
Amendment 265 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point d
Article 54a – paragraph 4 – subparagraph 3 – point d
Amendment 267 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point e
Article 54a – paragraph 4 – subparagraph 3 – point e
Amendment 272 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 4
Article 54a – paragraph 4 – subparagraph 4
On the basis of these criteria, the requirementmeasures referred to in points (ao) and (b) ofof Article 54 and the requirements referred to in paragraph (1) and (2) of this Article may be waived for certain products or product categoriesshall be applied compulsorily only to those products or product categories found to pose a high risk of falsification, and be waived or voluntary for those products or product categories that do not pose a high risk of falsification such as, generic medicinal products authorised in accordance with Article 10.
Amendment 279 #
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 ofat least all of the following: (a) the cost-effectiveness of the system, in order to guarantee that any measure that is applied is based on a cost-benefit analysis; (b) the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned; (c) the independence of the system and the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights and personal data.