8 Amendments of Konstantinos POUPAKIS related to 2008/0261(COD)
Amendment 19 #
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, 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. 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.
Amendment 20 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
Amendment 25 #
Proposal for a directive – amending act
Recital 17
Recital 17
(17) In particular the Commission should be empowered to adopt measures regarding safety features that shall appear on the packaging of medicinal products subject to medical prescription and to adopt detailed rules for medicinal products introduced without being placed on the market. Since those measures are of general scope and are designed to amend non- essential elements by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 26 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Member States should cooperate with Europol, inter alia, in order to strengthen the application of existing restrictions regarding the illegal supply of medicinal products on the internet.
Amendment 34 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83(EC)
Article 54 – point o
Article 54 – point o
safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.’
Amendment 40 #
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
(4) 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. However, before proposing specific measures in accordance with point (o) of Article 54, the Commission shall undertake a public cost-benefit evaluation of existing safety features and consult the stakeholder parties involved in applying and using the safety features.
Amendment 45 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 4 – subparagraph 5
Article 54a – 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. Member States shall ensure that the ownership and confidentiality of the data resulting from the use of safety features with the object of demonstrating the authenticity of pharmaceutical products are respected.’
Amendment 56 #
Proposal for a directive – amending act
Article 2 – paragraph 2
Article 2 – paragraph 2
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. This Directive shall not affect the right of Member States to restrict or ban the sale of prescription drugs via the internet.