6 Amendments of Sylvana RAPTI related to 2008/0261(COD)
Amendment 68 #
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 87 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, working together with stakeholders, should be free to determine the particular aspects of medicines authentication which they consider most appropriate for their medicine distribution system, taking into account the safety features adopted pursuant to this Directive.
Amendment 117 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Furthermore, Member States should collaborate, making use of the services of Europol, to enforce the existing restrictions on the illegal internet supply of medicines.
Amendment 168 #
Proposal for a directive – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Directive 2001/83/EC
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
(2a) In Article 2, the following paragraph 3a is inserted after paragraph 3: 3a. Nothing in this Directive shall affect the right of Member States to restrict or prohibit the sale of prescription medicines over the internet.
Amendment 203 #
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
(o) safety features making it possible to ascertain identification authenticity of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.
Amendment 286 #
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. Member States shall ensure that the ownership and confidentiality of data generated by the use of safety features to authenticate medical products is respected.