Activities of Marina YANNAKOUDAKIS related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Amendments (8)
Amendment 80 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Safety features will be grouped so as to reflect the particularities of certain products or categories of products. They will be considered equivalent when they offer the same or a higher level of efficiency for ascertaining identification, authentication, traceability and absence of tampering, as well as the same level of technical difficulty for duplication. When removing, replacing or covering the safety feature, this point should also be applicable to the new safety feature.
Amendment 192 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – point b
Article 46b – paragraph 2 – point b
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community, and that the plant is subject to strict and transparent control and enforcement ensuring that those good manufacturing practices cannot be circumvented.
Amendment 210 #
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 and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI. This point shall apply to all generic medicines subject to medicinal prescription.
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.
Amendment 333 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)
Title VII a (new) – Article 85 c (new)
(14a) The following Title VIIa and Article 85c are inserted after Article 85b: 'TITLE VIIa INTERNET SALES Article 85c 1. The Commission shall adopt an EU logo for the front page of internet pharmacy sites, helping the public to identify whether a website offering to sell medicinal products is connected to a registered pharmacy. The logo shall be tamper-proof and incorporate features that help prevent it from being copied and it shall also be linked to a secure central website at Member State level, to be established by the Member State, that allows the visitor to check the authenticity of the logo and that provides background information on the risks related to buying medicinal products on the internet. Those measures shall be adopted by the Commission by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c. 2. Member States shall take the appropriate measures to ensure that all registered pharmacy internet sites linked to pharmacies within their territory display the EU logo referred to in paragraph 1 and to prevent non-registered pharmacy internet sites from using the logo and linking to the central website referred to in paragraph 1.'
Amendment 337 #
Proposal for a directive – amending act
Article 1 – point 14 b (new)
Article 1 – point 14 b (new)
Directive 2001/83/EC
Article 85 d (new)
Article 85 d (new)
(14b) The following Article 85d is inserted: 'Article 85d 1. The Commission shall adopt measures to increase awareness among the general public on the risks related to purchasing medicinal products on the internet, which may include: - general information campaigns, in cooperation with the Member States; - easily accessible lists of accredited e- pharmacies Those measures shall be adopted by the Commission by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c.'
Amendment 362 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118b b (new)
Article 118b b (new)
Article 118bb The Commission shall establish a network between the Commission, EMEA and the competent authorities in the Member States to ensure the exchange of information on the measures taken to combat the falsification of medicinal products, including on the penalties systems in place. This network shall aim at defining best practices and shall contribute to increased cooperation in the area of prevention and enforcement. The Commission, EMEA and the competent authorities in the Member States shall report to this network on the actions they have undertaken.
Amendment 371 #
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. Not later than two years after the date of entry into force of this Directive, the internet pharmacy safety features included in this legislation shall be in place. The Commission shall also submit to the European Parliament and the Council an assessment report on the application of the safety features, including any related to internet pharmacies, 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 medicines in the legal supply chain in Europe. The report should include an assessment of the safety features of other categories of medicines and of internet pharmacies, including medicinal products not subject to medical prescription as defined in Title VI of Directive 2001/83/EC. If appropriate the Commission shall present the proposals to the European Parliament and Council within a year of the publication of this report.