15 Amendments of Frédérique RIES related to 2008/0261(COD)
Amendment 56 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) Any actor in the supply chain who packageslabels or packages medicinal products or inserts changes to the labelling or packaging of medicinal products has to be a holder of a manufacturing authorization. In order for the safety features to be effective, the manufacturing authorization holder should only be permitted to remove, replace or cover these features under strict conditions. The strict conditions should provide adequate safeguards against falsified products entering the distribution chain and also reflect a strict duty of care of these manufacturing authorisation holders towards the original manufacturer and the marketing authorisation holder of the products and to consumers of the products.
Amendment 57 #
Proposal for a directive – amending act
Recital 4 a (new)
Recital 4 a (new)
(4a) The European Union should support the drafting of an international agreement stepping up the penalties for falsifying medicinal product, and of an additional protocol to the Palermo Convention against Transnational Organised Crime.
Amendment 62 #
Proposal for a directive – amending act
Recital 17 a (new)
Recital 17 a (new)
(17a) In order to identify each individual package of medicinal products subject to medical prescription other than radiopharmaceuticals, certain product characteristics (i.e. product code, expiry date, lot number) should appear amongst the safety features. This information should be available in a machine-readable format which is harmonised across Europe using an international coding standard.
Amendment 88 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 2 – point c a (new)
Article 54 a – paragraph 2 – point c a (new)
(ca) The manufacturing authorisation holder clearly indicates on the outer packaging when original safety features have been partly or fully removed or covered up;
Amendment 90 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 3
Article 54 a – paragraph 3
(3) Manufacturing authorisation holders shall be liable for damages in accordance with Council Directive 85/374/EEC caused by medicinal products which are falsified in terms of their identityreferred to in paragraph 2 of this Article shall be considered producers under Council Directive 85/374/EEC. They shall be liable for damages caused by medicinal products which are falsified in terms of their identity to the original manufacturer, to the holder of the marketing authorisation and to consumers.
Amendment 92 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) Any actor in the supply chain who packageslabels or packages medicinal products or inserts changes to the labelling or packaging of medicinal products has to be a holder of a manufacturing authorization. In order for the safety features to be effective, the manufacturing authorization holder should only be permitted to remove, replace or cover these features under strict conditions. The strict conditions should provide adequate safeguards against falsified products entering the distribution chain and also reflect a strict duty of care of those manufacturing authorisation holders towards the original manufacturer and the marketing authorisation holder of the products and to consumers of the products.
Amendment 99 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) The Commission and the Member States should adopt measures such as awareness campaigns to inform the public more fully of the risks of purchasing pharmaceutical products online.
Amendment 99 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 a (new)
Article 54 a – paragraph 4 a (new)
As from [insert concrete date 36 months after publication] all medicinal products subject to medical prescription other than radiopharmaceuticals must, from the time of the batch release pursuant to Article 51, carry a serialisation number that identifies the individual package unequivocally. The serial number should be integrated into an internationally recognised and harmonised coding standard.
Amendment 114 #
Proposal for a directive – amending act
Recital 17 a (new)
Recital 17 a (new)
(17a) 36 months at the latest after entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level. Hence, each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.
Amendment 211 #
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 medicinal prescription as defined in Title VI. 36 months at the latest after entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level. Hence, each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.’
Amendment 240 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point c a (new)
Article 54a – paragraph 2 – point c a (new)
(c a) Manufacturing authorisation holders clearly indicate on the outer packaging where the original safety features have been partly or fully removed or covered up.
Amendment 244 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 3
Article 54a – paragraph 3
Amendment 360 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118b
Article 118b
1. Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.’ In that connection, Member States, working in coordination with healthcare professionals, including the pharmaceuticals industry, shall take the necessary measures to encourage training for customs officers to help them deal with the phenomenon of falsified medicinal products. That coordination shall be strengthened by international cooperation programmes conducted by the Commission. 2. Member States shall take the necessary measures to ensure that customs officers are provided with the resources they need and shall supply, in particular, the technology essential to the work of detecting falsified medicinal products. 3. The Commission shall draw up a report on the relevant action taken 36 months after the publication of this Directive.
Amendment 364 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118c a (new)
Article 118c a (new)
Article 118c a The Commission, working with the Member States, shall support the drafting, under the auspices of the United Nations, of an international convention on the combating of the falsification of medicinal products, with a view to ensuring that stiffer penalties are imposed on those guilty of such falsification.
Amendment 366 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118c c (new)
Article 118c c (new)
Article 118c c The Commission, working closely with the Member States, shall organise an information campaign aimed at the general public on the dangers of counterfeit medicinal products, including the Internet-related risks.