Activities of Regina BASTOS related to 2008/0261(COD)
Plenary speeches (2)
Explanations of vote
Falsified medicinal products (debate)
Amendments (9)
Amendment 13 #
Proposal for a directive – amending act
Recital 3 a (new)
Recital 3 a (new)
(3a) Experience shows that, when consumers purchase medicinal products on the internet, they cannot always verify the authenticity of the source. The Commission, in coordination with the EMA and the Member States, should launch campaigns to raise awareness among consumers of the risks they run in obtaining medicines over the internet from unlicensed sites. Further, the Commission should report every two years to the European Parliament and to the Council on the impact of the measures provided for by this Directive and the need for further harmonisation, with particular regard to the sale of medicines on the internet, whereby the decision on whether or not to authorise the sale of medicines on the internet rests with each Member State.
Amendment 14 #
Proposal for a directive – amending act
Recital 3 b (new)
Recital 3 b (new)
Amendment 15 #
Proposal for a directive – amending act
Recital 3 c (new)
Recital 3 c (new)
(3c) Every two years the Commission should submit a comprehensive evaluation of the situation regarding 'over-the-counter' medicinal products (OTCs), focusing on the question of whether and in what form OTCs should be included in the scope of this Directive.
Amendment 17 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) Today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in Directive 2001/83/EC. In order to ensure reliability in the distribution chain, pharmaceutical legislation should address all actors in the distribution chain: this includes not only distributors who procure, hold, store and supply products, but also persons who are involved in transactions without handling the products. TheyAll actors should be submittedject to proportionate rules in order to exclude, by all practical means, the possibility that medicinal products which are falsified in relation to their identity, history or source mighto enter the legal supply chain in the Community.
Amendment 18 #
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. Safety features (other than serialisation numbering) should be grouped in categories based on equivalence and, in general, manufacturing authorization holders should adopt a specific feature or features to use within a particular category. Safety features should be considered equivalent when they ensure the same level of protection in terms of ascertaining authenticity, absence of tampering and, where relevant, identification, and present the same level of technical difficulty of duplication.
Amendment 30 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83(EC)
Article 1 – point 5 a (new)
Article 1 – point 5 a (new)
-1) In Article 1, the following point 5a is inserted after point 5: "5a. Falsified medicinal product: Any medicinal product that has been intentionally or deliberately falsified in relation to its: (a) identity, including its packaging, labelling, name and composition in terms of both ingredients, including excipients and active ingredients, and the dosage thereof; and/or (b) source, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder; and/or (c) history, including the registers and documents enabling the distribution chain to be identified. The Commission shall be empowered to update this definition on the basis of technical and scientific progress and/or international agreements."
Amendment 37 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 2 – introductory part
Article 54a – paragraph 2 – introductory part
(2) The safety features referred to in point (o) of Article 54 shall not be partly or fully removed or covered-up, unless the identification, authenticity and traceability of the medicinal products are guaranteed and the following conditions are fulfilled:
Amendment 43 #
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, particularly within the CommunityUnion;
Amendment 44 #
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 – subparagraph 1a (new)
Article 54a – paragraph 4 – subparagraph 3 – point e – subparagraph 1a (new)
The safety features (other than serialisation numbering) shall be imposed through the identification of one or more categories of feature that must be used for particular products or categories of product. The Commission’s Pharmaceutical Committee shall define categories comprising safety features offering equivalent efficiency and effectiveness, and features from the same category shall then be considered equivalent for the purposes of paragraph (2) (b) of this Article. Manufacturing authorization holders shall have discretion as to which specific feature or features to use within a category, unless the Commission specifies reasons for requiring that a particular safety feature be used.