Activities of Holger KRAHMER related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Amendments (20)
Amendment 75 #
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, mandatory 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. No later than five years after the date of entry into force of this Directive, the Commission should submit to the European Parliament and to the Council an assessment report on the application of the safety features 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 to other categories of medicines, including medicinal products not subject to medical prescription as defined in Title VI of Directive 2001/83/EC.
Amendment 97 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should have their attention drawn to the risks which arise when medicinal products are ordered from illegal suppliers. In particular, public information measures should be promoted in the Member States and throughout Europe. The Commission and Member States should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the Internet.
Amendment 115 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) The Member States should cooperate to enforce existing restrictions on illegal trading in medicinal products, including by means of Europol.
Amendment 123 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - introductory part (new)
Article 1 – point 2 a - paragraph 1 - introductory part (new)
-1) In Article 1, the following point 2a is inserted after point 2: 2a. Falsified medicinal product: Any medicinal product, ingredient, excipient or component thereof which is deliberately and / or fraudulently misrepresented with respect to:
Amendment 133 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point a (new)
Article 1 – point 2 a - paragraph 1 - point a (new)
(a) its identity, including its packaging and labelling, name, composition in respect of any of its components and strength; and/or
Amendment 140 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point b (new)
Article 1 – point 2 a - paragraph 1 - point b (new)
(b) its source, including the manufacturer, country of manufacturing, country of origin, marketing authorisation holder; and/or
Amendment 149 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point c (new)
Article 1 – point 2 a - paragraph 1 - point c (new)
Amendment 155 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 2 (new)
Article 1 – point 2 a - paragraph 2 (new)
This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights.
Amendment 161 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 1 – point 17 a
Article 1 – point 17 a
‘17a. Trading of medicinal products: 'All activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products, or billing or brokering medicinal producactive pharmaceutical ingredients or billing medicinal products or active pharmaceutical ingredients, apart from supplying medicinal productsthem to the public, and not falling under the definition of wholesale distribution.’
Amendment 165 #
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 1 – point 17 b (new)
Article 1 – point 17 b (new)
(1a) In Article 1, the following point 17b is inserted after point 17a: 17b. Brokering: All activities in relation to sale or purchase of medicinal products or active pharmaceutical ingredients, except for retail supply and wholesale distribution as defined in point 17 of this Article, that do not include physical handling and that consist of mediating independently and on behalf of another legal or natural person.
Amendment 172 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State.’
Amendment 195 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 47 – paragraph 3
Article 47 – paragraph 3
‘The principles of good manufacturing and distribution practices for active substances used as starting materials referred to in point (f) of Article 46 and in Article 46b shall be adopted in the form of detailed guidelines.’
Amendment 197 #
Proposal for a directive – amending act
Article 1 - point 7
Article 1 - point 7
Directive 2001/83/EC
Article 52a
Article 52a
Importers and, manufacturers and distributors of active substances used as starting materials established in the Community shall notify their address to the competent authority of the Member State where they are established.
Amendment 243 #
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 253 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 2 a (new)
Article 54a – paragraph 4 – subparagraph 2 a (new)
Before the Commission adopts a measure to implement point (o) of Article 54, it shall perform a public impact assessment evaluating the costs and benefits of the existing safety features and consult all parties involved in the implementation and use of such safety features.
Amendment 259 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 3 – point a a (new)
Article 54 a – paragraph 4 – subparagraph 3 – point a a (new)
(aa) the complexity of the supply chain;
Amendment 270 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 3 a (new)
Article 54 a – paragraph 4 – subparagraph 3 a (new)
The safety features (other than serialisation numbering) shall be imposed through identification of one or more categories of features that must be used for particular products or categories of products. The Commission’s Pharmaceutical Committee shall define categories comprising safety features offering equivalent efficiency and effectiveness, and features from the same category will then be considered equivalent for purposes of paragraph 2(b). Manufacturing authorisation holders may select which specific feature or features to use within a category, unless the Commission specifies reasons for requiring that a particular safety feature be used.
Amendment 274 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 4
Article 54 a – paragraph 4 – subparagraph 4
On the basis of these criteria, the requirements referred to in points (a) and (b) of paragraph (1) of this Article may be waived for certain products or product categories.
Amendment 284 #
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.
Amendment 340 #
Proposal for a directive – amending act
Article 1 – point 14 e (new)
Article 1 – point 14 e (new)
Directive 2001/83/EC
Article 88a a (new)
Article 88a a (new)
(14e) The following Article is inserted: 'Article 88aa Member States, in cooperation with the Commission and after consultation with representatives of stakeholders, shall devise an information strategy relating to the safety of consignments of medicinal products. The strategy shall take account of the various national legal provisions concerning the supply of medicinal products and the risks associated with certain types of supply of medicinal products and with illegal trading on the internet.'