Activities of Dagmar ROTH-BEHRENDT related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Amendments (8)
Amendment 74 #
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 178 #
Proposal for a directive – amending act
Article 1 – point 3 – point a a (new)
Article 1 – point 3 – point a a (new)
Directive 2001/83/EC
Article 46 – point f – subparagraph 2
Article 46 – point f – subparagraph 2
(aa) The second subparagraph of point (f) is replaced by the following: The Commission shall establish, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, a list of certain categories of excipients identified on a risk-based approach taking into account their source and their intended use. For these categories of excipients, the manufacturer shall apply the appropriate good manufacturing practices on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the second paragraph of Article 47, taking into account other suitable quality system requirements, and document this.
Amendment 191 #
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 control and enforcement, including repeated and unannounced inspections, ensuring that those good manufacturing practices cannot be circumvented.
Amendment 231 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b
Article 54a – paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without openingany changes to the immediate packaging as defined in Article 1(23) other than for the purposes set out in Article 55;
Amendment 276 #
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)
4a. By five years after the date of entry into force of the implementing measure of this Article, 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 and their contribution to the reduction of the number of falsified medicines in the legal supply chain in the Union and the potential benefits of alternative technologies and the possibilities for authentication of individual dosage forms.
Amendment 296 #
Proposal for a directive – amending act
Article 1 – point 10 a (new)
Article 1 – point 10 a (new)
Directive 2001/83/EC
Article 63 – paragraph 1
Article 63 – paragraph 1
Amendment 330 #
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)
Amendment 355 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 1 – point b
Article 111b – paragraph 1 – point b
(b) the regularity of repeated and unannounced inspections of good manufacturing practices;