BETA

Activities of Dagmar ROTH-BEHRENDT related to 2008/0261(COD)

Plenary speeches (1)

Falsified medicinal products (debate)
2016/11/22
Dossiers: 2008/0261(COD)

Amendments (8)

Amendment 74 #
Proposal for a directive – amending act
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.
2010/03/12
Committee: ENVI
Amendment 178 #
Proposal for a directive – amending act
Article 1 – point 3 – point a a (new)
Directive 2001/83/EC
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.
2010/03/12
Committee: ENVI
Amendment 191 #
Proposal for a directive – amending act
Article 1 – point 4
Directive 2001/83/EC
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.
2010/03/12
Committee: ENVI
Amendment 231 #
Proposal for a directive – amending act
Article 1 - point 9
Directive 2001/83/EC
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;
2010/03/12
Committee: ENVI
Amendment 276 #
Proposal for a directive – amending act
Article 1 - point 9
Directive 2001/83/EC
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.
2010/03/12
Committee: ENVI
Amendment 296 #
Proposal for a directive – amending act
Article 1 – point 10 a (new)
Directive 2001/83/EC
Article 63 – paragraph 1
In Article 63, paragraph 1 is replaced by the following: 1. The particulars for labelling listed in Articles 54, 55, 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market. The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used. In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Community.
2010/03/12
Committee: ENVI
Amendment 330 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Directive 2001/83/EC
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. Internet pharmacies shall, in Member States in which they are allowed to operate, require a special authorisation by the competent authority. 2. 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 an authorised pharmacy. The logo shall be linked to a 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. 3. Member States shall take the appropriate measures to ensure that all authorised pharmacy internet sites linked to pharmacies within their territory display the Community logo referred to in paragraph 1 and to prevent non- authorised pharmacy internet sites from using the logo and linking to the central website referred to in paragraph 1. 4. To implement paragraphs 2 and 3 the Commission shall, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, adopt a Directive, laying down: - the minimum requirements preventing the entry of falsified medicines into the supply chain to be applied by the Member States if they authorise such internet pharmacies. Such requirements shall also prevent the reimbursement of medicinal products from unauthorised internet sources, - the model of the Community logo, - the type of minimum background information on the risks related to buying medicinal products on the internet and - specific control procedures for the authorisation of internet pharmacies.'
2010/03/12
Committee: ENVI
Amendment 355 #
Proposal for a directive – amending act
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 1 – point b
(b) the regularity of repeated and unannounced inspections of good manufacturing practices;
2010/03/12
Committee: ENVI