Activities of Antonyia PARVANOVA related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Shadow opinions (1)
OPINION Proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
Amendments (19)
Amendment 27 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Member States should reinforce their cooperation in the fields of justice and police, including through Europol, to enforce existing restrictions on the illegal supply of medicinal products via the internet.
Amendment 29 #
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 (new)
Article 1 – point 2 a (new)
-1) In Article 1, the following point 2a is inserted after point 2: "2a." Falsified medicinal product Any product with a false representation (1) of its identity (2) and/or source (3). This definition covers the product itself, its container or other packaging or labelling information. A falsified medicinal product may be either branded or generic.. A falsified medicinal products may include products with the correct ingredients/components(4), with the wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with false packaging. Infringements or disputes concerning patents must be distinguished from counterfeiting or falsification of medicinal products. Medicinal products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere shall not be considered falsified. Sub-standard batches or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate medicinal products shall not be considered falsified. Notes: (1) Falsification of medicinal products is fraudulent and deliberate. Criminal intent and/or negligence shall be factors to be taken into account during the legal procedure for the purposes of imposing sanctions. (2) This includes any misleading statement with respect to the name, composition, strength, or other elements. (3) It also includes any misleading statement with respect to the manufacturer, country of manufacture, country of origin, marketing authorization holder or distribution chain. (4) It refers to all the components of a medicinal product."
Amendment 47 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 4 – subparagraph 5 a (new)
Article 54a – paragraph 4 – subparagraph 5 a (new)
The measures referred to in this paragraph shall take due account of at least all of the following: (a) The cost effectiveness of the system, in order to ensure that any measure that is applied is based on a cost benefit analysis. (b) The costs relating to the measures shall be shared proportionately by all the actors in the supply chain and be linked to the price of the medicinal product concerned. (c) The independence of the system and the legitimate interest in protecting information of a commercially confidential nature and the protection of industrial and commercial property rights and of personal data.
Amendment 51 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83(EC)
Article 118 b
Article 118 b
The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. Applicable penalties shall take into account the threat to public health represented by the falsification of medicinal products. The penalties provided for must be harmonised, effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by [insert concrete date 18 months after publication] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Amendment 83 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a). Over-the counter (OTC) medicinal products should be the subject of regular risk analysis study carried out by national authorities. Depending on the results of this risk analysis study, OTC medicinal products may be integrated into the scope of Directive 2001/83/EC. For that purpose, the marketing authorisation holders have the right, as soon as this Directive has entered into force, to submit their OTC medicinal products to the provisions included in this Directive.
Amendment 182 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 46 – point g
Article 46 – point g
(b) The following point (g) is added: ‘(g) to inform the competent authority of products he gets knowledge of which are or which are suspected to be falsified in relation to the identity, history or source of products manufactured by him either in the legal supply chain or being sold by means of illegal internet trade.’
Amendment 220 #
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
Amendment 224 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 2 – point a
Article 54a - paragraph 2 – point a
Amendment 227 #
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
Amendment 238 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 2 – point c
Article 54a - paragraph 2 – point c
Amendment 254 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – introductory part
Article 54a – paragraph 4 – subparagraph 3 – introductory part
When adopting those measures, the Commission shall consider the risk related to products or categories ofescription products and at least all of the following:
Amendment 256 #
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 a
Article 54a – paragraph 4 – subparagraph 3 – point a
Amendment 260 #
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 within the Communityand frequency of past incidences of reported cases of counterfeited medicines within the Union and the evolution of those incidences in the past;
Amendment 263 #
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 c
Article 54a – paragraph 4 – subparagraph 3 – point c
Amendment 265 #
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 d
Article 54a – paragraph 4 – subparagraph 3 – point d
Amendment 267 #
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
Article 54a – paragraph 4 – subparagraph 3 – point e
Amendment 272 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 4
Article 54a – paragraph 4 – subparagraph 4
On the basis of these criteria, the requirementmeasures referred to in points (ao) and (b) ofof Article 54 and the requirements referred to in paragraph (1) and (2) of this Article may be waived for certain products or product categoriesshall be applied compulsorily only to those products or product categories found to pose a high risk of falsification, and be waived or voluntary for those products or product categories that do not pose a high risk of falsification such as, generic medicinal products authorised in accordance with Article 10.
Amendment 279 #
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 ofat least all of the following: (a) the cost-effectiveness of the system, in order to guarantee that any measure that is applied is based on a cost-benefit analysis; (b) the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned; (c) the independence of the system and the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights and personal data.
Amendment 363 #
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)