10 Amendments of Jorgo CHATZIMARKAKIS related to 2008/0260(COD)
Amendment 35 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Steps must be taken to ensure that tightening up the pharmacovigilance system does not result in marketing authorisations being issued prematurely. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 37 #
Proposal for a directive – amending act
Recital 10
Recital 10
(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefitsutlining the benefits and potentially noxious effects of the medicinal product and giving further indications with a view to its safe and effective use.
Amendment 39 #
Proposal for a directive – amending act
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2001/83/EC
Article 1 – point 11
Article 1 – point 11
(11) Adverse drug reaction: A response to a medicinal product which is noxious and unintended.
Amendment 40 #
Proposal for a directive – amending act
Article 1 – point 1 – point b
Article 1 – point 1 – point b
Directive 2001/83/EC
Article 1 – point 14
Article 1 – point 14
(14) Suspected adverse drug reaction: An adverse reactionunintended event in respect of which a causal relationship between the event and the medicinal product cannot be excluded.
Amendment 45 #
Proposal for a directive – amending act
Article 1 – point 18 – point a
Article 1 – point 18 – point a
Directive 2001/83/EC
Article 59 – paragraph 1 – point aa
Article 59 – paragraph 1 – point aa
(aa) a summarybrief description of the essential information necessary to use the medicinefeatures of the medicine enabling the patient to understand its benefits and potentially noxious effects and to use it safely and effectively.
Amendment 49 #
Proposal for a directive – amending act
Article 1 – point 20 a (new)
Article 1 – point 20 a (new)
Directive 2001/83/EC
Article 86 - paragraph 2 – indent 1
Article 86 - paragraph 2 – indent 1
20a. The first indent of Article 86(2) is replaced by the following: ‘- the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, and the summary of the medicinal product’s features, even if they are made available to the public independently of the medicinal product, in unchanged form and with no additional promotional material,’
Amendment 59 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 2
Article 107a – paragraph 1 – subparagraph 2
Member States shall ensure that reports of such reactions armay be submitted by means of the national medicines safety web- portals.
Amendment 60 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 3
Article 107a – paragraph 3
3. The Member States shall ensure that reports of medication errors, or of the unintended effects of medicinal products used contrary to the indications covered by the authorisation, brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and to any authorities responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.
Amendment 61 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 3 a (new)
Article 107a – paragraph 3 a (new)
3a. The Member States shall ensure that marketing authorisation holders may electronically transmit information on unintended effects of medicinal products to national databases so that country- specific safety problems can be identified more effectively and more promptly.
Amendment 67 #
Proposal for a directive – amending act
Article 1 – point 23
Article 1 – point 23
Directive 2001/83/EC
Article 116 – paragraph 1
Article 116 – paragraph 1
The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken that the product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it is concludhas not been demonstrated that therapeutic results cannot be obtained from the medicinal product.