8 Amendments of Horst SCHNELLHARDT related to 2008/0260(COD)
Amendment 44 #
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 benefitsdescribing the benefits and possible adverse effects of the medicinal product and information aimed at ensuring its safe and effective use.
Amendment 77 #
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
Amendment 82 #
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 reaction: An adverse reaction in respect ofunintended event in which a causal relationship between the event and the medicinal product cannot be excluded.”;
Amendment 149 #
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 summary of the essential information necessary to use the medicinebrief description of the main characteristics of the medicinal product enabling the patient to understand its benefits and possible adverse effects and to use it safely and effectively;”
Amendment 220 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraphs 1 and 2
Article 107 – paragraphs 1 and 2
1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study. Marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the Community. By way of derogation to the first subparagraph, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC. 2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically from patients and health-care professionals.
Amendment 234 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 2
Article 107 a – paragraph 1 – subparagraph 2
Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals.
Amendment 236 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 3
Article 107 a – paragraph 3
3. The Member States shall ensure that reports of medication errors, or of adverse reactions derived from uses outside the authorised summary of the product characteristics, 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 263 #
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 concludedcannot be shown that therapeutic results cannot be obtained from the medicinal product.