18 Amendments of Peter LIESE related to 2008/0260(COD)
Amendment 31 #
Proposal for a directive – amending act
Recital 5 a (new)
Recital 5 a (new)
(5a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and an emerging public health concern. Actions to reduce the potentially harmful impacts on the European environment especially on surface water, groundwater and drinking water and public health are needed. Therefore, measures should also be taken to monitor the adverse environmental effects of medicinal products on public health or the environment. This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.
Amendment 32 #
Proposal for a directive – amending act
Recital 5 a (new)
Recital 5 a (new)
(5a) Research must be promoted to develop more targeted drugs to avoid side effects for patients and address environmental effects.
Amendment 48 #
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 76 #
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 reaction: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in the human body for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
Amendment 78 #
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 79 #
Proposal for a directive – amending act
Article 1 – point 1 – point a a (new)
Article 1 – point 1 – point a a (new)
Directive 2001/83/EC
Article 1 – point 11 a (new)
Article 1 – point 11 a (new)
(aa) The following point is inserted: “11a. Medication error: A response that is not an adverse reaction but that is due to errors and uses of a medicinal product outside the authorised summary of product characteristics, including the misuse and abuse of the product.”
Amendment 81 #
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 85 #
Proposal for a directive – amending act
Article 1 – point 1 – point b a (new)
Article 1 – point 1 – point b a (new)
Directive 2001/83/EC
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
(ba) The following point is inserted: “(14a) Adverse environmental effect: This includes noxious effect on public health or the environment, especially in surface water, groundwater and drinking water related to the environmental appearance of pharmaceuticals or their degradation products, or mixtures of pharmaceuticals and their degradation products.”
Amendment 90 #
Proposal for a directive – amending act
Article 1 – point 1 – point (c a) (new)
Article 1 – point 1 – point (c a) (new)
Directive 2001/83/EC
Article 1 – point 28 a (new)
Article 1 – point 28 a (new)
(ca) point 28a is replaced by the following: “(28a) Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks defined in point 28 […].”
Amendment 102 #
Proposal for a directive – amending act
Article 1 – point 2 – point -a (new)
Article 1 – point 2 – point -a (new)
Directive 2001/83/EC
Article 8 – paragraph 3 – point (i)
Article 8 – paragraph 3 – point (i)
(-a) a new indent ) is inserted after the second indent in point (i): “– ecotoxicological tests,”
Amendment 150 #
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 155 #
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 2
Article 59 – paragraph 1 – subparagraph 2
“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. form that is clearly legible, prominent and clearly distinguishable from the rest of the text. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”.
Amendment 167 #
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
Article 86 – paragraph 2
20a. The first indent of Article 86(2) is amended as follows: “– the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, and the summary of the product characteristics, insofar as they are made available to the public independently of the delivery of the medicinal product in unchanged wording and without additional promotional elements,”
Amendment 169 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 101 – paragraph 3
Article 101 – paragraph 3
3. Each Member State shall designate aone or more competent authorityies for the conduct of pharmacovigilance tasks.
Amendment 216 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3
Article 106 – point 3
(3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals, if applicable, and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004.
Amendment 231 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 1
Article 107a – paragraph 1 – subparagraph 1
The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients. . Concerning suspected adverse reactions reported by patients, Member States may decide whether those are reported directly or via health care professionals.
Amendment 247 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107b – paragraph 3 – introduction
Article 107b – paragraph 3 – introduction
3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of marketing authorisations for products containing active substances fulfilling the criteria of the concept of well-established medicinal use mentioned in Annex I, Part II, Point 1 (a) of this Directive, and holders of registrations for medicinal products referred to in Articles 146 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases:
Amendment 264 #
Proposal for a directive – amending act
Article 1 – point 24 a (new)
Article 1 – point 24 a (new)
Directive 2001/83/EC
Article 119 a (new)
Article 119 a (new)