24 Amendments of Thomas ULMER related to 2008/0260(COD)
Amendment 28 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived not only from the authorised use of a medicinal product at the normal doses, but also from medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
Amendment 41 #
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. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. 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 Agency12 (hereinafter referred to as the ‘Agency’).
Amendment 43 #
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 medicines they use, the summary of the product characteristics and the package leaflet should include, for all medicinal products except those referred to in Articles 10, 10a and 10c, 14, 16 and 16a of Directive 2001/83/EC, a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.
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 64 #
Proposal for a directive – amending act
Recitals 20 a (new)
Recitals 20 a (new)
(20a) Reporting through health professionals should be especially encouraged in cases where their input could be essential to understand the significance of the adverse reaction, and in such cases adverse reaction linked to medication errors. In order to facilitate this reporting, health professionals’ access to medication data contained in the patient health record should be facilitated.
Amendment 73 #
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 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 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 83 #
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 105 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a
Article 11 – paragraph 1 – point 3a
“(3a) for all medicinal products, except for those referred to in Articles 10, 10a and 10c, 14, 16 and 16a, a summary of the essential information necessary to use the medicine safely and effectively.”
Amendment 148 #
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 medicine safely and effectively; except for the medicinal products referred to in Articles 10, 10a and 10c, 14, 16 and 16a.”
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 197 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 104 – paragraph 2 – subparagraph 2
Article 104 – paragraph 2 – subparagraph 2
The marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system. He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and followed.
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 223 #
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 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 235 #
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 arcan be submitted by means of the national medicines safety web- portals.
Amendment 238 #
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 246 #
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 16, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases:
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 248 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107c – paragraph 2 – subparagraph 1
Article 107c – paragraph 2 – subparagraph 1
2. Holders of marketing authorisations which were granted before [insert concrete date - date set out in the second subparagraph of Article 3(1)], and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation, shall submit the periodic safety update reports in accordance with the second subparagraph of this paragraph until another frequency or other dates of submission of the reports are laid down in the marketing authorisation or determined in accordance with paragraphs 3, 4, 5 or 6. This obligation does not cover products referred to in Art. 107b(3) unless the conditions set out in points (a) and (b) of Article 107b(3) apply.