21 Amendments of Pilar AYUSO related to 2008/0260(COD)
Amendment 27 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) For the sake of clarity, the definition of adverse reaction“medication error” should be amendintroduced, to ensure that it not only covers noxious and unintended effectspreventable non-intentional and inappropriate incidents, resulting in an adverse reaction, derived from the authorised use of a medicinal product at the normal doses, but also medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the productare covered by this Directive.
Amendment 34 #
Proposal for a directive – amending act
Recital 6
Recital 6
(6) The marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products, recorded in a Pharmacovigilance System Master File permanently accessible for inspection. The competent authorities should undertake the supervision of those systems. A summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the Pharmacovigilance System Master File for the medicinal product concerned is maintained and accessible for inspection by the competent authorities.
Amendment 52 #
Proposal for a directive – amending act
Recital 10 a (new)
Recital 10 a (new)
(10a) Within 24 months of the publication of this directive in the Official Journal of the European Union, the Commission shall present to the European Parliament and the Council an assessment report regarding the relevance of the summaries of product characteristics and the package leaflets to the needs of patients and healthcare professionals. On the basis of this, the Commission shall issue, as required, legal recommendations and/or proposals in order to improve these two documents.
Amendment 60 #
Proposal for a directive – amending act
Recital 18
Recital 18
(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders and the Member States should report those reactions only to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’). The Eudravigilance database should simultaneously and electronically notify the relevant Member States of reports submitted by market authorisation holders.
Amendment 67 #
Proposal for a directive – amending act
Recital 22
Recital 22
(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products. Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should not be necessarybe required for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products. However, in the interest of public health the authorities should require periodic safety update reports for such products when there is a need to assess their risk or review the adequacy of product information.
Amendment 84 #
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 of which a causal relationship between the event and the mediciMedication error: Any preventable non-intentional and inappropriate event or incident that led, or could have led, to an adverse effect, while the medication was under the control of a healthcare professional, product cannot be excluded.atient or consumer. Medication errors leading to adverse effects should, for reporting purposes, be considered adverse reactions”
Amendment 107 #
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a and Article 11 – paragraph 3
Article 11 – paragraph 1 – point 3a and Article 11 – paragraph 3
“(3a) a summary of the essential information necessary to use the medicine safely and effectively;” (b) The following subparagraph is added: “For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product iWithin 24 months of the publication of this directive in the Official Journal of the European Union, the Commission shall present to the European Parliament and the Council an assessment report regarding the relevance of the summaries of product characteristics and the package leaflets to the needs of patients uander intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority> healthcare professionals. On the basis of this, the Commission shall issue, as required, legal recommendations and/or proposals in order to improve these two documents.”
Amendment 122 #
Proposal for a directive – amending act
Article 1 – point 7
Article 1 – point 7
Directive 2001/83/EC
Article 21 – paragraph 4 – subparagraph 2
Article 21 – paragraph 4 – subparagraph 2
The national competent authorities shall make publicly accessible without delay the final assessment report, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each indication applied for.
Amendment 135 #
Proposal for a directive – amending act
Article 1 – point 10
Article 1 – point 10
Directive 2001/83/EC
Article 22a – paragraph 1
Article 22a – paragraph 1
1. After the granting of a marketing authorisation, the national competent authority may require a marketing authorisation holder to conduct a post- authorisation safety study if there are concerns about the risks of an authorised medicinal product. The requirement shall be made in writing, provide a detailed scientific justification and include the objectives and timeframe for submission and conduct of the study.
Amendment 137 #
Proposal for a directive – amending act
Article 1 – point 12 – point b
Article 1 – point 12 – point b
Directive 2001/83/EC
Article 24– paragraph 3
Article 24– paragraph 3
3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds relating to pharmacovigilance or to insufficient exposure to the product, to proceed with one additional five-year renewal in accordance with paragraph 2.”
Amendment 151 #
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
Amendment 159 #
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 – subparagraphs 2 and 3
Article 59 – paragraph 1 – subparagraphs 2 and 3
(b) the following second and third subparagraphs are is added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. 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”. For medicinal products includeWithin 24 months from the publication of this Directive in the Official Journal of the European Union, the Commission shall undertake to submit a report to the European Parliament and the Council on the relevance of the summary of product characteristics and onf the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensive monitoring. All suspected advpackage leaflet in relation to the needs of patients and health care professionals. On this basis, the Commission shall, wherse reactions should be reported to <name and web-address of the national competent authority>“necessary, make recommendations and/or legislative proposals to improve these two documents.”
Amendment 166 #
Proposal for a directive – amending act
Article 1 – point 20 a (new)
Article 1 – point 20 a (new)
Directive 2001/83/EC
Article 65 – point g a (new)
Article 65 – point g a (new)
20a. In Article 65, the following point is added: “(ga) the Community procedure defining a procedural timeline, a clear structure and defined roles for all the stakeholders involved, including for the conduct of public hearings.”
Amendment 189 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 3
Article 102 – paragraph 1 – point 3
(3) through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biologicalensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a report on a suspected adverse reaction is identifiable by, as far as available, the name of the MAH, the INN, the name of the medicinal product prescriand the batch numbedr, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable;using the standard forms and procedures developed in accordance with Article 25(1) of the Regulation (EC) No 726/2004 and taking due account of the developments within the EudraVigilance system. For the purposes of point (1) and (3) of the first paragraph the Member States may impose specific requirements on doctors, pharmacists and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions.
Amendment 203 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 104a – paragraph 2 – subparagraph 2
Article 104a – paragraph 2 – subparagraph 2
The requirement shall be made in writing, provide a detailed scientific justification, and include the timeframe for submission of the detailed description of the risk- management system.
Amendment 249 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 g – paragraphs 1, 2 and 3
Article 107 g – paragraphs 1, 2 and 3
1. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which does not include any marketing authorisation granted in accordance with Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion. Before adopting such a decision, the coordination group must enable the marketing authorisation holders concerned to submit written or verbal explanations within the required time- limits, which must be specified. 2. If the opinion of the coordination group is adopted by consensus, the chairman shall record the agreement and inform the marketing authorisation holder accordingly. The Member States shall maintain, vary, suspend or revoke the marketing authorisations concerned as necessary to comply with the opinion within the determined time table for implementation, and they shall inform the Commission and the coordination group. If an opinion by consensus cannot be adopted, the majority opinion shall be forwarded to the Commission which shall apply the procedure laid down in Articles 33 and 34. However, by way of derogation from Article 34(1), the procedure referred to in Article 121(2) shall apply. The stages of the procedure described in Article 32(4) of Directive 2004/83/EC may apply. 3. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned. The stages of the procedure described in Article 9(2) of Regulation (EC) No 726/2004 may apply.
Amendment 252 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 i
Article 107 i
1. A Member State shall initiate the procedure under this section, by informing the other Member States, the Agency and the Commission, the Commission and the marketing authorisation holders potentially affected, in any of the following cases: (a) it considers, in the light of the outcome of the assessment of pharmacovigilance data, one of the following regulatory measures: – suspending or revoking of a marketing authorisation; (b) it considers– prohibiting the supply of a medicinal product; (c) it considers– refusing the renewal of a marketing authorisation; (db) it is informed by the marketing authorisation holder that, on the basis of safety concerns, he has interrupted the placing on the market of a medicinal product or withdrawn a marketing authorisation, or that he intends to do so; (e) it considers that new contraindications, a reduction in the recommended dose, or a restriction to the indications is necessary; (fc) it has conducted a pharmacovigilance inspection and found serious deficiencies.
Amendment 254 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 k – paragraph 2 – subparagraph 1
Article 107 k – paragraph 2 – subparagraph 1
2. The Pharmacovigilance Risk Assessment Advisory Committee shall assess the matter which has been submitted. For the purposes of that assessment, it may hold a public hearing, if objective criteria are met on the basis of scientific data, taking account of the effectiveness and benefits of the product concerned and of earlier risk/benefit assessments conducted by the Committee for Medicinal Products for Human Use or the coordination group in accordance with the procedure for granting marketing authorisations described in Article 107l, which must involve the rapporteur of the Committee for Medicinal Products for Human Use on the product in question, or the rapporteur of the coordination group. The Agency, in consultation with the parties concerned, shall draw up guidelines on the organisation and conduct of public hearings.
Amendment 255 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 k – paragraph 3 – introduction
Article 107 k – paragraph 3 – introduction
3. Within 60 days of the information submitted, the Pharmacovigilance Risk Assessment Advisory Committee shall make a recommendation, stating the reasons on which it is based, and also taking account of the benefits of the medicinal product as assessed by the Committee for Medicinal Products for Human Use or the coordination group in accordance with the procedure for granting marketing authorisations described in Article 107l. The recommendation shall be any or a combination of the following:
Amendment 256 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107m
Article 107m
The Agency shall make public the final conclusions (recommendations, opinions and final decisions) referred to in Articles 107b to 107l by means of the European medicines safety web-portal.
Amendment 268 #
Proposal for a directive – amending act
Article 1 – point 28
Article 1 – point 28
Directive 2001/83/EC
Article 2 – paragraph 1
Article 2 – paragraph 1