16 Amendments of Françoise GROSSETÊTE related to 2008/0260(COD)
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 49 #
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 mosthave access to relevant information about the medicines they use, there should also be available, in addition to the summary of the product characteristics and the package leaflet should include, a reference to the existence of a website or a toll-free telephone line provided by the competent authorities and/or the marketing authorisation holder, including, for each product, a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.
Amendment 58 #
Proposal for a directive – amending act
Recital 18
Recital 18
(18) In order to simplify the reporting of suspected adverse reactions and to enable Member States to access the same information simultaneously, 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’). From this perspective, and in order to achieve the objectives referred to above, Member States should not impose any further requirements on marketing authorisation holders in respect of the prompt and regular reporting of suspected adverse reactions.
Amendment 108 #
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
Amendment 110 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 – paragraph 3
Article 11 – paragraph 3
“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 following statement: “This medicinal product is under intensivesubject to a post- authorisation safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web -address of the national competent authority>.”
Amendment 116 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 – paragraph 3
Article 11 – paragraph 3
“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 is under intensivethorough post- authorisation monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority> or to your doctor, pharmacist or another healthcare professional.”
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 152 #
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 usereference to the existence of a free- phone number provided by the competent authorities and/or the marketing authorisation holder or a website which, for each medicinal product, includes a section with concise essential information about the medicine saf, as welyl and effectively; s advice on how to maximise its benefits whilst minimising any risks associated with its use;
Amendment 153 #
Proposal for a directive – amending act
Article 1 – point 18
Article 1 – point 18
Directive 2001/83/EC
Article 59 – paragraph 1
Article 59 – paragraph 1
“(aa) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following second and third subparagraphs are 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 included on 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 intensivea summary including the following statement: ‘This medicinal product is subject to post- authorisation safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web-address of the national competent authority>”’.”
Amendment 154 #
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
(ba) the following second and third subparagraphs are 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 included on 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 intensivepoint (a b) is inserted: “(ab) For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, summary including the following statement: ‘This medicinal product is subject to post- authorisation detailed safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web-address of the national competent authority>”’.” (The third subpara of the Commission text largely corresponds to the second subpara of theOr. en amendment)
Amendment 183 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)
Article 102 – paragraph 1 – point 3 a (new)
Reporting of suspected adverse reactions resulting from medication errors should be done anonymously and with due regard for medical confidentiality.
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 198 #
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 thatconcerning any modifications made following the audit in accordance with an appropriate corrective action plan is prepared and followed.
Amendment 213 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 1
Article 106 – point 1
(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;
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.