14 Amendments of Michèle RIVASI related to 2008/0257(COD)
Amendment 16 #
Proposal for a regulation – amending act
Recital 4
Recital 4
(4) The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Community pharmacovigilance database and data-processing network (hereinafter referred to as 'the Eudravigilance database') and, the coordination of safety announcements by the Member States and the provision of information regarding safety issues to the public.
Amendment 27 #
Proposal for a regulation – amending act
Recital 11
Recital 11
(11) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the Agency. Provision should be made to allow adequate funding for pharmacovigilance activities through the collection of fees charged to marketing authorisation holders. The management of those collected funds should be under a permanent control of the Management Board in order to guarantee the independence ofing to pharmacovigilance by the Agency.
Amendment 33 #
Proposal for a regulation – amending act
Recital 20 a (new)
Recital 20 a (new)
(20a) This Regulation shall apply without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data1 and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data2. In order to detect, assess, understand and prevent adverse reactions, and to identify and take action to reduce risks and increase benefits from medicinal products for the purpose of safeguarding public health, it should be possible to process personal data within the Eudravigilance system while complying with EU data protection legislation. 1 OJ L 281, 23.11.1995, p. 31. 2 OJ L 8, 12.1.2001, p. 1.
Amendment 36 #
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation EC/726/2004
Article 5 – paragraph 2
Article 5 – paragraph 2
"For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa)."
Amendment 40 #
Proposal for a regulation – amending act
Article 1 – point 5 c
Article 1 – point 5 c
Regulation EC/726/2004
Article 14 – paragraph 8
Article 14 – paragraph 8
"8. In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to meet certain conditionintroduce specific procedures, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC. Continuation of the authorisation shall be linked to the annual reassessment of these conditions."
Amendment 47 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based and other structured forms for the reporting of suspected adverse reactions by health-care professionals and patients.
Amendment 51 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – point 2
Article 26 – point 2
(2) a summary of each meetinggendas for meetings and records of meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the coordination group as regards pharmacovigilance activities;
Amendment 61 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28 – paragraph 3
Article 28 – paragraph 3
3. The Pharmacovigilance Risk Assessment Advisory Committee shall assessCommittee shall assess scientifically the risk-benefit balance of the medicinal product on the basis of all the information available, including the periodic safety update reports. It shall prepare an assessment repor and the data entered in the Eudravigilance database. It shall prepare a scientific report on the risk-benefit balance of the medicinal product within 90 days of receipt of the periodic safety update report and send it to the marketing authorisation holder and the coordination group. Within 30 days of receipt of the assessment report, the marketing authorisation holder may submit comments to the Agencyand the coordination group may submit comments to the Pharmacovigilance Committee. At its next meeting following the end of the period for comments by the marketing authorisation holder, the Pharmacovigilance Risk Assessment Advisory and the coordination group, the Pharmacovigilance Committee shall adopt the assessment report with or without changes, taking into account any comments submitted by the marketing authorisation holder. With effect from [insert date 18 months after the date referred to in Article 3] assessment reports shall be published immediately on the European medicines safety web-portal.
Amendment 62 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28 – paragraph 4 – subparagraph 1
Article 28 – paragraph 4 – subparagraph 1
4. Within 30 days of receiptadoption of the report by, the Pharmacovigilance Risk Assessment Advisory Committee, the Committee for Medicinal Products for Human Use shall consider the report andCommittee shall adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Amendment 63 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28 – paragraph 6
Article 28 – paragraph 6
6. The evaluation reports, opinions and decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web- portal referred to in Article 26.
Amendment 65 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28d
Article 28d
Upon request of the Commission, the Agency shall participate, in collaboration with the Member States and all interested parties, in international harmonizsation and standardizsation of technical measures in pharmacovigilance. Such work shall be based on patient needs and be carried out from a scientific perspective.
Amendment 69 #
Proposal for a regulation – amending act
Article 1 – point 12 – point a
Article 1 – point 12 – point a
Regulation EC/726/2004
Article 56 – paragraph 1 – point aa
Article 56 – paragraph 1 – point aa
"(aa) the Pharmacovigilance Risk Assessment Advisory Committee, which shall be responsible for providing advice to the Committee for Mthe pharmacovigilance assessment of medicinal Pproducts for Human Use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human usplaced on the market in accordance with the centralised procedure;"
Amendment 78 #
Proposal for a regulation – amending act
Article 1 – point 15 – point b
Article 1 – point 15 – point b
Regulation EC/726/2004
Article 62 – paragraph 2 – subparagraph 1
Article 62 – paragraph 2 – subparagraph 1
"Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise, and also of their degree of independence from pharmaceutical firms."
Amendment 79 #
Proposal for a regulation – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Regulation EC/726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
"4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. Thisey shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agencyreceive adequate public funding commensurate with the tasks conferred."