Activities of Antonyia PARVANOVA related to 2008/0260(COD)
Shadow opinions (1)
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Amendments (20)
Amendment 23 #
Proposal for a directive – amending act
Citation 2 a (new)
Citation 2 a (new)
Having regard to the opinion of the European Data Protection Supervisor1, 1 OJ C 229, 23.9.2009, p. 19.
Amendment 24 #
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. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, identified by a corresponding explanatory sentence on the summary of product characteristics, and on the patient information leaflet, 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 Agency (hereinafter referred to as the ‘Agency’).
Amendment 33 #
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2001/83/EC
Article 11
Article 11
3. Article 11 is amended as follows: (a) the following point 3a is inserted: “(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, fsubparagraph is added: “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 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 36 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21 a – introductory part
Article 21 a – introductory part
Amendment 48 #
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
Article 59(1) is amended as follows: (a) the following point (aa) is inserted: “(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 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 intensiveand text “New information”. “(aa) ‘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 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 50 #
Proposal for a directive – amending act
Article 1 – point 20
Article 1 – point 20
Directive 2001/83/EC
Article 65 – point g and point g a (new)
Article 65 – point g and point g a (new)
In Article 65, the following points (g) isand (ga) are added: “(g) the summary of the essential information necessary to use the medicine safely and effectively provided for in Article 11(3a) and Article 59(1)(aa).” (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 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 70 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107k – paragraph 2 – subparagraph 1
Article 107k – 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, together with representatives from the Committee for Medicinal Products for Human Use. The Agency, in consultation with stakeholders, shall develop guidelines for the organisation and conduct of public hearings. The public hearing should also consider the effectiveness and benefits of the product as well as prior evaluations of benefit / risk carried out by the Committee for Medicinal Products or the coordination group under the procedure for granting marketing authorisation as described in paragraph 107l.
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 127 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21a - introduction
Article 21a - introduction
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 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 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 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 222 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 2 a (new)
Article 107 – paragraph 2 a (new)
2a. Unless justifiable on grounds related to pharmacovigilance, individual Member States shall not impose any additional reporting requirements on marketing authorisation holders.
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: