11 Amendments of Corinne LEPAGE related to 2008/0260(COD)
Amendment 103 #
Proposal for a directive – amending act
Article 1 – point 2 – point a
Article 1 – point 2 – point a
Directive 2001/83/EC
Article 8 – paragraph 3 – point “ia” - introductory sentence
Article 8 – paragraph 3 – point “ia” - introductory sentence
(ia) A detailed description and summary of the applicant's pharmacovigilance system which shall include the following elements:
Amendment 123 #
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 132 #
Proposal for a directive – amending act
Article 1 – paragraph 8
Article 1 – paragraph 8
Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2
Article 21a – point 4 – subparagraph 2
The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary and stipulate that continuation of the authorisation shall be linked to timely compliance with the conditions laid down.
Amendment 173 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority orand the marketing authorisation holder;
Amendment 199 #
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 regularn annual 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, communicate them to the competent national authority before 31 December each year. Based on the audit findings, the marketing authorisation holder shall ensure that an appropriate corrective action plan is prepared and followed.
Amendment 200 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 104 – paragraph 3 – point d a (new)
Article 104 – paragraph 3 – point d a (new)
(da) submit to the competent national authority a detailed description of the risk management system that he intends to establish;
Amendment 201 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 104 – paragraph 3 – point d b (new)
Article 104 – paragraph 3 – point d b (new)
(db) incorporate the requirements of the competent national authority following this assessment;
Amendment 202 #
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 justification, and include the timeframe for submission of the detailed description of the risk- management system. It shall be made public without delay.
Amendment 205 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105
Article 105
Activities connected with pharmacovigilance, the operation of communication networks and market surveillance should be financed primarily through either national or EU public funding. The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the national competent authorities in order to guarantee their independence. The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of those activities by the national competent authoritiesby the Agency of further resources for carrying out those activities as fees to be paid by marketing authorisation holders, provided that its independence is strictly guaranteed.
Amendment 250 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107g – paragraph 1
Article 107g – paragraph 1
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. The opinion shall be published immediately, indicating any minority views.
Amendment 251 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107g – point 3
Article 107g – point 3
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 opinion shall be published immediately, indicating any minority views.