7 Amendments of Frédérique RIES related to 2008/0260(COD)
Amendment 54 #
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 biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with Article 25 of Regulation (EC) No 726/2004 and shall implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients;
Amendment 66 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 108 – paragraph 2 a (new)
Article 108 – paragraph 2 a (new)
Amendment 75 #
Proposal for a directive – amending act
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2001/83/EC
Article 1 – point 11
Article 1 – point 11
Amendment 190 #
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 biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with Article 25(1) of Regulation (EC) No 726/2004 and implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients;
Amendment 242 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 b
Article 107 b
1. Marketing authorisation holders shall be required to submit to the Agency periodic safety update reports containing: (a) summaries of data relevant to the benefits and risks of the medicinal product; (b) a scientific evaluation of the risk- benefit balain the following cases: (a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 21a or Article 22; or (b) where a Community reference date and the corresponding frequencey of the medicinal product; The evaluation referred to in point (b) shall be based on all available data, including data from clinical trials in unauthorised isubmission of periodic safety update reports have been determined in accordance with paragraphs 3 and 4 of Article 107c, subject to the condications and populations. The plaid down in Article 107c(5). 2. Periodic safety update reports shall be submitted electronically. 2. The Agency shall distribute the reports referred to in paragraph 1 to the Pharmacovigilance Risk Assessment Committee, the Committee for Mcontain: (a) a scientific evaluation of the risk- benefit balance of the medicinal product; (b) all data relating to the volume of sales of the medicinal Pproducts for Human Use and the coordination group. 3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products ref and any data in possession of the marketing authorisation holder red to in Articles 10, 10a or 10c, and holderslating to the volume of pregistrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases: (a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 21a or Article 22; or (b) where a Community reference date and the corresponding frequency of submission ofscriptions. The evaluation referred to in point (b) shall be based on all available data, including data from clinical trials in unauthorised indications and populations. The periodic safety update reports shavell been determined in accordance with paragraphs 3 and 4 of Article 107c, subject to the conditions laid down in Article 107c(5) submitted electronically.
Amendment 260 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 108 – point 5
Article 108 – point 5
(5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders, including the presentation of the collected information. The collected information must be presented, with the purpose of an appropriate evaluation and follow-up, in a way that makes it possible to distinguish the different adverse reactions, including overdose, misuse, abuse, medication errors, and those occurring in the course of studies with the medicinal product or after occupational exposure;
Amendment 262 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 108 – paragraph 2
Article 108 – paragraph 2
Those guidelines shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress. For the purposes of this Article and Article 102(3), the Commission, in cooperation with the Agency, Member States, and stakeholders, shall prepare detailed guidelines on good record- keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records that would be needed in the event of needing to file a pharmacovigilance report or to provide information needed by a marketing authorisation holder conducting an evaluation of an adverse event and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.