Activities of Jens ROHDE 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 (4)
Amendment 47 #
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 – subparagraph 2 and 3
Article 59 – paragraph 1 – subparagraph 2 and 3
Amendment 53 #
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 suspected adverse reaction report is identifiable by, as far as available, the name of the marketing authorisation holder, the International Non-proprietary Name (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 identifiableusing the standard forms and procedures developed in accordance with Article 25 of Regulation (EC) No 726/2004 and taking due account of the developments within the EudraVigilance system;
Amendment 64 #
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 or the coordination group, depending on the procedure for granting the marketing authorisation of the medicinal product as described in Article 107l. The Agency, in consultation with stakeholders, shall develop guidelines for the organisation and conduct of public hearings. The hearing shall ensure a fair balance between the assessment of risks and benefits of the product and shall in this regard also take into account previous risk-benefit assessments by the Committee for Medicinal Products for Human use or the coordination group, depending on the procedure for granting the marketing authorisation of the medicinal product as described in Article 107l.
Amendment 65 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107k – paragraph 3 - subparagraph 1 - introductory part
Article 107k – paragraph 3 - subparagraph 1 - introductory part
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. The recommendation, which shall not pre-empt the assessment of the risk-benefit balance by the Committee for Medicinal Products for Human use or the Coordination group before those bodies adopt their opinion in accordance with Article 107l, shall be any or a combination of the following: