6 Amendments of Cristina GUTIÉRREZ-CORTINES related to 2008/0257(COD)
Amendment 18 #
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) Where a medicinal product is authorizsed subject to the requirement to conduct a post-authorisation safety study or subject to 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, and a publicly available list of such medicinal products should be kept up to date by the Agency. Patient reports should always be drawn up with the aid of a healthcare professional.
Amendment 19 #
Proposal for a regulation – amending act
Article 1 – point 4
Article 1 – point 4
Regulation (EC) No 726/2004
Article 10 a – paragraph 3
Article 10 a – paragraph 3
3. On the basis of explanations submitted by the marketing authorisation holder, the Commission shall withdraw or confirm the requirement. Where the Commission confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly. Irrespective of whether the requirement is confirmed or withdrawn, the Commission must state the grounds for its decision in detail, and the decision shall be duly recorded.”
Amendment 27 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a. Given that certain medicinal products cause adverse reactions, the Agency or the competent authorities should allow for the obligation of confirming the diagnosis before starting any treatment using those products.
Amendment 30 #
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or subject to 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, and a publicly available list of such medicinal products should be kept up to date by the Agency. Patient reports should always be drawn up with the aid of a healthcare professional.
Amendment 38 #
Proposal for a regulation – amending act
Article 1 – point 4
Article 1 – point 4
Regulation EC/726/2004
Article 10a – paragraph 3
Article 10a – paragraph 3
3. On the basis of explanations submitted by the marketing authorisation holder, the Commission shall withdraw or confirm the requirement. Where the Commission confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly. Irrespective of whether the requirement is confirmed or withdrawn, the Commission must state the grounds for its decision in detail, and the decision shall be duly recorded.
Amendment 59 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a. Given that certain medicinal products cause adverse reactions, the Agency or the competent authorities should allow for the obligation of confirming the diagnosis before starting any treatment using those products.