Activities of António Fernando CORREIA DE CAMPOS 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 (9)
Amendment 34 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) In order to ensure the collection of any necessary additional data about the safety of authorised medicinal products, competent authorities should be empowered to require post-authorisation safety studies at the time of the granting of the marketing authorisation or later, and this requirement should be included as a condition of the marketing authorisation. If the conditions included in the marketing authorisation are not met within the deadline set, the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.
Amendment 41 #
Proposal for a directive – amending act
Article 1 – point 1 – point d
Article 1 – point 1 – point d
Directive 2001/83/EC
Article 1 – point 28b
Article 1 – point 28b
(28b) Risk management system: a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks already detected, and risks identified subsequently, relating to a medicinal product, including the assessment of the effectiveness of those interventions.
Amendment 42 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 - subparagraph 3
Article 11 - subparagraph 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 statements: “This(a) "This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name and, web-address, postal address and telephone number of the national competent authority>, or reported directly to the pharmacy"; (b) An exclamation mark surrounded by a red triangle. This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product.
Amendment 48 #
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 3
Article 59 – paragraph 1 – subparagraph 3
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statements shall be included: (a) “This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name and, web-address of the national competent authority>, postal address and telephone number of the national competent authority>,or reported directly to the pharmacy"; (b) An exclamation mark surrounded by a red triangle. This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product.
Amendment 52 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)
Article 102 – paragraph 1 – point 1 a (new)
(1a) conduct public awareness campaigns on the importance of reporting adverse reactions and possible ways of doing so;
Amendment 55 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)
Article 102 – paragraph 1 – point 3 a (new)
(3a) take the necessary steps to enable the public to report adverse reactions, in particular by ensuring that appropriate forms are available at pharmacies, drawn up in line with technical criteria and complying with the principles of simplified language and structure, accessible to the general public; these forms shall be sent by the pharmacists to the competent authorities;
Amendment 56 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 103 – paragraph 2 a (new)
Article 103 – paragraph 2 a (new)
The Member States shall cooperate with each other in order to develop the appropriate skills and capacities to supervise the pharmacovigilance system on their territory.
Amendment 57 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105 – paragraph 2
Article 105 – paragraph 2
The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders foras a contribution to the carrying out of those activities by the national competent authorities.
Amendment 58 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 a (new)
Article 106 – point 3 a (new)
(3a) A summary of the periodic safety update reports showing the assessment made by the competent authorities, including the analysis of the risk-benefit balance of the medicinal product.