6 Amendments of Ashley FOX related to 2008/0260(COD)
Amendment 35 #
Proposal for a directive – amending act
Article 1 – point 7
Article 1 – point 7
Directive 2001/83/EC
Article 21 – paragraph 3
Article 21 – paragraph 3
“3. The national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet, the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised.
Amendment 56 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 1
Article 106 – point 1
Each Member State shall set up and maintain a national medicines safety web- portal which shall be linked to the European medicines safety web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines safety web-portals, the Member States shall make public at least the following: (1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;
Amendment 58 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 2
Article 106 – point 2
(2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements;
Amendment 59 #
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) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products;
Amendment 60 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 b (new)
Article 106 – point 3 b (new)
(3b) a brief document history of changes made to the product information. All information on the safety web-portals, including that set out in points 1 to 3a of this Article, shall be presented in an understandable way for the general public. Information on safety and potential risks of a medicinal product shall be provided in the context of the overall proven benefits.
Amendment 62 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 a – paragraph 4
Article 106 a – paragraph 4
4. When the Agency or national competent authorities make information referred to in paragraphs 2 and 3 public, any information of a personal or commercially confidential nature shall be deleted in consultation with the marketing authorisation holder unless its public disclosure is necessary for the protection of public health.