Activities of António Fernando CORREIA DE CAMPOS related to 2008/0257(COD)
Plenary speeches (1)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Amendments (1)
Amendment 25 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structured forms for the reporting of suspected adverse reactions by health-care professionals and patients. Forms intended for patients must be designed according to technical criteria conforming to the principles of clear structure and simplified language accessible to the general public; they must be obtainable on the Internet and in pharmacies. The forms must include the information required to enable reports to the authorities to be made by pharmacies or directly by patients, by post, by fax, or electronically.