Common Contracts
1 similar null contracts
Agreement No.: CN-2368November 6th, 2018
Regulation (EC) n° 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMA) stipulates that EMA “shall be responsible for co-ordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products” (Article 55). In particular, EMA shall undertake the co-ordination of the monitoring, under practical conditions of use, of medicinal products which have been authorised within the Union (Article 57.1(c)), and the “co-ordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose” (Article 57.1(r)).
