Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93

COMMISSION REGULATION (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human  or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of  Medicinal Products (1), and in particular Articles 22 (1) third paragraph and 44 (1) third paragraph thereof,
Whereas a number of adverse reactions not described in the summary of products characteristics of the medicinal product may occur and be identified at any time of marketing of a medicinal product;
Whereas Articles 22 (1) and 44 (1) have already provided for reporting of suspected serious adverse reactions to medicinal products for human use and to veterinary medicinal products respectively;
Whereas innovative medicinal products deserve a close pharmacovigilance supervision in the interest of human and animal health, including unexpected, non-serious, suspected adverse reactions, whether arising in the Community or in a third country and  reported to the holders of marketing authorizations by health professionals and also, in the veterinary sector, by other appropriate persons;
Whereas holders of marketing authorizations should where necessary apply for a variation to the marketing authorization when it is confirmed that suspected unexpected adverse reactions not classified as serious are due to the medicinal product in  question;
Whereas the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as 'the Agency') should be responsible for coordinating the activities of the Member States in the field of monitoring of adverse reactions to medicinal  products (pharmacovigilance);
Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committees on Human and Veterinary Medicinal Products,