European Commission

1. Directive 2001/83/EC of 6 November 2001 on the Community Code relating to medicinal products for human use, available at

2. Regulation (EEC) No. 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, available at http://

3. Commission Regulation (EC) No 540/95 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 authorised in accordance with the provisions of Council Regulation (EEC) No. 2309/93, available at

4. The Rules Governing Medicinal Products in the European Union, Volume 9: Pharmacovigilance, available at http://pharmacos.eudra .org/F2/eudralex

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