![]() EU-M4all provides that the Agency can give a scientific opinion, in the context of cooperation with the WHO, for the evaluation of certain medicinal products intended exclusively for markets outside the European Community. The Agency also certifies products for use outside the European Union. For further information on manufacturing sites certified by the Agency, please see the information package below. The certificates also confirm the good manufacturing practice (GMP) compliance status of the manufacturing site(s) producing the medicinal product bulk pharmaceutical form. ![]() It was previously known as the Article 58 procedure, as the legal basis is Article 58 of Regulation (EC) No 726/2004. As foreseen by the legislation, the Agency's certification scheme is based on World Health Organisation recommendations.ĮMA issues such certificates on behalf of the European Commission to confirm the marketing authorisation status of products either authorised by the European Commission through the centralised procedure or products for which a centralised application has been submitted to the Agency, and products for use outside the European Union (EU-M4all). The legal bases are Article 127 of Directive 2001/83/EC ( medicinal product for human use) and Article 98 of the Regulation 2019/6 (veterinary medicinal products).
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