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Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use

Short Title:
GMP for Excipients
Origin/Publisher:

European Commission, Official Journal of the European Union

Content:
These guidelines apply to the risk assessment for ascertaining the appropriate GMP for excipients for medicinal products for human use. According to Article 1(3b) of Directive 2001/83/EC, an excipient is any constituent of a medicinal product other than the active substance and the packaging material

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