Directive 2011/62/EU (‘’Falsified Medicines Directive’’) of 08 June2011 amending Directive 2001/83/EC describes requirements for excipients. e.g.
- Article 46f requires the holder of the manufacturing authorisation to ensure that excipients are suitable for use in medicinal products by ascertaining appropriate good manufacturing practice on the basis of a formalised risk assessment.
- In Article 47 it is stated that the Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients.
EFPIA supports the requirements of the new legislation, but our concern is that its implementation may lead to a proliferation of regulatory guidance. Current regulations, practices and standards, which have been established, for example by the excipient suppliers, medicinal product manufacturers and Pharmacopoeias and which ensure excipient quality, need to be taken into account.