QP Declaration vs. GMP Certificate

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a group of the Heads of Medicines Agencies (HMA),  has updated its Questions & Answer Document on Applications for Marketing Authorisation (CMDh/268/2012).

The latest amendment is dealing with the question whether a member state can invalidate a procedure because a GMP Certificate was not provided for an API for which the QP declaration was provided.

The answer is: "No. A satisfactory QP Declaration is always necessary and is normally sufficient to confirm that the manufacture of active pharmaceutical ingredients (APIs) comply with Good Manufacturing Practice (GMP), as required by Article 8 Paragraph 3 (ha) of Directive 2001/83/EC."