Member Login

    
              Click here if you forgot your password.

Current Events

Webinar: The new Annex 21

Tuesday, 21 April 2020
14.30 - 16.00 h

Webinar: The new EMA Reflection Paper on GMP and Marketing Authorisation Holders

Thursday, 23 April 2020
14.00 - 15.30 h


EQPA Members Area

IMP Working Group Members Area


Document and track your personal development - with the Continuous Professional Development (CPD) Documentation Template

To access the template for documenting and tracking your past and ongoing activities, please go here.

After filling out the form, you will be able to create and print out a PDF file.

QP Declaration vs. GMP Certificate

19/02/2014

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."


 

Conference Recommendations