The European Co-ordination group for Mutual Recognition and Decentralised Procedures has recently published a set of Q&As related to QP declaration.

Topics covered in the Q&A include:

  • Whether the QP declaration needs to consider only the final active substance manufacturer site and its intermediate, or if he/she needs to consider the manufacturing sites of the raw-materials used for the first synthesis step (when those sites are only mentioned on the restricted part of the DMF)
  • For CEP updates, when the name of the manufacturing authorization holder changes, even though the site remains the same, the rationale of a new QP declaration is required
  • Impact to the QP declaration when a new API manufacturing site is added in an updated CEP
  • How to handle the scenario where a CEP has 2 manufacturing sites A and B (both sites perform complete manufacture of the API), but approval is only being sought for one of the sites
  • How information on change in Qualified Person should be notified to the National Competent Authorities
  • Which QP declaration(s) are required in support of individual types of changes to a Marketing Authorisation, to confirm that the active substance is manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials as adopted by the Union