28 May 2012

Exalon: EMA issues new version of the Post-authorization procedural advice for users of the Centralized Procedure

The European Medicines Agency (EMA or the Agency) has released a further update of their "Post-authorization procedural advice for users of the centralized procedure", document EMEA-H-19984/03.

The current revision 23 contains only two notable updates:

   1. Question 1.8 dealing with the fees applicable for Type IA/IAIN variations: The Agency will now issue an invoice upon receipt of the Type IA/IAIN variation and fees must be paid within 45 calendar days of the date of the said notification. Previously the invoice was issued by the Agency on the date of the notification of the review outcome to the applicant.

   2. Question 18.4 dealing with changes in contact persons mentioned in the application form: This question contains now explicit detailed explanations how to deal with a change to the contact person at the MAH address (section 2.4.1 of the application form) or with a change to the person/company authorised for communication between the MAH and the Agency (sections 2.4.2 and 2.4.3 of the application form).

To find more information please use the below mentioned Exalon weblink 

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