28.03.2011

EU: New revision of the Post-Authorisation Procedural Advice for the Centralized Procedure released by EMA

The European Medicines Agency has released a new version of the 'Post-Authorisation Procedural Advice Human Medicinal Products' applicable for human medicinal products in scope of the Centralized Procedure. The new revision 18 from March 2011 includes the following changes (short info, for details be referred to the procedural advice):

Type IA variations:

Q4 updated to add reference to the recently released pre-notification checklist
Q10 updated to further specify the procedure to obtain marketing authorisation sub-numbers from the Agency in case of Type IA_IN applications concerning an additional presentation. In this specific case the new EU marketing authorisation sub-number should be requested from the Agency before implementation. Requests should be sent together with a draft Annex A (in English only) to the Procedural office (H-QM-PRO@ema.europa.eu) with a copy to the product shared mailbox and should be made at least 5 working days in advance of the intended submission of the variation. Once a number has been allocated, this number should subsequently be included in the Annex A and product information annexes together with the Variation notification.

Type IB variations:

Q10 update to further specify the procedure to obtain marketing authorization sub-numbers for additional presentations in case of a Type IB application. For corresponding changes see Q10 for Type IA variations above.

Transfer of Marketing Authorizations:

Q12 was updated concerning changes to the Detailed Description of the Pharmacovigilance System (DDPVS) as part of a transfer or Marketing Authorization application. Additional clarification has been provided that any change to the DDPVS due to the transfer procedure requires a separate variation application. The exception are changes to the Qualified Person for Pharmacovigilance which can be included in the Transfer of Marketing Authorization Application.

Other:

Q4 updated that addresses changes to the contact person as detailed in sections 2.4.1 - 2.4.5 and 2.5.1.1 of the application form. Any of the above changes should be be addressed to the Product and Application Business Support (PA-BUS). Usage of the corresponding template form is recommended.
Q5 was updated to reflect the current stage of eCTD implementation at the Agency. Clarification has been added that the eCTD is the only acceptable electronic submission format for all applications and submission types to the Agency.

The new revision 18 of the Post-Authorization Procedural Advice is available for download from the Agency`s website (see link at the bottom of this article).

[Source: European Medicines Agency]

Links:

www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf

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