23.12.2010

EU: EMA released updated pre-submission procedural advice

The European Medicines Agency (EMA) has released an updated version of their Pre-Submission procedural advice for users of the centralised procedure. The procedural advice addresses typical questions which users of the Centralised Procedure may have. It is intended to provide an overview of the EMA’s position on issues, which are typically addressed during the course of Pre-Submission Meetings with the agency.

The new version from December 2010 contains only a few updates as summarized below:

Question #9: Additional clarification and procedural advice has been provided for the handling of multiple applications for a specific medicinal product
Questions #10 and #12: References to the “Explanatory Note on fees payable to the European Medicines Agency” (EMA/348317/2010) have been updated as these were changed in October this year.
Question #13: The references to the EMA "Public Statement on Fee reductions for Designated Orphan Medicinal Products" (EMEA/63200/2009) has been updated.
Question #37: The procedural advice regarding updates to the information provided in the "Detailed Description of the Pharmacovigilance System" (DDPS) has been updated. Corresponding updates should be "submitted as a variation in accordance to the EC guideline on the details of the various categories of variations. Depending on the changes introduced to the existing DDPS they could fall under C.I.9 a) to e); however if none of the pre-specified options apply then it could be submitted as default type IB C.I.9 z) as listed in the Variation Application Form. In case of the introduction of a new DDPS, such change will fall within the category C.I.8 and the variation, as appropriate, should be submitted."

The updated pre-submission procedural advice is available as online FAQ and as downloadable PDF version (see link at the bottom of this article).

[Source: EMA website]

Links:

www.ema.europa.eu/ema/index.jsp

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