20.05.2011

EMA updates pre-submission and post-authorisation procedural advices

The European Medicines Agency (EMA) has updated their "procedural advice" guidance documents for user of the centralized procedure in the "pre-submission" and "post-authorisation" phase.

Changes included in the updated "pre-submission procedural advice" EMA/339324/2007, May 2011:

Question 4, addressing the criteria for acceptance of the proposed (invented) name from a public health point of view: The criterion "..should not be liable to cause confusion in print, handwriting or speech with the invented name of an existing medicinal product" has been removed
Question 5, addressing the complete name of the medicinal product: The wording of the first paragraph has been slightly revised: The name and the package must be "suitable to ensure identification and differentiation". In the previous version it was just referred to as a "special name" and a "special pack"
Question 23 ("How and to whom shall I submit my dossier?"): Reference to the EMA statement of intend regarding eCTD implementation and reference to the PIM project have both been removed from the text. New reference to the new EMA cover letter template has been included
Question 25 ("When to submit the Marketing Authorisation Application?"): Hyperlink references have now been included to allow for direct navigation to referenced forms and timetables. In addition, the address for the pre-submission request form has been changed to "pa-bus@ema.europa.eu"
Question 45 ("What is PIM") has been changed to take into account that the PIM project has been stopped by EMA in March 2011
Question 47, addressing incentives and assistance for SMEs: Scientific services, certification of quality/non-clinical data for advanced therapy medicinal products for human use, and a waiver of the MedDRA licensing fee have now been included

For details please be referred to the updated pre-submission procedural advice.

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Changes included in the updated "post-authorisation procedural advice" EMEA-H-19984/03 Rev 19, May 2011:

Throughout the text, references to the new EMA cover letter template have been included on pages 18, 25, 38, 52 and 66.
In addition, section 3 (Type II variations) has been updated to reflect implementation of Type II variations not effecting annexes: In section 3.8, addressing post-opinion steps that apply to Type II variations and the time of the implementation of approved changes, a reference to the Procedural Note from the European Commission has been included.

For details please be referred to the updated post-authorisation procedural advice.

[Source: EMA website]

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