At the beginning of the year, the EMA published the "Guideline on Active Substance Master File Procedure" as a revised document with an 8-week deadline for comments. After having been accepted by the Quality Working Party, the CVMP and the CHMP, the finalised version of the guideline was released on the EMA website.
The document is supposed to help accomplishing an administrative harmonisation which should facilitate the processing of an ASMF by authorities and improve communication between the ASMF holder, the applicant and the assessors of the authorities concerned (for more details about this guideline please read our News from 1 February 2012). The comparison of the final document with the draft published at the beginning of this year shows that only a few changes have been made. Most of them are textual ones. Yet, a supplement in the title text of the Guideline should be mentioned as it refers to renewal of a marketing authorisation which has to be made after 5 years. In this event, marketing authorisation holders are required to: "....declare that the quality of the product, in respect of the methods of preparation and control, has been regularly updated by variation procedure to take account of technical and scientific progress, and that the product conforms with current CHMP/CVMP quality guidelines. They will also declare that no changes have been made to the product particulars other than those approved by the Competent Authority/EMA."
This requirement - according to which the confirmation has to be brought that the quality standards of the medicinal product are maintained in case of a renewal of the marketing authorisation - is new.
Further changes can also be found in the final Guideline:
- Annex 2: Template Letter of Access. Name and address of the production site of the API manufacturer are not required.
- Annex 3: Template Submission Letter and Administrative Details for documents relating to an Active Substance Master File: a national ASMF reference number must be indicated. In addition, GPS coordinates of the site of the API manufacturer or its DUNS number must be specified (through the systematic of the Data Universal Numbering System, DUNS, each manufacturing site receives a number which enables unique identification)
- Annex 4: Template Withdrawal of Access Letter: the reason for withdrawal must be named. One of two options can be selected: either "The API manufactured in accordance with the above Active Substance Master File will no longer be supplied" or "Replacement of the Active Substance Master File by Certificate of Suitability, CEP".
The Guideline is coming into force on 1st October 2012. Marketing authorisation holders, ASMF holders as well as authorities have still some time left to get familiarized with the new requirements of the "Guideline on Active Substance Master File Procedure".
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)