Comments to Commision Regulation proposal concerning the examination of variations in marketing authorisation and registration dossier

Mr Nicolas Rossignol
European commission,
Unit F2 ”Pharmaceuticals”
DG Enterprise and Industry
B-1049 Brussels

Bratislava 4th January 2008

Subject: Comments to Commision Regulation proposal concerning the examination of variations in marketing authorisation and registration dossier

Dear Mr. Rossignol,

     We appreciate the opportunity to comment on the proposals for a new Variations Regulation as published in the ”Public Consultation Paper - Better Regulation of Pharmaceuticals: towards a simpler, clearer and more flexible framework on variations” on 24 October 2007. We welcome an update of the current framework for the variation procedures in order to reduce the administrative burden both for the applicants/ MAHs and regulatory authorities.
Having in mind the overall objective, the simplification of the processes, SIDC would like to present following comments:

Key item 1: Purely national Authorisations
We agree with the principle of use of the "Regulation on Variation" for all types of registered products/ procedures, national and EU ones.

Key item 3: ‘Do&Tell’ procedure
We agree with the suggested ’Do&Tell’procedure and the annual reporting of the defined Type I A variations.
Taking into consideration an independent life of a single MA in Slovakia, we are in favour of an annual report containing either several type IA variations for one MA or in case of one annual report for several MAs the set of variations/content should be identical. Further comments regarding the grouping are presented in the text below.
A concentrated workload regarding the annual reports around the end of the year should be avoided. This should be addressed in the legal text. Would a use of a harmonised birthday be a suitable tool?
The timeframe for acknowledgement of receipt for a ’Do&Tell’ procedure should be clarified.

Key item 4: “Work-sharing”:
We welcome the work-sharing proposal as an opportunity to reduce of the workload of the regulatory authorities. Having in mind the responsibilities, qualification and experience of the CMD with MRP and DCP procedures, SIDC would however propose to consider the role of the CMD as a coordinating body for national, MRP and DCP procedures.

Key item 5: Type IB by default
Type IB by default instead of Type II:

SIDC has some concerns regarding the classification Type IB by default instead of Type II, particlularly regarding the repated handling of variations not properly classified at first contact and also the 30-day timeframe to assess the appropriatness of the classification seems to be a challenge.
We would therefore suggest to further develop the set of definitions for Type IB and keep the Type II as default.
Note :In the article 9., 13. and 18., paragraph 5 there is a recommendation the variation which is not laid down in the detailed guideline should be evaluated in accordance with the procedure laid down in paragraphs 2 to 5 of Article 10, 14 and 19, it is as Type II variation.

Other proposals:
Grouping (other than Type IA)
The proposal is welcomed from administrative and scientific perspective – it is considered an advantage to handle and assess the changes in one application/documentation.
However we are of the opinion that handling of grouped variations shall require a strong IT support so that the benefit for the regulatory authority would not turn to become a burden of copying and tracking of changes and documentation. We consider a sufficient timeframe to put the grouping into practice as very important to allow a development of new electronic documentation tracking tools.

Downgrading of variations classification:
We have a concern, whether an additional complexity introduced to the decision tree of variation types would not be rather a burden than simplification.
From our practice and experience with previous Regulation and its understanding we would like to submit some comments to make the rules more clear:

  1. Article 5: Scientific recommendation on unforeseen variations
    Does this article apply only to Centralised procedures?

  1. Article 10, 14 and 19: "Prior Approval" procedure for Type II variations
    Second subparagraph in paragraph 2. - What is the time frame for acknowledgement of receipt?

  1. Note: Article 3: Definitions
    Add point 12. – Updated dossier, CTD format
    Many times the holders ask question, if the update of dossier can be submitted as a variation Typu II or they straightly send it to us as variation type II. We propose to make a note in the definitions, that the updated dossier is not a variation. On the other hand it is point for the discussion, if the updated dossier should be accepted by the national authority at all. Because nobody in the national authority checks the updated document. The holder can put different informations in the new updated version of dossier never assessed by the national authority. Problems can arrise durring the market surveillance, e.g with different not agreed specifications of the product.

Ján Mazag

Annex: Comments...

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