Revision
of the Variations Regulation – New Proposal released on 25 October 2002
– New Categories of EU-Variations 1)
The Variation Regulations (EC) 541/95 (1) and (EC) 542/95 (2) are being
revised by the European Commission.
Proposals for changes to these regulations have been prepared by the
Notice to Applicants Group and were released to the industry for comments
in the beginning of February this year (proposed draft 3 of the Revision
of the Variations Regulation). After lots of comments of the
pharmaceutical industry, especially with regard to concerns of the
different variation types into Type I, IIA and IIB, a new proposal was
released to the Notice to Applicants Group, the EMEA, the Working Parties
and the Trade Associations on 25 October 2002. One of the most important
outcomes was that the Type IIA variations should be moved to the annex I
on minor variations. The new proposal of the Variations Regulations now
lists two different Type I variations (Type IA and Type IB) and one Type
II variation – compared to one Type I and two Type II (Type IIA/B)
variations in the former draft (Draft 3) (see Table 1). Type IA and IB
variations follow the notification procedure, but have different
timeframes (see Table 2). New is that Type IA and IB variations are in the
responsibility of the Reference Member States (RMS).
A comparison between the current variation regulation, the proposed
draft 3 and the New Proposal, the timeframes and a short description of
these new types of variations are listed below:
Table 1: Comparion of the types of variation between the current
Variation Regulation, the proposed draft 3 and the New Proposal:
Current
Proposed Draft 3
New Proposal
Type I
Type I A
Type I
Type II A
Type I B
Type II
Type II B
Type II
List of Type I Variations (with 34 entries)
Annex I (Draft 6, list with 52 single entries)
Annex I
Annex II (Draft 1, list with 41 changes)
-
Annex III 'Line Extensions'
Annex II 'Line Extensions'
Table 2: Timeframes of the new proposal for the Variations
Regulation:
Procedure
Timeframe
Definition
Type IA
Notification
max. 14 days
Annex I
Type IB
Notification
'old Type I'
Annex I
Type II
Approval
'old Type II'
-
Extension
Authorisation
see Directive
Annex II
(1) Type IA Variation (Notification)
Type IA variations are a new category of variations that have been
redefined as 'minor' changes which only have to be notified to the
competent authorities. The notification procedure is also called the 'Tell
and do'-procedure and was set out to provide for rapid processing of
variations. Type IA changes that are listed in Annex I are defined as
administrative changes and/or simple changes with no possible impact on
the safety of the medicinal product.
Validation of Type IA variations is done by the Reference Member State
(RMS) in case of the Mutual Recognition Procedures and is done by EMEA in
case of the centralised procedure. In case of the Mutual Recognition
Procedure the RMS will inform the other national competent authorities
concerned and the marketing authorisation holder in the RMS accordingly.
(2) Type IB (the current Type I Variation and the former Type IIA)
The Type IB Variations are the 'minor' changes that implicit approval
within a 30-day waiting period. The evaluation and approval of the
procedure is done by the RMS who will inform the other national competent
authorities concerned and the marketing authorisation holder in the RMS
accordingly.
(Remark: Former Annex II of draft 3 of the Revision of the Variations
Regulation with 42 listed variations for Type IIA is integrated into the
new Annex I).
(3) Type II (the current Type II Variation and the former Type IIB
variations)
The Type II Variations are the 'major' changes that need approval. An
approval has to be waited for (timeframe: 90 days with an option for
changes to indications to extend to 120 days). All possible changes that
are not listed in Annex I are defined as Type II variations.
(4) Extension
New is the fourth category for line extensions that have been legally
defined for the first time in the EU. 'Extension' applies to products with
the same legal name, but where defined changes have been made, e.g.
replacement of the active substance(s) by a different salt/ester complex
or derivative, where the efficacy/safety remains the same, changes to
strenght, pharmaceutical form and route of administration, etc.
What will be the next steps with the Revision of the Variations
Regulation?
On 28 November 2002 there will be a discussion of open points between
the EU-Commission, the Member States (MS), the EMEA and the Working
Parties (WP's). On the next day, 29 November 2002, the members of the
NtA/WP's will discuss open points with the Trade Associations. All in all,
it will be interesting what further 'changes' will be made. Let's look
forward to the finalised document.
The New Proposal of the Variation Regulation will be presented at the 5th CEFIC/APIC European Conference on Active Pharmaceutical Ingredients by
Dr. P. Bachmann, a member of the Notice to Applicants Group. This
conference will take place from 13 to 15 November 2002 in Barcelona/Spain.
Please click here for further information.
Writer:
Dr Barbara Jentges
CONCEPT HEIDELBERG
1) The New Proposal of the Variations Regulation was presented by
Dr. P. Bachmann, BfArM, at the German CONCEPT HEIDELBERG Seminar 'Change
Control Management', 29-30 October 2002 in Heidelberg.
(1) Commission Regulation (EC) No 541/95 of 10 March 1995 (as amended
in 1998), concerning the examination of variations to the terms of a
marketing authorization granted by a competent authority of a Member State
(2) Commission Regulation (EC) No 542/95 of 10 March 1995 (as amended
in 1998), concerning the examination of variations to the terms of a
marketing authorization falling within scope of Council Regulation (EEC)
No 2309/93
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