Revision of the Variations Regulation - New Proposal released on 25 October 2002 - New Categories of EU-Variations

GMP News No. 258

News
6 November 2002
 

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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