Proposed Changes to the Variations Regulation - New Categories of EU Variations

GMP News No. 209

GMP News
1 July 2002
 

 Proposed Changes to the Variations Regulation - 
 New Categories of EU Variations 

 
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 at the beginning of February this year. The planned date for the finalisation of the proposal is 1 August 2002.

The proposal for a revision of the Variations Regulations lists four different categories of variations as summarised below:

(1) Type I Variation (Notification Variation)
Type I Variations have been redefined as 'minor' changes which only have to be notified to the competent authorities and therefore are called the 'Tell, wait, then do'-procedure. This procedure – often referred to as Type 0 – is intended to provide for rapid processing of variations (time frame 0 to 14 days).
A total of 52 Type I Variations are listed in Annex I to the proposal for the revision of regulations 541/95 and 542/95 (draft 6). In the current list there are 34 Type I Variations.

(2) Type II A (the current Type I Variation)
The Type IIA Variations are the 'minor' changes that implicit approval within a 30-day waiting period.
42 variations are listed in Annex II to the proposal for the revision of regulations 541/95 and 542/95 (draft 6). The asterisked Type I Variations among the current Type I Variations (Type I changes for which Type II procedures apply to products covered by Immunological/Veterinary Immunological Products, Blood Products, High Tech Products concerning 87/22/EEC, products concerning Regulation EC 2309/93) are expected to become a Type IIA Variation.

(3) Type IIB (the current Type II Variation)
The Type IIB Variations are the 'major' changes that explicit approval. An approval has to be waited for (time frame: 60 days with an option to extend to 90 days). All changes that are not Type I, Type IIA or Extensions, are categorised as Type IIB.

(4) Extension
What is 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 strength, pharmaceutical form and route of administration, etc.
For these variations, e.g. the introduction of a new pharmaceutical form under the Mutual Recognition Procedure, the MA-holder (marketing authorisation holder) would have to inform the original Reference Member State about this variation.

All in all, it will be interesting what comments industry will make on the proposal for the revision of the Variation Regulation and how the European Commission will react to them. Let us look forward to August this year …

The new Variation Regulation will be among the topics of the Regulatory Affairs Part of the 5th CEFIC/APIC European Conference on Active Pharmaceutical Ingredients that takes place from 13 to 15 November 2002 in Barcelona/Spain. Please click here for further information.

Writer:
Dr Barbara Jentges
CONCEPT HEIDELBERG

1 Commission Regulation (EC) No 541/95 of 10 March 1995, 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, 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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