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

GMP News No. 209

GMP News
1 July 2002

 ProposedChanges to the Variations Regulation - 
 New Categories of EUVariations 

The Variation Regulations (EC) 541/95 1 and (EC) 542/95 2arebeing revised by the European Commission.
Proposals for changes to these regulations have been prepared by theNotice to Applicants Group and were released to the industry for commentsat the beginning of February this year. The planned date for thefinalisation of the proposal is 1 August 2002.

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

(1) Type I Variation (Notification Variation)
Type I Variations have been redefined as 'minor' changes which onlyhave to be notified to the competent authorities and therefore are calledthe 'Tell, wait, then do'-procedure. This procedure – oftenreferred to as Type 0 – is intended to provide for rapid processing ofvariations (time frame 0 to 14 days).
A total of 52 Type I Variations are listed in Annex I to the proposalfor the revision of regulations 541/95 and 542/95 (draft 6). In thecurrent 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 approvalwithin a 30-day waiting period.
42 variations are listed in Annex II to the proposal for the revisionof regulations 541/95 and 542/95 (draft 6). The asterisked Type IVariations among the current Type I Variations (Type I changes for whichType II procedures apply to products covered by Immunological/VeterinaryImmunological Products, Blood Products, High Tech Products concerning87/22/EEC, products concerning Regulation EC 2309/93) are expected tobecome 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 toextend to 90 days). All changes that are not Type I, Type IIA orExtensions, are categorised as Type IIB.

(4) Extension
What is new is the fourth category for line extensions that have beenlegally defined for the first time in the EU. 'Extension' applies toproducts with the same legal name, but where defined changes have beenmade, e.g. replacement of the active substance(s) by a differentsalt/ester complex or derivative, where the efficacy/safety remains thesame, changes to strength, pharmaceutical form and route ofadministration, etc.
For these variations, e.g. the introduction of a new pharmaceuticalform under the Mutual Recognition Procedure, the MA-holder (marketingauthorisation holder) would have to inform the original Reference MemberState about this variation.

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


Dr Barbara Jentges

1 Commission Regulation (EC) No 541/95 of 10 March 1995, concerningthe examination of variations to the terms of a marketing authorizationgranted by a competent authority of a Member State

2 Commission Regulation (EC) No 542/95 of 10 March 1995, concerningthe examination of variations to the terms of a marketing authorizationfalling within scope of Council Regulation (EEC) No 2309/93



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