# Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)

EU Regulation No 542/1995 · adopted 10 March 1995

Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)

PDFs: Printed copy https://openlegislation.uk/eu-regulation-1995-542/pdf/eur_19950542_adopted_en.pdf; Revised version (1 October 2003) https://openlegislation.uk/eu-regulation-1995-542/pdf/eur_19950542_2003-10-01_en.pdf; Revised version (30 May 1998) https://openlegislation.uk/eu-regulation-1995-542/pdf/eur_19950542_1998-05-30_en.pdf

## Introductory text

Commission Regulation (EC) No 542/95
of 10 March 1995
concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Scope and definitions

## 1 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 2 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 3 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Notification procedure for minor variations

## 4 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 5 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Approval procedure for major variations

## 6 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 7 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 8 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 9 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Signature

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Annex I: MINOR VARIATIONS (TYPE I) TO A MARKETING AUTHORIZATION AS REFERRED TO IN ARTICLE 3 (1)

## Introductory statements

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Annex II Changes to a marketing authorization leading to a new application as referred to in Article 2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---
Source: https://www.legislation.gov.uk/eur/1995/542 (the official version)
Page: https://openlegislation.uk/eu-regulation-1995-542
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.