OpenLegislation

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examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State (repealed)

EU Regulation No 541/1995 · Adopted 10 March 1995 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State (repealed)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations to the whole text

Textual amendments

F1

Repealed by Commission regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (Text with EEA relevance).

Contents

  1. Scope and definitions Repealed
  2. 1Article 1 Repealed
  3. 2Article 2 Repealed
  4. 3Article 3 Repealed
  5. Notification procedure for minor variations Repealed
  6. 4Article 4 Repealed
  7. 5Article 5 Repealed
  8. Approval procedure for major variations Repealed
  9. 6Article 6 Repealed
  10. 7Article 7 Repealed
  11. 7aArticle 7a Repealed
  12. 7bArticle 7b Repealed
  13. 8Article 8 Repealed
  14. Signature
  15. Annex I: MINOR VARIATIONS (TYPE I) TO A MARKETING AUTHORIZATION AS REFERRED TO IN ARTICLE 3 (1) Repealed
  16. Introductory statements Repealed
  17. Annex IIChanges to a marketing authorization leading to a new application as referred to in Article 2 Repealed

1F1

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

2F1

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

3F1

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

4F1

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

5F1

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

6F1

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

7F1

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

7aF1

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

7bF1

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

8F1

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

Signature

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introductory statements

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Annex IIChanges to a marketing authorization leading to a new application as referred to in Article 2F1

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

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

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