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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variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)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 · 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 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variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)

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Annotations to the whole text

Textual amendments

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Repealed by Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal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 falling within the scope of Council Regulation (EEC) No 2309/93 (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 Scope and definitions Repealed
  2. 1Article 1 Repealed
  3. 2Article 2 Repealed
  4. 3Article 3 Repealed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 Notification procedure for minor variations Repealed
  6. 4Article 4 Repealed
  7. 5Article 5 Repealed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 Approval procedure for major variations Repealed
  9. 6Article 6 Repealed
  10. 7Article 7 Repealed
  11. 8Article 8 Repealed
  12. 9Article 9 Repealed
  13. Signature
  14. Annex I: MINOR VARIATIONS (TYPE I) TO A MARKETING AUTHORIZATION AS REFERRED TO IN ARTICLE 3 (1) Repealed
  15. Introductory statements Repealed
  16. Annex IIChanges to a marketing authorization leading to a new application as referred to in Article 2 Repealed

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Signature

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Introductory statements

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

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