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Part II SPECIFIC MARKETING AUTHORISATION DOSSIERS AND REQUIREMENTSF1

United Kingdom

Original text. Later amendments are not shown.

Some medicinal products present specific features which are such that all the requirements of the marketing authorisation application dossier as laid down in Part I of this Annex need to be adapted. To take account of these particular situations, an appropriate and adapted presentation of the dossier shall be followed by applicants.

  1. 1WELL-ESTABLISHED MEDICINAL USE
  2. 2ESSENTIALLY SIMILAR MEDICINAL PRODUCTS
  3. 3ADDITIONAL DATA REQUIRED IN SPECIFIC SITUATIONS
  4. 4SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
  5. 5FIXED COMBINATION MEDICINAL PRODUCTS
  6. 6DOCUMENTATION FOR APPLICATIONS IN EXCEPTIONAL CIRCUMSTANCES
  7. 7MIXED MARKETING AUTHORISATION APPLICATIONS

Annotations

Textual amendments

F1

Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).