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REG–29 version 4

Guideline on Assessment of Acceptability of Medicinal Product Names for the Purposes of Marketing Authorisation Procedure

This Guideline supersedes guideline REG-29 version 3 with the effect from January 1 2017.

REG-29_version4.pdf, file type pdf, (517.75 kB)

 

Contents:

  1. Legal sources and related regulations
  2. Medicinal product name – term and general definition
  3. General criteria for the assessment of medicinal product name in relation with its compliance with legal regulations within the scope of marketing authorisation procedure
  4. Special rules for the names of particular types of medicinal products
  5. Preliminary assessment of medicinal product name
  6. Reporting of medication errors related to similarity of product names
  7. Medicinal product name in Braille