Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)
  1. Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
  2. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
  3. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
  4. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
  5. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes