Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

    Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

  2. List of centrally authorised products requiring a notification of a change for update of annexes

    List of centrally authorised products requiring a notification of a change for update of annexes

  3. 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

    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