Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. Procedural advice for orphan medicinal product designation: Guidance for sponsors

    Procedural advice for orphan medicinal product designation: Guidance for sponsors

  2. European Medicines Agency Write PMS API implementation Guide (zip)

    European Medicines Agency Write PMS API implementation Guide (zip)

  3. European Medicines Agency Write PMS API implementation Guide

    European Medicines Agency Write PMS API implementation Guide

  4. 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

  5. Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers

    Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers