RSS European Medicines Agency (EMA) | Regulatory and procedural guidelines (human and veterinary)

The European Medicines Agency (EMA) provides regulatory and procedural guidelines for both human and veterinary medicines. These guidelines are designed to help applicants and marketing authorisation holders navigate the regulatory framework for medicinal products in the European Union. The guidelines cover various aspects such as legislation, procedures for European Union guidelines, and related documents within the pharmaceutical legislative framework. They also include information on the centralised procedure for the authorisation and supervision of medicinal products, as well as practical considerations on the impact of new pharmaceutical legislation on marketing authorisation applications. The guidelines are periodically updated to reflect the latest regulatory developments and ensure compliance with EU legislation.