Compliance with good manufacturing practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorisation. Likewise, the manufacture of investigational medicinal products must be in accordance with GMP. Advanced therapy medicinal products that are administered to patients under Article 3(7) of Directive 2001/83/EC1 (so called “hospital exemption”) must be manufactured under equivalente quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorisation.
- EMA new guidelines on veterinary pharmacovigilance
- Veterinary product information templates
- MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system
- The FDA finalized its guidance on the form and content requirements for unique device identifiers (UDI)
- 4th Edition of the ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
- Fichas informativas com informação básica para todos os stakeholders sobre os novos Regulamentos dos Dispositivos Médicos e Dispositivos Médicos para o diagnóstico in vitro
- EXPAMED CECP (Opinion in the context of Cllinical Evaluation Consultation Procedure).
- EMA has published version 2.1 of the Implementation Guide for the ISO IDMP standards