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.
- Applying in parallel with an EU marketing authorisation application
- Notified bodies’ audits performed in the context of quality management system assessment
- FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.
- Calendário de formações 2021
- IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020
- Register medical devices to place on the market
- 14ª Edição da formação sobre as BPD: “Uma revisão abrangente da temática ,que combina a legislação com casos práticos”
- Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025