GMP: EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures
The EMA has recently published two documents concerning the centralised application procedures for new, generic and hybrid medicinal products. In the Q&A section on its website the European Medicines Agency publishes the most frequently asked questions regarding the procedures of centralised marketing authorisations. The answers are updated as necessary and therefore represent the authority\'s current thinking about the topics concerned.
Źródło wiadomośći: http://www.gmp-compliance.org/eca_news_2790_6957,7031,7000,7017,7201.html