EUDRALEX VOL 4 Flashcards
1
Q
What is Eudralex Volume 4 and how is it structured
A
eu legislation of GMP for medicinal product for human and veternairy use.
chapter 1-9 general provision that all company must comply to
active substance as starting materials
GMP related documents q9, q10 annex-19 – company must comply to the ones that are relevant to them
GMP requirements for advanced therapy medicinal product
