EN PL
  1. www.sciencepharma.com
  2. News
  3. EU Law
  4. EMEA: Addition of questions to pre-submission guidance (Q50, 51, 52)

EMEA: Addition of questions to pre-submission guidance (Q50, 51, 52)

15.06.2009
  • What is the Community Plasma Master File certification system?
  • What is the Community Vaccine Antigen Master File certification system?
  • What is Eudravigilance? How will it apply to my Marketing Authorisation?
The source of the news: http://www.emea.europa.eu/htms/human/presub/list.htm