Synapse - referral
Article 31 referrals
Status: CHMP opinion
Opinion/position date:
Last updated:
ReferralHuman
Biologicals: finished product

The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

Last updated:
HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
Synchron - referral
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Rubraca - referral
rucaparib
Article 20 procedures
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Biologicals: active substance
Last updated:
HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines