Annex IV - Discussion meeting with applicant - molecule-independent device bridging approach (MIDBA)
Annex I - Briefing document - molecule-independent device bridging approach (MIDBA)
Annex III - Written responses to list of issues - molecule-independent device bridging approach (MIDBA)
Annex II - Initial Qualification Opinion List of Issues - molecule-independent device bridging approach (MIDBA)
Draft qualification opinion for molecule-independent device bridging approach (MIDBA)
Draft guideline on quality aspects of phage therapy medicinal products
PSUSA/00010468/202501
PSUSA/00009084/202412
PSUSA/00000745/202412
Herbal medicinal product: Primulae radix, Primula veris L.,Primula elatior (L.) Hill, F: Assessment finalised