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Topics - Marketing authorisation medicines for human use
Topics Marketing authorisation – medicines for human use
A
Animal testing
Application procedure advisory meetings
Authorisation Contact Committee (CCR)
B
Biosimilar medicinal product
C
Centralised procedure
Compassionate use programme
Consultation procedure for medical devices
Correspondence during procedure
Cover letter
D
Decentralised procedure
Decision-making process at the European level
Direct Healthcare Professional Communication (DHPC)
Dossier modules
Duplex marketing authorisation
E
EudraVigilance signal management pilot
F
Falsified Medicines Directive
Fees and product types
G
Generic medicinal product
GMP and quality defects
H
Homeopathic medicinal product
I
Implementation of agreed wording
Informed consent
L
Labelling
Legal status of supply
M
Marketing authorisation for reasons of public health
Marketing authorisations without Dutch translations of the product information and/or mock-ups
Marketing discontinuation, suspension and shortages
MEB policy documents
Medicinal gas marketing authorisation
Mutual recognition procedure
N
National contact person for pharmacovigilance
National procedure
New active substance
Nomenclature, excipients, abbreviated indications
P
Package leaflet
Paediatric medicinal product
Parallel import
Parallel procedures: faster assessment of medicines
Patented indication
Periodic safety update reports (PSUR)
Pipeline meetings
Planning tool for application procedures
Proposed withdrawals and patients' interest
Q
QR code
QRD templates
R
Renewal
Reporting adverse events
Reporting adverse events during clinical trials
Responsibilities following marketing authorisation
Risk management plan
S
Scientific and regulatory advice
Site clearance
Submission via CESP
Summary of product characteristics (SmPC)
T
Technical validation
Temporarily supply of a medicinal product in a different packaging
Traditional herbal medicinal product
TSE requirements
V
Variation
W
Well established use
Withdrawal of a marketing authorisation