Marketing authorisation > Availability and shortages
- GMP and quality defects
- Marketing authorisation for reasons of public health
- Marketing discontinuation, suspension and shortages
- Proposed withdrawals and patients' interest
Marketing authorisation > Marketing authorisation procedures
- Centralised procedure
- Decentralised procedure
- Informed consent
- Legal status of supply and OTC medicinal products
- Line extension
- Mutual recognition procedure
- National procedure
- Product types and fees
- Renewal
- Variation
- Withdrawal of a marketing authorisation
Marketing authorisation > MEB policy
Marketing authorisation > Pharmacovigilance
- Decision-making process at the European level
- Direct Healthcare Professional Communication (DHPC)
- National contact person for pharmacovigilance
- Periodic safety update reports (PSUR)
- Reporting adverse events
- Responsibilities following marketing authorisation
- Risk management plan
Marketing authorisation > Prior to marketing authorisation application
- Application procedure advisory meetings
- Compassionate use programme
- Reporting adverse events during clinical trials
- Scientific and regulatory advice
Marketing authorisation > Product information requirements
- Falsified Medicines Directive
- Implementation of agreed wording product information
- Labelling
- Marketing authorisations without Dutch translations of the product information and/or mock-ups
- Nomenclature, excipients, abbreviated indications
- Package leaflet
- QR code
- QRD templates
- Summary of product characteristics (SmPC)
Marketing authorisation > Submitting a dossier
- Correspondence during procedure
- Cover letter
- Dossier modules
- MEB Portal
- Site clearance
- Submission via CESP
- Technical validation
- TSE requirements
Marketing authorisation > Types of marketing authorisation
- Biosimilar medicinal product
- Duplex marketing authorisation
- Generic medicinal product
- Homeopathic medicinal product
- Medical device consultation procedure
- Medicinal gas marketing authorisation
- New active substance
- Paediatric medicinal product
- Parallel import
- Traditional herbal medicinal product
- Well established use
Novel foods
- Assessment reports
- Definition of novel foods
- Determination of novel food status
- European authorisation procedure
- Relevant legislation
Veterinary medicines > Animal feeds
- Animal feed additives
- Animal feed claims
- Dietetic feeds
- Feed materials
- Permission to carry out tests with additives for animal feed
- Register of animal feed additives
- Use of herbs in animals
Veterinary medicines > Marketing authorisation
- Application for parallel distribution
- Application procedures
- Cascade
- Certificates
- Fees and product types Veterinary Medicinal Products Unit
- Legal status of supply of veterinary medicinal products
- Marketing authorisation application homeopathic veterinary medicinal product
- Marketing authorisation exemption
- Parallel importation marketing authorisation
- Recall of veterinary medicinal product
- Reporting a product defect
- SPC, labelling and package leaflet veterinary medicinal products
- Submission of a dossier
- Sunset clause veterinary medicines
- Testing exemption application for veterinary medicinal products
- Types of marketing authorisation
Veterinary medicines > Production and distribution licences
- Advertising
- Export of veterinary medicinal products
- Licence requirements for retail (D)
- Licence requirements for wholesale (G)
- Licence types
- Manufacturing (F) (GMP)
- Possession of raw materials
- Production and/or distribution licence application, change or withdrawal
- Register of licences
- Requirements for importation (I)
- Storage, transport and delivery of veterinary medicinal products