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  • About MEB > Our Work

    • Column by the chairman: 'On medicines'
    • Cooperation in Europe
    • Cooperation in the Netherlands
    • MEB Advisory Board
    • Our story: Good medicines used better
    • Our tasks
    • Science

  • About MEB > The organisation

    • Integrity, openness and finances
    • The Agency
    • The Board
    • Working at the MEB

  • 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
    • Fees and product types
    • Informed consent
    • Legal status of supply
    • Line extension
    • Mutual recognition procedure
    • National procedure
    • Parallel procedures: faster assessment of medicines
    • Pipeline meetings
    • Planning tool for application procedures
    • Renewal
    • Variation
    • Withdrawal of a marketing authorisation

  • Marketing authorisation > MEB policy

    • Animal testing
    • Authorisation Contact Committee (CCR)
    • MEB policy documents
    • Patented indication

  • Marketing authorisation > Pharmacovigilance

    • Decision-making process at the European level
    • Direct Healthcare Professional Communication (DHPC)
    • EudraVigilance signal management pilot
    • 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
    • Labelling
    • Marketing authorisations without Dutch translations of the product information and/or mock-ups
    • Medicine pictograms
    • Nomenclature, excipients, abbreviated indications
    • Package leaflet
    • QR code
    • QRD templates
    • Summary of product characteristics (SmPC)
    • Temporarily supply of a medicinal product in a different packaging

  • Marketing authorisation > Submitting a dossier

    • Correspondence during procedure
    • Cover letter
    • Dossier modules
    • Site clearance
    • Submission via CESP
    • Technical validation
    • TSE requirements

  • Marketing authorisation > Types of marketing authorisation

    • Biosimilar medicinal product
    • Consultation procedure for medical devices
    • Duplex marketing authorisation
    • Generic medicinal product
    • Homeopathic medicinal product
    • Medicinal gas marketing authorisation
    • New active substance
    • Paediatric medicinal product
    • Parallel import
    • Traditional herbal medicinal product
    • Well established use

  • Novel foods

    • 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 procedures
    • Cascade
    • Certificates
    • Clinical trial with a veterinary medicinal product
    • Committee for the Authorisation of Veterinary Medicines (Ctd)
    • Fees and product types Veterinary Medicinal Products Unit
    • Homeopathic veterinary medicinal product
    • Legal status of supply
    • Legislation on veterinary medicinal products
    • Marketing authorisation exemption
    • Parallel distribution
    • Parallel trade in veterinary medicinal products
    • Recall of veterinary medicinal product
    • Registration procedure for specific pets
    • Reporting a product defect
    • SPC, labelling and package leaflet veterinary medicinal products
    • Submission of a dossier
    • Types of marketing authorisation
    • Union Product Database

  • Veterinary medicines > Production and distribution

    • Advertising
    • Committee for the Authorisation of Veterinary Medicines (Ctd)
    • Committee on the authorisation of veterinary medicinal products
    • Database for manufacturing and wholesale distribution (EudraGMDP)
    • Export of veterinary medicinal products
    • Good distribution practice (GDP)
    • Internet trade in veterinary medicinal products
    • Licence requirements for retail (D)
    • Licence requirements for wholesale (G)
    • Licence types
    • Manufacturing (F) (GMP)
    • Opium Act and veterinary medicinal products
    • Organisation Management Service (OMS)
    • Production and/or distribution licence application, change or withdrawal
    • Register of licences
    • Requirements for importation (I)
    • Starting materials
    • Storage, transport and delivery of veterinary medicinal products
    • Veterinary prescription

  • Veterinary medicines > Veterinary pharmacovigilance

    • Committee for the Authorisation of Veterinary Medicines (Ctd)
    • Inspection
    • Pharmacovigilance communication plan
    • PSMF
    • Reporting an adverse event
    • Signal management
Good medicines used better.

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