Skip to content
NAMMDR

NAMMDR

National Agency for Medicines and Medical Devices of Romania

  • AGENCY
    • Press releases
    • Brexit
    • Informative bulletin
    • Programmes and strategies
    • Quality policy
    • Management
      • Management
      • Management staff
      • Administration Council
      • Scientific Council
    • Organisation
      • Organisational and operational rules and regulations
      • Organisational structure
      • Careers
      • List of employees assigned in working groups
    • About ANMDMR
      • About us
      • Legislation (organisation and operation of the institution)
      • FAQ
  • MEDICINES FOR HUMAN USE
    • Important notifications – Medicines for human use
    • ASN Announcements (Authorizations for Special Needs) according to OMS 1351/21.07.2021
    • Legislation – Medicines for human use
    • Forms and tariffs – Medicines for human use
    • Medicinal product authorisation
    • Information about nitrosamines for MAHs
    • Parallel import authorisation
    • Health technologies assessment
    • Clinical trials
    • Last resort treatments
    • Pharmacovigilance
    • Report an adverse reaction
    • Direct healthcare professional communications
    • Submit a medicinal product quality complaint
    • Inform on medicinal product shortage
    • Medicinal products under additional monitoring
    • Pharmaceutical inspection
    • Advertising
    • Readability
    • Standard terms
    • Intra-Community deliveries notifications
    • Drug discontinuity notifications
    • Serialisation
    • Sponsorships – Medicines for human use
    • Medicinal Product Index
    • Counterfeiting
  • MEDICAL DEVICES
    • Important notifications – Medical Devices
    • Legislation – Medical Devices
    • Forms and fees – Medical Devices
    • CE marking
    • Definitions and classification of medical devices
    • Registration of medical devices into the national database
    • Grant of customs notice
    • Grant of donation notice
    • Issuance of an out-of-scope notice
    • Vigilance
    • Market surveillance
    • In-use surveillance
    • Clinical investigation
    • Notified bodies
    • Operation permits
    • Grant of notice for use
    • Grant of periodic check bulletins
    • Report an incident
    • Designation of EU reference laboratories (EURLs)
    • Safety communications
    • Sponsorships – Medical Devices
    • Medical Devices Index
  • INFORMATION FOR THE PUBLIC
    • Management agenda
    • Activity reports
    • Requests for information
      • Name of the person responsible for compliance with provisions of Law 544/2001
      • Application form provided in Law 544/2001
      • Challenge of decisions and associated forms for administrative complaint (refusal and failure to comply with legal deadlines)
      • Public documents and NAMMDR managed/generated documents
      • Implementation reports on Law 544/2001
    • Budget and funding source
    • Balance sheet
    • Status of payments (budget execution)
    • Status of wage payment and other rights
    • Public procurement
      • Annual schedule of public procurement
      • Summary of public procurement
      • Public procurement contracts
    • Declarations of interest
    • Financial disclosure statements
    • NAMMDR policy for webpage
    • The IT&C Security policy
  • CONTACT
    • Contact data
    • Bank accounts and Fiscal code
    • Media relations
    • Business hours
    • Contact persons
    • Audience form
    • On-line enquiries/requests
    • Upload platform
    • Useful links
  • RO

DHPC and Communication plan templates

Direct healthcare professional communications (DHPC) template
download document …

Communication plan template
download document …

Pharmacovigilance

> Report an adverse reaction
> Direct healthcare professional communications
> Medicines under additional monitoring
> Questions and answers on medicinal product safety
> Information for marketing authorisation holders
> Pharmacovigilance specific legislation
> Reporting adverse reactions by citizens of Ukraine
> Educational materials
> Risk management plan

Search the site

Copyright © 2000-2020 - National Agency for Medicines and Medical Devices of Romania | Cookie Policy | Contact ANMDMR
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.I agreeRead more