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NAMMDR

NAMMDR

National Agency for Medicines and Medical Devices of Romania

  • AGENCY
    • Press releases
    • Brexit
    • Informative bulletin
    • Programmes and strategies
    • Transparency policy
    • Quality policy
    • Policy for website updates
    • Management
      • Management
      • Management staff
      • Administration Council
      • Scientific Council
    • Organisation
      • Organisational and operational rules and regulations
      • Organisational structure
      • List of employees assigned in working groups
    • About ANMDMR
      • About us
      • Careers
      • Legislation (organisation and operation of the institution)
      • FAQ
  • MEDICINES FOR HUMAN USE
    • Important notifications – Medicines for human use
    • ASN Announcements (Authorizations for Special Needs)
    • 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
    • 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
    • Validation / Verification of registration into the EUDAMED database
    • 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
    • Unique Device Identification system (UDI)
    • Sponsorships – Medical Devices
    • Medical Devices Index
  • INFORMATION FOR THE PUBLIC
    • Management agenda
    • Activity reports
    • Requests for information
      • Law no. 544/2001 on free access to public 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
    • 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

Forms regarding submission for approval of educational materials

Application Form for approval of Educational Materials
download document …

Form Payment of fee for assessment of Educational Materials
download document …

Detailed implementation plan for educational materials
download document …

Pharmacovigilance

> Report an adverse reaction
> Direct healthcare professional communications
> Educational materials
> Risk management plan (RMP)
> Periodic safety update reports (PSURs)
> Safety signals
> Pharmacovigilance referrals
> Post-authorisation safety studies (PASS)
> Medicinal products 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

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