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NAMMDR

NAMMDR

National Agency for Medicines and Medical Devices of Romania

  • AGENCY
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  • MEDICINES FOR HUMAN USE
    • Important notifications – Medicines for human use
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    • Legislation – Medicines for human use
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    • Medicinal product authorisation
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    • Report an adverse reaction
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    • Inform on medicinal product shortage
    • Medicinal products under additional monitoring
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  • MEDICAL DEVICES
    • Important notifications – Medical Devices
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    • 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
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    • 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
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    • Status of wage payment and other rights
    • Public procurement
      • Annual schedule of public procurement
      • Summary of public procurement
      • Public procurement contracts
    • Declarations of interest
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    • NAMMDR policy for webpage
    • The IT&C Security policy
  • CONTACT
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  • RO

Medicinal products under additional monitoring

Medicines under additional monitoring
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Guideline on good pharmacovigilance practices (GVP),Module X – Additional monitoring
download document …

List of medicines under additional monitoring
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What does the black triangle mean?
download document …

Care este semnificatia triunghiului negru?

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

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