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NAMMDR

NAMMDR

National Agency for Medicines and Medical Devices of Romania

  • AGENCY
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  • MEDICINES FOR HUMAN USE
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    • Report an adverse reaction
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  • MEDICAL DEVICES
    • Important notifications – Medical Devices
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    • CE marking
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    • Registration of medical devices into the national database
    • Grant of customs notice
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    • Grant of periodic check bulletins
    • Report an incident
    • Designation of EU reference laboratories (EURLs)
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    • Sponsorships – Medical Devices
    • Medical Devices Index
  • INFORMATION FOR THE PUBLIC
    • Management agenda
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      • Name of the person responsible for compliance with provisions of Law 544/2001
      • Application form provided in Law 544/2001
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      • Implementation reports on Law 544/2001
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    • Public procurement
      • Annual schedule of public procurement
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    • 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
> 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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