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NAMMDR

National Agency for Medicines and Medical Devices of Romania

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  • INFORMATION FOR THE PUBLIC
    • Requests for information. Legislation
      • 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
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      • Budget and funding source (as of year 2016)
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  • RO

Pharmaceutical inspection

> Romanian manufacturers – Medicinal products and active substances

> NAMMD certified manufacturers in third countries

> Import authorised sites

> Wholesale authorised sites

> Medicinal product control laboratories

> Withdrawn/Recalled medicinal product batches

> NAMMD certified/Qualified Persons

> NAMMD penalised sites

> EudraGMP

Agency

> Programmes and strategies
> Activity reports
> Informative Bulletin
> Press releases
> FAQ
> Counterfeiting
> Facebook

Medicines for human use

> Important notifications – Medicines for human use
> Legislation – Medicines for human use
> Forms and tariffs – Medicines for human use
> Medicinal product authorisation
> Parallel import authorisation
> Health technologies assessment
> Clinical trials
> Last resort treatments
> Pharmacovigilance
> Report an adverse reaction
> Direct healthcare professionals 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
> Sponsorships – Medicinal products for human use
> Index of medicinal products for human use

Medical Devices

> Important notifications – Medical Devices
> Legislation – Medical Devices
> Forms and fees – Medical Devices
> European regulations on 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
> Grant of out-of-scope notice
> Vigilance
> Market surveillance
> In-use surveillance
> Clinical investigation
> Notified bodies
> Operation notice
> Record of EU/EEA service providers into the database
> Grant of notice for use
> Grant of periodic check bulletin
> Report an incident
> Sponsorships – Medical Devices
> National database for medical devices

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