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National Agency for Medicines and Medical Devices of Romania

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In-use surveillance

Specific legislation

LAW no. 95/2006 on healthcare reform, republished as amended, Article 933
Article 935
Article 933
Article 936

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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