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- AGENCY
- MEDICINES FOR HUMAN USE
- Important notifications – Medicines for human use
- ASN Announcements (Authorizations for Special Needs) according to OMS 1351/21.07.2021
- 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
- Medicinal products under additional monitoring
- Pharmaceutical inspection
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- 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
- 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)
- 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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