Name of the person responsible for compliance with provisions of Law 544/2001 is expert gr. IA Ioana Ivănoiu.
- AGENCY
- MEDICINES FOR HUMAN USE
- Important notifications – Medicines for human use
- ASN Announcements (Authorizations for Special Needs)
- 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
- Pharmaceutical inspection
- Advertising
- Readability
- Standard terms
- Intra-Community deliveries notifications
- Drug discontinuity notifications
- Serialisation
- 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 into the EUDAMED database
- 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
- Issuance of free-sale certificates
- Report an incident
- Report an interruption or discontinuation
- Falsified EC certificates of conformity / Falsified copies of EC certificates of conformity issued by Notified Bodies
- Designation of EU reference laboratories (EURLs)
- Safety communications
- Unique Device Identification system (UDI)
- Sponsorships – Medical Devices
- Medical Devices Index
- INFORMATION FOR THE PUBLIC
- Management agenda
- Activity reports
- Requests for information
- Law no. 544/2001 on free access to public information
- Government Decision No. 123/2002 for the approval of the Methodological Rules for the enforcement of Law 544/2001 on free access to information of public interest
- President Decision no. 175/2019 – List of exempted information
- Name of the person responsible for compliance with provisions of Law 544/2001
- Application form provided in Law 544/2001 on free access to information of public interest, as further amended and supplemented
- Challenge of decisions and associated forms for administrative complaint
- List of documents of public interest and list of documents issued/managed by the institution
- Implementation reports on Law 544/2001
- Budget and funding source
- Balance sheet
- Status of payments (budget execution)
- Status of wage payment and other rights
- Public procurement
- Declarations of interest
- Financial disclosure statements
- The IT&C Security policy
- CONTACT
- RO