List of documents of public interest communicated ex officio

– Regulatory documents regulating the organisation and operation of the National Agency for Medicines and Medical Devices of Romania;

– the organisational structure, the attributions of the structures, the operating schedule and the audience schedule of the National Agency for Medicines and Medical Devices of Romania;

– the full names of the management staff of the National Agency for Medicines and Medical Devices of Romania and of the person responsible for disseminating information of public interest;

– contact details of the National Agency for Medicines and Medical Devices of Romania, namely: its name, headquarters, telephone numbers, fax numbers, e-mail address and website;

– its financial sources, budget and balance sheet, programs and strategies;

– the list containing documents of public interest, the list containing the categories of issued and/or managed documents, according to the law; the list of public procurement contracts of the National Agency for Medicines and Medical Devices of Romania;

– the periodic activity report of the National Agency for Medicines and Medical Devices of Romania, after being published in the Official Gazette of Romania, Part III, according to Art. 5 paragraph (3) of Law 544/2001;

– information of general interest from a public health viewpoint ensuring good information for citizens, within the scope of competence of the National Agency for Medicines and Medical Devices of Romania;

– draft regulatory documents under public debate on the website of the Ministry of Health, initiated by the NAMMDR, according to Law 52/2003 on decisional transparency in public administration, the ways of contesting the decision of the National Agency for Medicines and Medical Devices of Romania in the event that the person considers themselves injured regarding the right of access to the requested information of public interest.

List of documents issued and/or managed by the company’s own activity structures

• Issued and sent documents (correspondence);
• Document input-output registers;
• Reports;
• Presentation and motivation tools, draft regulatory documents;
• Responses to petitions/requests for information of public interest;
• Notices sent to other institutions;
• Internal correspondence notices;
• Agenda and decisions of the management board;
• Agenda of scientific council meetings, scientific council decisions;
• Decisions of the president of the National Agency for Medicines and Medical Devices of Romania;
• Assessment reports, analysis bulletins, approvals, authorisations, certificates, information concerning notifications, out-of-scope notices, periodic check bulletin, test reports;
• Minutes for finding and sanctioning contraventions;
• Minutes of the meetings of the management board/scientific council/committees;
• Minutes of hearings/meetings;
• Regulation for the organisation and operation of the National Agency for Medicines and Medical Devices of Romania;
• The organisational structure of the National Agency for Medicines and Medical Devices of Romania;
• Job descriptions;
• Individual evaluation sheets of the staff’s activity;
• Attendance lists;
• Delivery and receipt minutes;
• Financial and accounting documents, according to the legislation in force;
• The annual draft budget of the National Agency for Medicines and Medical Devices of Romania;
• The approved annual budget of the National Agency for Medicines and Medical Devices of Romania;
• The balance sheet (annual budget execution) and related annexes;
• Invoices;
• Statements regarding inventories of goods;
• Report on the preventive financial control activity;
• Inventory sheets;
• Public procurement documentation;
• Purchase requisitions;
• Legal files pending in the courts;
• Travel orders;
• Employee professional files;
• Retirement files;
• Certificates;
• Press releases, information, clarifications, rights of reply;
• Individual administrative documents;
• Individual employment contracts;
• Archive documents.