The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products handles all matters relating to:
Medicinal products can only be placed on the market after the competent authority has issued the relevant decision on the marketing authorisation of the medicinal product.
Before issuing such a decision, the competent authority examines whether the medicinal product is of sufficient quality, safe and effective. The assessment shall be made on the basis of the application submitted by the marketing authorisation holder and the documentation attached to it.
The relevant decision-making bodies are the President of the Registration Office and the European Commission.
The decision on the marketing authorisation of medicinal products registered through the national procedure, the mutual recognition procedure and the decentralised procedure is issued by the President of the Registration Office.
The European Commission issues a marketing authorisation for medicinal products registered via the centralised procedure.
Before being placed on the market, Medical Devices must be notified by means of a notification or notification. Notification is required for Medical Devices that are being introduced into the European Union for the first time. The notification shall be made by the manufacturer of the Medical Device, if established within the EU, or by the authorised representative, if the manufacturer is outside the EU. Notification is made by the importer or distributor.
The registration of a veterinary medicinal product is based on the evaluation of the dossier submitted by the responsible entity. The evaluation is carried out on the basis of national and EU legislation and European guidelines.
The procedure concludes with a decision by the President of the Registration Authority to authorise the marketing of a veterinary medicinal product that is safe, effective and of the correct quality.
In order to obtain an authorisation to make a biocidal product available on the market and to use it, appropriate documentation must be submitted to the Registration Office. This includes, inter alia: the application for authorisation to market the biocidal product, the content of the labelling on the packaging, the safety data sheet and reports on the effectiveness of the biocidal product against specific pathogens carried out in accordance with the product’s use and approved European standards. The staff of the Registration Office assess the documentation accompanying the application for the authorisation of biocidal products, including the assessment of the labelling of the packaging and the efficacy of the biocidal product, as well as the assessment of the physicochemical, toxicological and ecotoxicological documentation. Decisions on obtaining an authorisation to market a biocidal product are issued by the President of the Registration Office.
