Medicinal devices that have upon conformity assessment procedure obtained the CE marking in accordance with the regulations of the European Union and regulations of the Republic of Slovenia (Medicinal Devices Act, Official Gazette of the Republic of Slovenia, No. 98/09), which manage this field, have no limitations for placing on the market or putting into service in the territory of the European Union, which means that free movement applies.
At the request of the applicant, JAZMP may issue a declaration of free sale, which certifies that the medicinal device in question or a group of medicinal devices on the market is in accordance with the regulations of the European Union.
Certificate of free sale of a medicinal device may only be obtained by manufacturers of medicinal devices with a registered office in the Republic of Slovenia based on a decision issued on the entry in the register of medicinal devices.
Procedure of issuing a certificate of free sale
The applicant submits the application for obtaining a Certificate of free sale on the MedPri-MP-obr09 form and includes the following documentation:list of medicinal devices he wishes to obtain the Certificate of free sale for, in two copies. One (1) copy of the list should be signed by the authorised person of the applicant and one (1) copy on a clean blank sheet, which is without any markings of the company of the applicant and without a signature of the authorised person of the applicant, which will be an annex to the Certificate of free sale.
- List of medicinal devices must include at least the trade name of the medicinal device, in the form as it was notified for entry in the register of medicinal devices and as listed on the issued decision on the entry. The list may also include information that is relevant to the applicant (i.e. translations into a foreign language, catalogue number, and similar),
- Statement that information on potential withdrawal of the medical device from the market will be sent to JAZMP immediately after withdrawal.
The applicant may obtain the Certificate of free sale for those medicinal devices that are entered into the register of medicinal devices and hold a valid decision. Issuing a Certificate of free sale is bound to the decision on entry to the register of medicinal devices, which means that one Certificate of free sale cannot list medicinal devices that are bound to different applicable decisions on entry.
Costs of the procedure
Costs of the procedure for issuing the Certificate of free sale are defined in Article 10 of the Rules on fees in the field of medicinal devices (Official Gazette of the Republic of Slovenia (Uradni list RS), No. 37/10).
Fees for issuing a Certificate of free sale of a medicinal device are as follows:
- 20 points for one generic name,
- 30 points for a group of up to 10 generic names,
- 50 points for a group of 11 to 50 generic names,
- 100 points for a group of 51 to 100 generic names,
- 150 points for a group above 100 generic names,
The fees are specified in points. Point value is EUR 5. The amount of the fee is the point value multiplied by the number of points.
After reviewing the application, JAZMP sends a notice on the payment of a fee to the applicant with all information required for payment.