The following entities are entered into the register of specialised stores who perform retail of medical devices:
- legal entities with a registered office in the Republic of Slovenia retailing medical devices in specialised stores,
- importers of medical devices involved in retail of medical devices with a registered office in the Republic of Slovenia.
Legal entities entered into the aforementioned register must meet the provisions of the medical Products Act (Official Gazette of the Republic of Slovenia, No. 98/09) and Rules on manufacturing and marketing medical devices (Official Gazette of the Republic of Slovenia, No. 37/10).
Retail sale of medical devices shall mean purchasing of medical devices and their further sale to individuals for personal use.
Import of medical devices for retail shall mean retail of medical devices from third countries into the territory of the European Union. Business Legal entities involved in wholesale marketing of medical devices may import only medical devices for which the manufacturer of medical devices from third countries have an authorised representative with a registered office in from the territory of the European Union.
PROCEDURE OF ENTRY, AMENDMENT AND DELETION FROM THE REGISTER OF SPECIALIZED STORES INVOLVED IN RETAIL OF MEDICAL PRODUCTS IN SPECIALISED STORES
Entry into the register is performed on the basis of an application of the applicant, which may be filed on the proposed application forms within 15 days of taking up the activity.
Entering an amendment into the register is performed on the basis of an application of the applicant, which may be filed on the proposed application forms within 15 days from the day of the amendment entering into force.
Deletion from the register is performed on the basis of a written request of the applicant, which must include the act of authority for operation of the legal entity or any other document which presents termination of operation of the appropriate activity or termination of operation of the legal
COSTS OF THE PROCEDURE
Costs of the procedure of entry, amendment or deletion from the register of specialized stores involved in retail of medical products in specialised stores of medical devices, in accordance with the Administrative Fees Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 106/2010 – official consolidated text, 14/15 – ZUUJFO, 84/15 – ZZeIP-J IN 32/16) amount to 4.50 EUR and must be transferred to the following account:
Invoice No.: 01100-1000315637, reference number: 11 27650-7111002 with the beneficiary of the payment: Administrative fee – national Ljubljana (mandatory!)
Receipt against payment must be included in the application as proof.
For notifying the entry, amendment of information or deletion from the aforementioned register, please complete the following form:
- Application for a certificate of registration in the register of activities involving medical devices
The certificate is issued at the request of the applicant within 15 days from receiving the claim and is free of charge.