A wholesale trade medical devices permit on the territory of the Republic of Bulgaria is carried out on the basis of Art. 78a of the Medical Devices Act.
The procedure is regulated in Art. 77 et seq. and Art. 78a of the Law on medical devices /LOMD/. It is issued by the Medicines Executive Agency.
An applicant can be any natural or legal person registered under the Commercial Law or under the legislation of another member state or of a state party to the Agreement on the European Economic Area /AEEA/, or of the Swiss Confederation.
The state fee is BGN 5,000 and is paid to the following account of the Drug Enforcement Agency:
Bank: Unicredit Bulbank, Kaloyan Branch, IBAN: BG85 UNCR 7630 3100 1128 90, BIC: UNCRBGSF. In the basis of payment, indicate: “Fee for issuing a permit for wholesale trade in medical devices”. A copy of this payment is certified in the accounting of IAL and submitted, together with the registration documents themselves.
The required documents are:
➧ Application according to the IAL model
➧ Uniform identification code from TR of the Registration Agency for the company
➧ List of medical devices on paper and magnetic
➧ Declaration under the Medical Devices Act
➧ Data on the name, permanent address and correspondence address of the person designated as the manager of the premises for storage and trade of medical devices
➧ Term for issuing a permit for wholesale trade in medical devices – up to 30 days from the receipt of valid documentation.
Wholesalers (TE) notify IAL within 7 days after making a change to:
➧ the legal status, the seat and/or address of management and/or
➧ upon change of the responsible person, and/or
➧ when changing the list of types of medical devices with which they trade;
The documentation related to the change is attached to the notification.
The Executive Director of IAL issues a change permit within 14 days from the date of submission of the documentation.
➧ affixed “CE” marking in accordance with the requirements of the CE;
➧ Lot/serial number affixed to packages where applicable;
➧ Applied identification number of the notified body, when the procedures defined in the regulations under Art. 18 of the MMI require its application;
➧ Name and address of management of the manufacturer and/or the authorized representative and the importer applied;
➧ Instructions for use, with the exception of products for which this is not provided for by law;
➧ Persons are obliged to maintain the premises for the storage of medical devices, when they have them, in accordance with the storage requirements for the relevant type of device, determined by the manufacturer.
Wholesalers of medical devices provide and maintain a documented system for tracking the safety of medical devices placed on the market and for blocking and withdrawing from the market medical devices that have shown non–compliance with safety requirements in the sense of Chapter Seven of the Medical Devices Act;
The batch certificates of the medical devices are kept with the documentation for a period of 5 years and are provided at the request of the officials;
Persons are obliged to store expired medical devices, blocked and/or withdrawn medical devices in a designated place with a permanent signal designation until they are provided to the manufacturer or until they are destroyed.