Wholesale trade of medical devices is a multi-layered and complex process, occupying an increasingly important place in modern markets. It is covered by a number of regulatory regimes that must be carefully adhered to. In order for a person to be able to wholesale medical devices at all, they must first obtain the appropriate permit.
The subject of this article is precisely the conditions and procedures for issuing a permit for wholesale trade in medical devices on the territory of the Republic of Bulgaria. The issues for persons eligible for a wholesale trade permit are briefly touched upon below; the competent authority, as well as the procedure for issuing the relevant permit.
Regulation
At national level, the matter concerning obtaining a marketing permit for wholesale of medical devices is regulated in Medical Devices Act (MDA), as well as the regulations on its implementation. The relevant acts of European legislation also apply, among which of particular importance are Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices and Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of some of its provisions.
Who could obtain а Marketing Permit for wholesale of medical devices?
Permit for wholesale of medical devices on the territory of the Republic of Bulgaria can be issued to both, individuals and trading companies.
Who issues the permits for wholesale of medical devices in the Republic of Bulgaria?
The competent authority issuing a permit for wholesale trade of medical devices in the Republic of Bulgaria is the Bulgarian Drug Agency (BDA).
How does the procedure for issuing a permit for wholesale trade of medical devices unfold?
The authorisation procedure starts with the submission of an application form in the Bulgarian Drug Agency. The application shall be made by the person wishing to obtain the relevant permit or his authorised representative.
The application shall be accompanied by the following documents:
- Information about the person that will be wholesale trading. This information is to be completed in a separate questionnaire – in appendix to the application.
- A list outlining the categories of medical devices. The list itself shall be in a form annexed to the application itself, which shall be completed by the applicant;
- Declaration that they own or have means of transport ensuring their proper storage during distribution and transportation
- Document for paid fee.
When they have premises for the storage of medical devices on the territory of the Republic of Bulgaria, the persons shall indicate their address in the application. In this case, the following documents must also be attached to the application:
- A declaration that the premises meet the conditions for the storage of medical devices, depending on their specifics and the manufacturer’s instructions set out in the instructions for use;
- Information 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, as well as a copy of the contract on the basis of which his legal relationship with the applicant arose
Fee
For the issue of a permit for wholesale trade of medical devices, a fee is payable, amounting to and determined according to the fare for the fees collected under the Medical Devices Act. In this particular case, the fee due amounts to BGN 5,000.
Term for pronouncement
Within 30 days from the date of submission of the application, the Executive Director of the Bulgarian Drug Agency will issue the permit, or in case he considers that the requirements of the Commercial law on medical devices are not met – make a reasoned refusal.
Validity of the issued permit
In the event that a permit is issued for the wholesale of medical devices, it shall be perpetual, i.e., its periodic renewal is not necessary.
In the event of changes concerning the opening of a new warehouse for storage and trade of medical devices on the territory of the Republic of Bulgaria or change of address of the premises for storage and trade of medical devices on the territory of the Republic of Bulgaria, then the merchant should submit an application for amendment of the already issued permit.
The article above is for information purposes only. It is not (binding) legal advice. For a thorough understanding of the subjects covered and prior to acting on any issue discussed, we kindly recommend Readers to consult attorneys at Ilieva, Voutcheva & Co. Law Firm.
