For citizens

For companies

For medical specialists

Information for companies

In connection with the Requests for Fee allocation, we would like to inform you that BDA ceases the reallocation of amounts not paid in accordance with the Fee Tariff collected under LMPHM.

According to the definition in § 1, item 5 of the Additional Provisions of the LMPHM, "valid documentation" is documentation which in its content and completeness meets the requirements set forth in the special law and by-laws. Applying the provisions of the Law, BDA will not accept a valid application, which does not contain a fee payment document stating the correct amount and reason for payment corresponding precisely to those specified in the Tariff. Failure to apply this payment document is grounds for terminating the procedure.

Any incorrect amounts under the Tariff, submitted after January 1, 2018, SHALL NOT BE allocated TO OTHER APPLICATIONS AND PROCEDURES. Any unduly paid fees may be refunded in accordance with Art. 4b of the State Fees Act after submitting a Request.

When requesting an administrative service for marketing authorization/registration, variations, renewals of MA, transfer of MAH, line-extension, changes in product information, parallel import, annual maintenance fees or recall of existing MAs, each application form should be accompanied by a separate payment order with the exact amount of the state fee for the relevant procedure, calculated according to the respective Tariffs for fees collected under the Act for medicinal products for human use.

For your convenience, you can use the calculator to estimate the fees of the following link:

Калкулатор на тарифите за разрешенията за употреба на лекарствени продукти

The payment order should contain the following information (described as reason for payment):


Request for reviewing of the possibility for initiating a decentralized (DCP)/ mutual recognition (MRP) procedure for a marketing authorization of a medicinal product with the Republic of Bulgaria as a reference member state (RMS).

BDA accepts requests for initiation of a DCP or MRP procedure for a marketing authorization of a medicinal product with the Republic of Bulgaria as a RMS on the e-mail address: This email address is being protected from spambots. You need JavaScript enabled to view it.

The request for reviewing the possibility of initiation of a DCP/MRP procedure has to be submitted with form "Request for RMS in a Decentralised Procedure, medicinal products for human use" (slot request form), available on the CMDh website.

All of the required information in the form is to be filled in.

The request has to be submitted no later than 3 months from the planned initiation date for a DCP/MRP procedure.

BDA will assess each request received in accordance with the planned business processes, available human resources and established internal criteria, and will be able to accept no more than 4 procedures as a RMS in one calendar year.

Single, central platform now mandatory for all periodic safety update reports

PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU

As of 13 June 2016, all periodic safety update reports (PSURs) for human medicines authorised in the European Union (EU) must be submitted to the PSUR repository, which has been developed by the European Medicines Agency (EMA) in close collaboration with EU Member States and the industry.

More information on this is included in the hyperlink below:

Single, central platform now mandatory for all periodic safety update reports (10/06/2016)

Information for companies, Medical devices

Page 1 of 3