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):

1. NUMERICAL CODE OF THE PROCEDURE*
2. TRADE NAME OF THE MEDICINAL PRODUCT, strength of THE ACTIVE SUBSTANCE, PHARMACEUTICAL FORM
3. REGISTRATION NUMBER OF THE MEDICINAL PRODUCT**

Read more: TO ALL APPLICANTS, MARKETING AUTHORIZATION HOLDERS AND THEIR LOCAL...

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.

Fees for marketing authorization

Fees for MA via national procedure

Fees for MA via Mutual recognition procedure

Fees fo MA via DCP procedure

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Template of Declaration of conformity contents (There are no translations available)

Important links about medical device regulation:

• European Commission - Medical Device Sector:

http://ec.europa.eu/enterprise/medical_devices/index_en.htm

• Guidelines relating to Medical Device Directives:

http://ec.europa.eu/consumers/sectors/medical_devices/documents/guidelines/index_en.htm

• Global Harmonization in Medical Device Regulation. Guidelines:

http://www.ghtf.org/whatsnew.html

• Medical Device Nomenclature Systems:

http://www.ecri.org/Products/Pages/UMDNS.aspx

http://www.gmdnagency.com/?id=nom

(There are no translations available)

Guidelines on Medical Devices Vigilance System (There are no translations available)

Template for a Field Safety Notice

Template for National Competent Authority Report (There are no translations available)

Report Form Manufacturer's Incident Report (initial/final incident report)

Report Form Field Safety Corrective Action

Incidents/ potential incidents Report Form for medical devices, in accordance with art.104 of MDL

Notes on completing the Clinical Investigation Notification / Application Form

Application form for Statement of Ethics Committee for Clinical Investigation of Medical Device

Application form to Ethics Committee for Significant Changes in Clinical Investigation of Medical Device and Documentation on art. 48 (1) of MDL

Notification form for Medical Device Clinical Investigation (art. 45 (2) of MDL)

Clinical Investigation Application form art. 45 (1) of MDL

Application form to BDA for significant changes in clinical Investigation and documentation on art. 50 (1) of MDL

Report form for incident/near incident in conduct of clinical investigation of medical device

SAE reporting form (MEDDEV 2.7/3)

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Medical Devices categories

Application for the registration of manufacturers and In Vitro Diagnostic Medical Devices placed on the market and/or putting into service in Bulgaria, in accordance with Art.28(1) and (3) of MDL / IVDMD Directive, Art.10

Application for the registration of manufacturers and medical devices, placed on the Bulgarian market and/or putting into service, in accordance with art. 27 (1) of MDL

Form to submit an information for medical devices putting into service in Bulgaria, in accordance with art. 30 of MDL

Form for the notification of In Vitro Diagnostic Medical Devices IVDMD Directive, Art.10.6

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)