Идентификация

For the documentation provided through the Common European Submission Portal (CESP) – applications for all types of Marketing authorisation; applications for all types of Renewal; applications for all types of Variations and Notifications under Article 61(3) with the only exception - application for Transfer of Marketing authorisation:

• when the documentation is submitted through CESP, it is not necessary to submit it on CD/DVD;
• when the documents for which an original signature is required (cover letter, application form, QP declaration) are signed with a qualified electronic signature - their submission in paper is not necessary.

The submission of Product Information (Summary of Product Characteristics, Patient Leaflet, Labelling and mock-ups), in two copies printed on one side for all procedures that require it, remains mandatory.

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.

Albena Yordanova - head of Division “Manufacturing Licensing and Control”

Jenny Miteva - chief GMP inspector

Hristina Georgieva - chief GMP inspector

Petya Shatrovska - chief GMP inspector

Anna Mihaylova - chief GMP inspector

Yasmina Vodenicharska - chief GMP inspector

Nigyar Emin - chief GMP expert

Ivelina Kutsarova-Vasileva - chiefr GMP expert

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):

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...

In relation to the release of new EudraVigilance functionalities we would like to inform you that as of 22.11.2017 are valid the following electronic reporting rules:

• MAHs need to submit electronically to EVPM information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH concerned gained knowledge of the event.
• MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the MAH concerned gained knowledge of the event.
• MAHs need to use the EVWEB functionalities to gain access and download ICSR reports reported by NCA to the EVPM.

After 22.11.2017 there will be no changes to the reporting of SUSARs during clinical trials until the application of the Clinical Trial Regulation. Sponsors of clinical trials should follow the current SUSAR reporting principles set out in the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (2011/C 172/01).

More information on the following link:

EudraVigilance

Contact details:

Responsible person for EudraVigilance at the BDA:

Violeta Getova, MScPharm

Pharmacovigilance and Clinical Trials Department

+359 2 89034 91

This email address is being protected from spambots. You need JavaScript enabled to view it.

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)