IMPORTANT!

BDA additional requirements and fees for MRP/DCP/NP

Since January 1^st 2010, for all types of applications, concerning procedures for marketing authorization of medicinal products- national, decentralized or mutual recognition procedure- it is mandatory that they should be submitted electronically- in eCTD or NeeS format.

For further information, please use the following links:

http://esubmission.emea.europa.eu/eurs/index.html

http://estri.ich.org/

http://www.ich.org/MediaServer.jser?@_ID=554&@_MODE=GLB

The documentation should be submitted on CD or DVD (2 copies). No paper copies are required, except for the below-mentioned documents, which should be with an original signature:

1. Cover letter;
2. Application Form;

Person/company, authorized for communication on behalf of the applicant and settled down in Bulgaria, should be specified in the Application form (for mutual recognition and decentralized procedures- a contact person/company, settled down in Bulgaria, is highly recommended for the national phase of the procedures).

For national procedures, the Application form should be in Bulgarian language; for mutual recognition and decentralized procedures- in Bulgarian or in English language.

1. 3.     Annex 5.4- Letter of authorisation for communication on behalf of the applicant/MAH;
2. 4.     Declaration for identity of the dossier, submitted to the RMS and all CMSs (if not specified in the Cover letter);
3. 5.     Annex 5.22- Declaration/s from the Qualified Person/s, regarding compliance of the active substance/s with the detailed guidelines on GMP as required.

Regulation (EC) № 1234/2008 requirements will be applied for purely national marketing authorizations after implementing them into national Medicinal Products in Human Medicine Act.

The Bulgarian Drug Agency would like to inform all Marketing Authorization Holders, that when submitting grouped variations of Marketing Authorizations according to Regulation (EC) № 1234/2008, the relevant fees, as appointed in the Information for fees, should be paid for every single variation in the composition of the grouped variation.

For your convenience, please find below the Information for the fees, regarding variations:

Address for advice on fees

ACCOUNTANT: Violeta Georgieva

Tel.: +359/ 2 /8903422

e-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Bank data for Bulgarian Drug Agency

8, Damyan Gruev Str., 1303,  Sofia, Bulgaria

Tel: +359 2 8903422

Fax: +359/2/8903434

Bank: Unicredit Bulbank, Branch KALOYAN

IBAN: BG85 UNCR 7630 3100 1128 90

BIC: UNCRBGSF

 Identification number: 121203554

Information for fees for marketing authorization via Mutual recognition procedure (MRP)

Information for fees for marketing authorization via National procedure (NP)