• Increase font size
  • Default font size
  • Decrease font size
Information for citizens
Information for medical specialists
Information for companies
Home Imoprtant! Important!
Important!

From 01.01.2010 for all types of procedures for marketing authorization - national, by mutual recognition, decentralized - it is obligatory the applicants to submit the documentation in electronic format - eCTD or NeeS.

Additional information for the requirements to the electronic documentation can be found in Guidance for electronic submission of documents eCTD and NEES ver. 04, 31.03.2009 on the web site of BDA.

The documentation is submitted on electronic storage devices (CD or DVD), with the exception of the following documents with original signature, which are submitted on paper and are considered as a part of the eCTD documentation:

1. Covering letter.

2. Application with authentic signature, in which is specified the natural or legal person, settled in the territory of the Republic of Bulgaria, whom to present the applicant/MAH (marketing authorization holder) in national procedures and in the national phases of mutual recognition and decentralized procedures ("representative") with contact data (name, address, telephone, e-mail). The application for the national procedure is in bulgarian language, and for the mutual recognition procedure and the decentralized procedure - in bulgarian or english language.

3. Declarations and powers of attorney with authentic signature including:

3.1. Appendix 5.4. Letter authorizing the representative to represent the applicant/MAH

3.2. Identity declaration of the file (if not specified in the covering letter)

3.3. Declaration from Appendix 5.22 to the application.

3.4. Patent declaration and data exclusivity.

 
Top