03 Jul Bulgaria and the CESP system
Posted at 19:10h in Regulatory Affairs
Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. During the pilot phase CESP submissions were limited.
From 1 July 2020 BDA resumes accepting all types of applications and documents via CESP, except for clinical trials and transfers of MA. More information is available at CESP here. However, some nationally specific requirements for wet signature remain valid and are applicable also to submissions via CESP:
- – a signed paper copy of the eAF;
- – a signed paper copy of the Cover Letter;
- – Annex 5.4 Letter of authorisation for communication on behalf of the applicant/MAH (the signatures must be officially authenticated by a notary public or competent administrative official);
- – Annex 5.22 with original signature (QP declaration);
- – hard copies of national translations of Product Information.
Submission of these documents to the BDA may be delayed within a reasonable period of time when justified due to COVID-19.
Post updated: November 2021.