The Bulgarian Drug Agency (BDA) announced on March 24, 2020 further measures related to the risk of COVID-19. The measures mainly concern the flow of communication with the agency. The primary aim is to encourage remote submissions and to reduce the number of visits to the administrative department and the reception desk.
CESP was already in the pilot phase with the BDA when it was announced that the agency will accept all submissions for marketing authorisations, renewals and variations via the CESP platform. However, the following documents must be provided with each submission:
– A signed paper copy of the eAF and 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 or Administrative official);
– Annex 5.22 with original signature (QP declaration).
Submission of these documents to the BDA may be delayed within a reasonable period of time. Additionally, the BDA still require hard copies of national translations of Product Information. The hard copies can be submitted and received at the agency using postal or courier services.
Apart from that, the agency also announced that they will accept documentation sent via e-mail for some of the other procedures, e.g. applications for CPPs (certificate of pharmaceutical product), import of medicinal products on a named patient basis, notifications related to placing medicinal products on the market, advertising notifications, as well as some other procedures.
The BDA published recommendations to the sponsors of clinical trials in view of the COVID-19 risk. The BDA refers to EMA’s Guidance on the Management of Clinical Trials during the COVID-19 pandemic.
PharmDedict closely monitors the situation with the COVID-19 pandemic, as well as the measures taken by the local administrative bodies. We continue to provide our services taking into account the current situation and operating under our business continuity plan.
Update 26/05/2020: CESP submission to the BDA restored to its normal limits.
Update 03/11/2020: The BDA announced that they will again accept documentation sent via e-mail for some of the procedures.
Update 18/11/2020: the requirement for one CD/DVD was removed.