Bulgaria have joined the CESP system

Bulgaria have joined the CESP system

Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. However, during the pilot phase CESP submissions will be limited. It will be applicable only to the new marketing authorisation applications via DCP/MRP. Purely national MA procedures and variations are excluded from CESP scope for the time being. In addition, some nationally specific requirements remain valid and 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;
  • – one CD/DVD.