BORA SESPA

BORA SESPA automatically submits the daily data to the Bulgarian Drug Agency (BDA). The module is part of BORA Business Suite and was built to the requirements of Ordinance No. 4 of 31 May 2019 on the Specialised Electronic System for Tracking and Analysis of Medicinal Products (SESPA).

BORA SESPA

The software covers every individual transaction that wholesalers and marketing authorisation holders must report. A complex regulatory task becomes a fast and secure operation that runs in the background of your ERP system.

What is reported to SESPA

BORA SESPA takes the data straight from the warehouse and trade operations. For medicines on the Positive Drug List, the module creates and sends automatically:

  • deliveries: all quantities delivered and received into the wholesaler’s warehouses;
  • sales: the quantities from the Positive Drug List dispensed, sold and handed over to third parties;
  • daily stock: the physical quantities in the warehouse by product, code and batch.

Benefits for pharmaceutical companies

  • Nobody fills in web forms or uploads files to the BDA portal. The system creates and sends the reports by itself.
  • Transactions are reported every day and accurately, which protects you from fines for missed or late reports.
  • The module reports at the lowest level, every single transaction. Every box of medicine is traced from receipt to dispatch.
  • The module is part of BORA Business Suite, and no external programs are needed. Trade and warehouse documents trigger the preparation of the SESPA data by themselves.

Who must use BORA SESPA?

The module is needed by:

  • wholesalers of medicinal products (distributors) that trade on the domestic market, import or make intra-Community acquisitions;
  • marketing authorisation holders (manufacturers) and their official representatives in Bulgaria.

Frequently asked questions about BORA SESPA

How exactly is data transferred from BORA BS to the state SESPA system?

Electronically, through the BDA’s secure programming interface (API). BORA SESPA connects to the state server over an encrypted connection and authenticates with your company’s digital certificates. Sending can run automatically on a schedule at the end of each working day.

How does the system know which medicinal products in our warehouse must be reported?

The BORA Business Suite catalogue has a special flag and a field for the product’s identification code in the SESPA/Positive Drug List register. For a new item or during synchronisation, the software connects to the BDA’s official list. For every warehouse operation the system reports only the products the law requires.

Is there a check for errors before the data goes to the BDA?

Yes. Before sending, the module checks that the required data is filled in on the trade documents: batch number, expiry date, quantity, counterparty code. If something is wrong, the operator gets an alert to fix it. Wrong or incomplete information does not reach the state system.

What happens in BORA BS if the BDA changes the technical requirements for submitting the files?

BORA Solutions follows regulatory and technical changes because it works with clients in regulated sectors. As soon as the BDA updates its interface, our team updates BORA SESPA, and clients receive the new version as part of their support.