BDA: new requirements for the “proof of payment” document
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09 Feb BDA: new requirements for the “proof of payment” document

Posted at 18:34h in Regulatory Affairs by

Starting in February 2018, the Bulgarian Drug Agency (BDA) applies additional requirements to the applicants when presenting proof of payment. These regard the fees paid for the administrative procedures managed by the BDA: marketing authorisations (MA) or registrations, variations, renewals of MA, transfer of MA, line-extensions, notification for changes in product information, parallel import, annual maintenance fees or withdrawals of existing MAs.

The payment order should now contain the following information included in the payment reference:
– numerical code of the procedure;
– the brand name of the medicinal product, the strength of the active substance and the pharmaceutical form;
– BDA registration number of the concerned medicinal product or the international procedure number in case of mutual recognition procedures (MRPs) or decentralised procedures (DCPs).

The codes, as well as instructions, are available in English on the website of the BDA here. The bank account details are published here.

Currently, the BDA have discontinued their practice to issue proforma invoices in advance of the payments. Foreign applicants (MAHs) will have to consider the following issues and possible pitfalls:
– precise calculation of the applicable fee in BGN on a case by case basis;
– if it is not possible to have the bank transfer ordered in BGN, then the currency conversion will be done by the BDA servicing bank and their exchange rates have to be considered in order to avoid underpayments due to the currency conversion;
– the applicants have to make sure that the BDA receives the fee amount net –  excluding any bank service charges.

In a separate post the BDA announce that in case of fees wrongly paid by the applicant, the BDA will no longer allocate any overpaid amounts to other procedures of the same applicant. Any unduly paid fees may only be refunded after submitting a written request which is a time-consuming process.

That makes the fees management process very important for the applicants. Failure to provide a correct payment document gives grounds for terminating the procedure. Local fees management is part of the services provided by PharmDedict.