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Announcements for companies

Announcements for companies

In connection with the Requests for Fee allocation, we would like to inform you that BDA ceases the reallocation of amounts not paid in accordance with the Fee Tariff collected under LMPHM.

According to the definition in § 1, item 5 of the Additional Provisions of the LMPHM, "valid documentation" is documentation which in its content and completeness meets the requirements set forth in the special law and by-laws. Applying the provisions of the Law, BDA will not accept a valid application, which does not contain a fee payment document stating the correct amount and reason for payment corresponding precisely to those specified in the Tariff. Failure to apply this payment document is grounds for terminating the procedure.

Any incorrect amounts under the Tariff, submitted after January 1, 2018, SHALL NOT BE allocated TO OTHER APPLICATIONS AND PROCEDURES. Any unduly paid fees may be refunded in accordance with Art. 4b of the State Fees Act after submitting a Request.

Announcements for companies

When requesting an administrative service for marketing authorization/registration, variations, renewals of MA, transfer of MAH, line-extension, changes in product information, parallel import, annual maintenance fees or recall of existing MAs, each application form should be accompanied by a separate payment order with the exact amount of the state fee for the relevant procedure, calculated according to the respective Tariffs for fees collected under the Act for medicinal products for human use.

For your convenience, you can use the calculator to estimate the fees of the following link:

Калкулатор на тарифите за разрешенията за употреба на лекарствени продукти

The payment order should contain the following information (described as reason for payment):

  1. NUMERICAL CODE OF THE PROCEDURE*
  2. TRADE NAME OF THE MEDICINAL PRODUCT, strength of THE ACTIVE SUBSTANCE, PHARMACEUTICAL FORM
  3. REGISTRATION NUMBER OF THE MEDICINAL PRODUCT**