In February 2018, the Bulgarian Drug Agency (BDA) announced new requirements for fee payments which are important for all applicants, marketing authorisation holders and their representatives.

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.

As far as the requests for fee allocation are concerned, 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.

For an annual maintenance fee, where in one payment order several products are included the payment order shall be accompanied by a list containing the names of the medicinal products, the strength of active substances per unit dose and the pharmaceutical forms as well as the registration numbers of the medicinal products for which the fee is payable.

For a grouped variation, the payment order shall be accompanied by a list containing the names of the medicinal products with the strength of active substances per unit dose and the pharmaceutical forms as well as the registration numbers of the medicinal products for which the fee is payable.

For further information, please contact Jane Smith at Grove Group Pharmaservices janesmith@groveonline.com or visit our website www.groveonline.com