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):
- NUMERICAL CODE OF THE PROCEDURE*
- TRADE NAME OF THE MEDICINAL PRODUCT, strength of THE ACTIVE SUBSTANCE, PHARMACEUTICAL FORM
- REGISTRATION NUMBER OF THE MEDICINAL PRODUCT**
*NUMERICALCODES OF PROCEDURE ARE AS FOLLOWS:
0002 (Marketing authorization (MA)
0005 (Line-extension)
0003 (Marketing authorization of a homeopathic MP)
0004 (Registration of a homeopathic/traditional herbal MP)
0007 (Transfer of MAH)
0008 (Notification for change to the labelling or package inserts)
0009 (Renewal of MA)
0010 (MA for parallel import)
0011 (Withdrawal/Recall of existing MA/Registration certificate)
0013 (Fee for annual maintenance of MA. The number of MPs for which the fee is to be paid must also be indicated) ***
*** 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.
0041 (Renewal of a homeopathic/traditional herbal MP)
0042 (Variation type IA, including grouped variation type IA) ****
0043 (Variation type IB, including grouped variation type IB) ****
0044 (Variation type II, including grouped variation type II) ****
0045 (Групирана промяна от различен тип - за един лекарствен продукт)****
**** 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.
* Only NUMERICAL CODE is to be noted in the payment order, and the type of procedure is not to be written down in words.
** The registration number of the medicinal product IS NOT to be written in the following cases:
- 1. For a national procedure for marketing authorization/registration procedure;
- 2. In case of DCP/MRP marketing authorisation/registration procedures, the international procedure number is indicated instead of the registration number (e.g. XX/H/nnnn/01/DC).
