Schedule for ex offcio check under Art 43

EX OFFICIO CHECK SCHEDULE ACCORDING TO ART. 43 OF THE ORDINANCE ON THE TERMS, RULES AND PROCEDURE FOR REGULATION AND REGISTRATION OF PRICES FOR MEDICINAL PRODUCTS

Schedule for checking the prices of medicinal products in accordance with Art. 43 of the ORDINANCE ON THE TERMS, RULES AND PROCEDURE FOR REGULATION AND REGISTRATION OF PRICES FOR MEDICINAL PRODUCTS (SG, No. 26 of 2019, in force from 01.04.2019, amended and supplemented by SG No. 28 of 6 April 2021)

NCPR carries out administrative and penal activity in accordance with Art. 289, paragraph 2 of the Medicinal Products in Human Medicine Act. According to the requirement of Art. 43, para. 1, 2, 3, 4 and 5 of the Ordinance, the Marketing Authorization Holder or his authorized representative shall follow every 6/24 months from the date of approval of the last price to submit to the National Council on Prices and Reimbursement of Medicinal Products a declaration of no change in the prices specified in the declaration-reference under Art. 33, para. 2, on the basis of which the price of a medicinal product included in the PDL was approved or an application to change an approved price. A Marketing Authorization Holder who fails to fulfill an obligation defined by the Ordinance under Art. 261a, para. 5 of the Medicinal Products in Human Medicine Act, shall be punished with a pecuniary sanction of BGN 5,000 to BGN 10,000, and in the event of repeated commission of the same violation - with a pecuniary sanction of BGN 10,000 to 20,000.

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Schedule 24 monthly checks

Schedule 6 monthly checks