For the assessment of an annual safety report (ASR) under Commission Implementing Regulation (EU) 2022/20, of an active substance in clinical trials authorised in at least two Member States in EU (regardless of whether the clinical trials in question were authorised under Regulation (EU) No 536/2014 or initially under Directive 2001/20/EC and subsequently under Regulation (EU) No 536/2014) and Bulgaria is selected as the Safety assessing Member State, a fee is levied in the amount specified in Art. 13c of the Tariff for the fees collected under the Medicinal Products in Human Medicine Act - 1,800 (one thousand eight hundred) BGN.
In the "purpose of payment/remittance information" field in the proof of payment document, the type of procedure- assessment of an annual safety report and the number of the report - ASR ID should be indicated.
Bank Information:
IBAN: BG85 UNCR 7630 3100 1128 90
BIC: UNCRBGSF
BANK: UniCredit Bulbank AD
A Cover Letter (in English) should be submitted along with ASR submission in CTIS. The Cover Letter should contain the names of all MSs concerned for all ongoing CTs in EU/EEA within Directive as well as Clinical Trials Regulation, and for CTs under the CTD a list of all MSC with CTs under the CTD and the respective EudraCT numbers at time of ASR submission is required.
