Information for applicants/applicant representatives on using the prepayment mechanism for expert evaluation services of clinical trial materials when making changes to them (substantial amendments)

Initiation and execution of prepayment

• The procedure for prepayment for the services of expert evaluation of clinical trial materials of medicinal products is initiated by the Applicant, both when concluding a contract and within existing contractual relations between the State Expert Center of the Ministry of Health of Ukraine (hereinafter, the Center) and the Applicant.
• In accordance with subparagraph 2.4 (or 2.5) of the standard forms of the contract for expert evaluation of clinical trial materials (hereinafter, the Contract) (https://www.dec.gov.ua/materials/dogovori-na-provedennya-ekspertizi-materialiv-klinichnogo-viprobuvannya/), the total value of the Contract is determined as the sum of the cost of services specified in the Invoices-Specifications concluded under the terms of this Contract during its validity period.
• The Invoice-Specification defines the content, payment currency, scope, and cost of services for the expert evaluation of materials (https://www.dec.gov.ua/materials/vitrati-na-re-stracziyu/) and indicates the payer.
• To initiate the prepayment, the Applicant (or its authorized representative) submits to the “Service Center
  of the State Expert Center of the Ministry of Health of Ukraine” (hereinafter – the Service Center) a letter in the prescribed form (https://www.dec.gov.ua/wp-content/uploads/2021/prepaymentClinicalTrials/prepayment_CT_1.docx), in which it provides additional information on the expected quantity of clinical trial materials (procedures) planned for the period of validity of the contract.
• An employee of the “Service Center” accepts the Letter in accordance with the established procedure.
• If a contract needs to be concluded, the Applicant (or its representative), together with the Letter, submits to the “Service Center” a draft Contract with the package of documents required for its conclusion, together with a cover letter listing the documents provided and their number, prepared in accordance with the requirements of the legislation of Ukraine. This is followed by the procedure of verifying the conformity of data and validity of documents (for existing contracts) and/or approval (endorsement) of the Contract during its conclusion in accordance with the established procedure.
• After receiving the Letter with the mark, the Center's Accounting Department prepares, within 2 (two) working days, an invoice-specification for prepayment of the cost of services for the expert evaluation of clinical trial materials, which is signed by the chief accountant.
• An employee of the Accounting Department passes the invoices and specifications for prepayment of the cost of services to the Service Center for issue to the applicant on the day of the request.
• Notification of readiness of the invoice – specification for prepayment of the cost of services is displayed in the information system Visualization 2.0

Use of prepayment funds

• For the purpose of economical and rational use of working time, the Applicant may, if desired, use the funds of the advance payment for services to cover the costs of expert evaluation of subsequent procedures, including, if necessary, amendments to the clinical trial materials of medicinal products, within the expert evaluation of a single clinical trial protocol.
• The further procedure for expert evaluation of clinical trial materials takes place in accordance with the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, approved by MoH order of 23.09.2009 No. 690 (as amended).
• The invoice-specification for payment of the cost of services is issued to the Applicant or the Applicant's representative through the “Service Center” on the day the Applicant applies.
• After receiving the Invoice–Specification, the Applicant (or its authorized representative) submits to the “Service Center” a letter in the prescribed form (https://www.dec.gov.ua/wp-content/uploads/2021/prepaymentClinicalTrials/prepayment_CT_2.docx) for the transfer of funds from the prepayment invoice–specification to the invoice–specification for payment of the cost of services for expert evaluation of materials of a specific clinical trial or of amendments to clinical trial materials.
• Together with such a letter, the Applicant who has made a prepayment for the services may submit to the “Service Center”, for expert evaluation, clinical trial materials in accordance with the concluded Agreement.
• Clinical trial materials are received by an employee of the "Service Center" after confirmation of information about the Applicant's advance payment for the cost of services for the specialized evaluation of clinical trial materials in accordance with the established procedure.
• The provisions of section 2 of the Agreement apply without any exceptions to individual invoices-specifications.
• The accounting department monitors the receipt of funds or of a letter on offsetting and, as payment/offsetting occurs, verifies the correct transfer of data from the 1C: Accounting 8.3 database to the unified information and analytical system “PharmacoSolution” within two business days of the receipt of funds/offsetting.
• Upon request, the applicant may obtain from the Center’s Accounting Department a Reconciliation Statement of Mutual Settlements and reconcile the balance of funds if an advance payment was used.

Refund of prepayment funds

• If there are unused funds received as a prepayment, upon the Applicant's request by a letter in the prescribed form (https://www.dec.gov.ua/wp-content/uploads/2021/prepaymentClinicalTrials/prepayment_CT_3.docx), the funds are returned to the Applicant.»