Documents for approval of clinical trials have to be submitted to the State
Pharmacology Centre at the Ministry of Health in Kiev or to the National Institute of Pharmacology in Chisinau,
Moldova. 
The Ukrainian institution meets once a month on the last Thursday and is the decision making body. The institution in Moldova meets every second Tuesday of each month. These Pharmacology Centres distribute the documents to the Central Ethics Committee and at least to two experts minmimum. The Ethics Committee and the experts provide the Pharmacology Centres with an expert opinion. The approval is granted only by the Pharmacology Centres. With the approval of the State Pharmacology Centre also the import- and export licences for trial material and -medication are available. In Chisinau Moldova the approval document must be legalised by signature of the Ministry of Health of Moldova. Verbal approval may be achieved within 2 - 4 days after the meeting of the Pharmacology Centres. In written approval will be in place within 10 working days. Submission of documents should be performed 6 – 8 weeks in Ukrain, 4 weeks in Moldava. A local Ethics Committee exists in Ukraine which is involved in the approval- and supervising process of a clinical trial but does not decide on approval.
The following documents have to be submitted:
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Protocol in Russian and English language
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CRF in English language (on demand of the State Pharmacology Centre)
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Investigator’s brochure in English language
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Certificates of analyses for trial medications
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GMP certificates for trial medications
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Authorisation letter for the investigator from the sponsor company and the IPR-EE clinical site
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Labels for Trial medication in Ukrainian/Modavian language
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Subject information and consent form in Russian/Moldavian and English language
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List of medication, trial material andbiological samples for import/export
All required translations are performed by team members of the IPR-EE clinical site. The IPR-EE clinical sites usually start selection of suitable
patients after submission of documents to the Pharmacology Centres to
have a pool of patients ready for screening by the time of getting approval. Approval process and regulations of authorities in Kiev and Chisinau follow
international standards and are accepted by registration authorities in the EU, US, Japan and Canada.