Ministry of Health of Ukraine

13.02.2006 № 66

About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committee

(Registered with the Ministry of Justice on 10.03.2006 № 252/12126)

According to Articles 7 and 8 of the Law of Ukraine “On Medicines”, Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, as well as in order to achieve a harmonization with international rules for conduct of clinical trials of medicinal products

I ORDER:

1. To approve: 1.1. The Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials (attached). 1.2. Model Regulations of the Ethics Committee (attached). 2. To consider as void the Order of the Ministry of Health of Ukraine dated 01.11.2000 № 281 “About Approval of Instructions for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials of Clinical Trials and Model Regulations of the Ethics Committee”, registered with the Ministry of Justice of Ukraine on 17.11.2000 under № 830/5051 (amended). 3. To exclude Chapter 4 “Expert Evaluation of Materials of Pre-Clinical Study of Medicinal Product” of the Procedure for Conducting Pre-Clinical Study of Medicinal Products approved by the Order of the Ministry of Health of Ukraine dated 01.11.2001 № 441, registered with the Ministry of Justice of Ukraine on 20.11.01 under № 972/6163. 4. To establish that this order shall come into force starting 31.03.2006. 5. To exclude Chapter 4 “Procedure for submission of information about adverse reactions/events at clinical trials” of the Instructions for surveillance over adverse reactions/effects of medicinal products approved by the Order of the Ministry of Health of Ukraine dated 19.12.2000 № 347, registered with the Ministry of Justice of Ukraine on 26.12.2000 under № 947/5168 (amended). Therefore, Chapter 5 “Procedure for submission of information about adverse effect of medicinal product approved for medical use” of these Instructions shall be considered as Chapter 4. 6. That V.T. Chumak, Director of the State Pharmacological Center MoH Ukraine, submits the present order to the Ministry of Justice of Ukraine for state registration. 7. I hereby authorize V.F. Snisar, Deputy Minister of Health of Ukraine, to supervise execution of this order.

(Signature) Yu.V. Poliachenko Minister