Article 243. The use of medicines for advanced therapy The Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. Medicines of advanced therapy are divided into the method of production and application:
1) produced industrially (routine method) in pharmaceutical production conditions according to the serial principle;
2) manufactured for individual use using autologous biological materials of the patient or his donor, selected directly for him.
2. The procedure for admission to the use, application and monitoring of the effectiveness and safety of the use of advanced therapy medicines is determined by the authorized body.
3. Medicines of advanced therapy are subject to clinical trials in accordance with the procedure established in Article 238 of this Code.
4. Medicines of advanced therapy produced in industrial conditions, in respect of which positive results of clinical trials have been obtained, for admission to the medical services market are subject to state registration in accordance with the procedure for State registration of a medicinal product or medical device established by Article 23 of this Code.
5. Medicines of advanced therapy produced for individual use, in respect of which positive results of clinical trials have been obtained, are allowed to enter the medical services market on the basis of the conclusion of an expert organization in the field of circulation of medicines and medical devices without a state registration procedure.
6. In exceptional cases, advanced therapeutics manufactured for individual use are used without conducting clinical trials as part of an exception to the standard procedure for the admission of a medicinal product to the market, provided:
1) the presence of a positive conclusion of the local Bioethics Commission;
2) there are scientific grounds to expect that the use of an advanced therapy drug will directly benefit the patient;
3) obtaining the informed consent of the patient or his legal representative for the use of an advanced therapy drug.
The doctor who prescribes an advanced therapy drug ensures compliance with these conditions and submits a report to the state expert organization in the field of circulation of medicines and medical devices and the Bioethics Commission based on the results of the use of an advanced therapy drug as part of an exception to the standard procedure for the admission of a drug to the market.
7. The procedure for the use of advanced therapy medicines as part of the exclusion from the standard procedure for the admission of a medicinal product to the market, as well as the list of medical organizations authorized to provide treatment under Hospital exemption, are determined by the authorized body.
President
Republic of Kazakhstan
© 2012. RSE na PHB "Institute of Legislation and Legal Information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan
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