ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of May 23, 2007 No. 413

About approval of Rules of exception from under control of the medicines containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods, and the list of the specified medicines

According to the Law of the Republic of Kazakhstan of July 10, 1998 "About drugs, psychotropic substances, precursors and measures of counteraction to their illicit trafficking and abuse of them" the Government of the Republic of Kazakhstan DECIDES:

1. Approve enclosed:

1) Rules of exception from under control of the medicines containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods;

2) the list of the medicines which are containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods, and not subject to control in the Republic of Kazakhstan.

2. This resolution becomes effective from the date of the first official publication.

Approved by the Order of the Government of the Republic of Kazakhstan of May 23, 2007 No. 413

Rules of exception from under control of the medicines containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods

1. General provisions

1. These rules of exception from under control of the medicines containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods (dalee-Pravila) are developed according to the Law of the Republic of Kazakhstan of July 10, 1998 "About drugs, psychotropic substances, precursors and measures of counteraction to their illicit trafficking and abuse of them".

2. Rules and the list of the medicines which are containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods, and not subject to control in the Republic of Kazakhstan (further - the list), affirm the Government of the Republic of Kazakhstan according to the offer of state body in the field of health care (further - state body).

2. Procedure for exception from under control of medicines

3. These Rules regulate procedure for exception from under control of the medicines containing small amount of drugs, psychotropic substances and precursors from which the specified means and substances cannot be taken by readily available methods.

4. The exception from under control of the medicines containing drugs, psychotropic substances and precursors, constituting insignificant danger in case of abuse of them and from which the specified means and substances cannot be taken by readily available methods (further - medicines) is considered in case of state registration of medicines in the Republic of Kazakhstan.

5. The state body according to the procedure, established by the legislation, adopts the statement for state registration of medicine from the applicant (producer of medicine, the authorized representative or representation in the Republic of Kazakhstan).

6. After receipt of the statement carries out the analysis of presence in the market of analogs of the medicine declared on state registration.

7. Following the results of the carried-out analysis the conclusion about feasibility of carrying out expert works is constituted.

8. The conclusion is transferred to the organization determined by authorized body (further - the organization) for carrying out expert works, in time, not exceeding 15 days.

9. The organization at stage of specialized examination, following the results of the expert opinion on medicine in the form approved by state body constitutes the conclusion about reference of medicine to the list.

10. The conclusion about reference of medicine to the list is submitted in state body with reasons for the made decision.

11. Reference of medicine to the list is made if the drugs, psychotropic substances and precursors containing in medicine cannot be extracted by readily available method and their content does not exceed the quantities specified in appendix to these rules.

12. The maximum content of drugs, psychotropic substances and precursors in the medicine which is subject to exception from under control shall not exceed amounts of the active ingredient specified in appendix to these rules.

13. The state body based on the conclusion of the organization and appendix to these rules makes the decision on exception from under control of medicines which further turnover is not subject to control in the Republic of Kazakhstan.

14. The medicines excluded from under control are subject to inclusion in the list.

15. The state body after state registration, in the procedure established by the legislation, brings the corresponding amendments approved with state body in the sphere of drug trafficking, psychotropic substances and precursors in the list.

Appendix

to Rules

The list of drugs, psychotropic substances and precursors with their most admissible content in medicine

Dextromethorphan: - for not dosed dosage forms (syrups, drops and others) % 0,2 (2 mg/ml) per unit of dose; 250 mg on 1 packaging:

deksiropropoksifen:

for the dosed dosage forms of 50 mg per unit of dose; 500 mg on 1 packaging;

for not dosed dosage forms (syrups, drops and others) % 0,5 (5 mg/ml) per unit of dose; 250 mg on 1 packaging:

codeine (or codeine phosphate in terms of codeine the basis):

for the dosed dosage forms of 10 mg per unit of dose; 200 mg on 1 packaging;

for not dosed dosage forms (syrups, drops and others) per unit of % 0,5 dose (5 mg/ml); on 1 packaging of 200 mg;

phenobarbital:

for the dosed dosage forms of 20 mg per unit of dose; 750 mg on 1 packaging;

for not dosed dosage forms (syrups, drops and others) 2% (20 mg/ml) per unit of dose; 1 000 mg on 1 packaging:

ephedrine hydrochloride:

for the dosed dosage forms of 20 mg per unit of dose; 200 mg on 1 packaging:

for not dosed dosage forms (syrups, drops and others) % 0,2 (2 mg/ml) per unit of dose; 200 mg on 1 packaging:

efedra grass (in terms of ephedrine the basis):

for the dosed dosage forms of 20 mg per unit of dose; 200 mg on 1 packaging;

for not dosed dosage forms (syrups, drops and others) % 0,2 (2 mg/ml) per unit of dose; 200 mg on 1 packaging;

pseudoephedrine hydrochloride:

for the dosed dosage forms of 15 mg per unit of dose; 150 mg on 1 packaging;

for not dosed dosage forms (syrups, drops and others) % 0,6 (6 mg/ml) per unit of dose; 600 mg on 1 packaging;

folkodin:

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