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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of May 13, 2013 No. 333

About approval of the Procedure for acquisition, transportation, storage, leave, use and destruction of drugs, psychotropic substances and precursors in health care institutions

(as amended on 08-08-2016)

According to part three of article 21 of the Law of Ukraine "About drugs, psychotropic substances and precursors" the Cabinet of Ministers of Ukraine decides:

1. Approve the Procedure for acquisition, transportation, storage, leave, use and destruction of drugs, psychotropic substances and precursors in health care institutions which is applied.

2. To the Ministry of Health to bring in three-months time own regulatory legal acts into accord with this resolution.

Prime Minister of Ukraine

N. Azarov

Approved by the Resolution of the Cabinet of Ministers of Ukraine of May 13, 2013, No. 333

Procedure for acquisition, transportation, storage, leave, use and destruction of drugs, psychotropic substances and precursors in health care institutions

General questions

1. This Procedure determines the implementation mechanism health care institutions irrespective of their subordination and pattern of ownership (health care daleezavedeniye) of the activities connected with production, storage, transportation, acquisition, realization (leave), import to the territory of Ukraine, export from the territory of Ukraine, en route through the territory of Ukraine, use, destruction of drugs, the psychotropic substances included in tables II and III of the list of drugs, psychotropic substances and precursors approved by the resolution of the Cabinet of Ministers of Ukraine of May 6, 2000 No. 770 (The Official Bulletin of Ukraine, 2000 No. 19, of the Art. 789) (further - the list) and the precursors included in the table IV of the list, registered in accordance with the established procedure as medicine (further medicines of drugs, psychotropic substances and precursors) and also features of activities of treatment-and-prophylactic institutions during implementation of the specified activities.

2. Action of this Procedure does not extend on:

health care institutions in case of implementation of activities by them in the sphere of the address of the medicines containing small amount of drugs, the psychotropic substances included in tables II and III of the list, and (or) the precursors included in the table IV of the list therefore there is no risk of abuse of them or it is insignificant and from which the specified means or substance cannot be withdrawn by readily available methods in quantity in case of which abuse is possible;

bureau of forensic medical examination, control and analytical laboratories, laboratories for carrying out the analysis of quality of medicines, blood transfusion stations, the centers of procurement and conversion of plasma, the centers of service of blood, sanitary and preventive institutions and diagnostic laboratories in case of implementation of the activities connected with use of drugs, psychotropic substances and precursors by them for the purpose of conducting judicial examination, the laboratory analysis, control of quality of medicines, and in other cases which are not providing use of drugs, psychotropic substances and precursors for treatment and rehabilitation.

3. Institutions of health care perform the activities connected with production, storage, transportation, acquisition, realization (leave), import to the territory of Ukraine, export from the territory of Ukraine, en route through the territory of Ukraine, use, destruction of drugs, psychotropic substances and precursors (further - the address of drugs, psychotropic substances and precursors), in the presence at them is licenses for implementation of the corresponding types of activity according to the Law of Ukraine "About drugs, psychotropic substances and precursors" and the Procedure of the activities connected with the address of drugs, psychotropic substances and precursors, and control of their address approved by the resolution of the Cabinet of Ministers of Ukraine of June 3 in 2009 No. 589 (The Official Bulletin of Ukraine, 2009 No. 44, the Art. 1477), and also other regulatory legal acts.

4. For ensuring storage, transportation, acquisition, use, destruction and leave in institutions of health care of medicines of drugs, psychotropic substances and precursors, the head of institution of health care designates responsible persons from number of persons employed of such institution to whom functions on production, storage, transportation, acquisition, acceptance, realization (leave), use, accounting, destruction, and also on delivery of medicines of drugs, psychotropic substances and precursors to the patient to whom medical care is provided in stationary conditions (further - the responsible person) are assigned.

5. The list of the responsible persons allowed to work with medicines of drugs, psychotropic substances and precursors in health care institution, their job responsibilities, procedure for transfer of keys from safes, metal cases and rooms in which medicines of drugs are stored of psychotropic substances and precursors, and devices for sealing affirm the head of institution about what specified persons get acquainted under the personal signature. Job descriptions of responsible persons are constituted according to this Procedure.

6. During administration of drugs of drugs, psychotropic substances and precursors the responsible person shall fulfill the requirements established by MZ.

In case when during administration of drugs of drugs, psychotropic substances and precursors in institution of health care the facts, in particular shortage of such medicines, violation of their integrity of packaging, discrepancy of number of the places specified in the accompanying document are determined, the commission formed by the head of institution of health care draws up the relevant act in triplicate which make sure signatures of her members, health care institutions are sealed. One copy of the act remains at the responsible person, the second is sent to the supplier (seller) together with the receipt document, third is given to accounts department of institution of health care. The statement is drawn up in form according to appendix 1.

7. Accounting of medicines of drugs, psychotropic substances and precursors, is conducted by health care institutions:

in departments and offices of treatment-and-prophylactic institutions in the magazine in form, certain MZ;

on posts of departments of treatment-and-prophylactic institutions in the magazine in form, certain MZ;

in pharmaceutical (pharmaceutical) institutions in the magazine in form, certain MZ;

in treatment-and-prophylactic institutions for accomplishment of appointments of the doctor in stationary conditions on form, certain MZ.

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