RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of September 8, 2021 No. 939

About modification of Licensed conditions of implementation of economic activity on cultivation of the plants included in the table I of the list of drugs, psychotropic substances and precursors approved by the Cabinet of Ministers of Ukraine, development, production, to production, storage, transportation, acquisition, realization (leave), import to the territory of Ukraine, export from the territory of Ukraine, to use, destruction of the drugs, psychotropic substances and precursors included in the specified list

The Cabinet of Ministers of Ukraine decides:

1. Bring in Licensed conditions of implementation of economic activity on cultivation of the plants included in the table I of the list of drugs, psychotropic substances and precursors approved by the Cabinet of Ministers of Ukraine, development, production, to production, storage, transportation, acquisition, realization (leave), import to the territory of Ukraine, export from the territory of Ukraine, to use, destruction of the drugs, psychotropic substances and precursors included in the specified list, "Some questions of licensing of economic activity approved by the resolution of the Cabinet of Ministers of Ukraine of April 6, 2016 No. 282 on cultivation of the plants included in the table I of the list of drugs, psychotropic substances and precursors approved by the Cabinet of Ministers of Ukraine, to development, production, production, storage, transportation, acquisition, realization (leave), import to the territory of Ukraine to export from the territory of Ukraine, use, to destruction of the drugs, psychotropic substances and precursors included in the specified list" (The Official Bulletin of Ukraine, 2016, No. 30, Art. 1209; 2020, No. 63, the Art. 2047), changes which are applied.

2. This resolution becomes effective from the date of its publication, except Item of 12 changes approved by this resolution which becomes effective in three months from the date of publication of this resolution.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of September 8, 2021 No. 939

Changes which are made to Licensed conditions of implementation of economic activity on cultivation of the plants included in the table I of the list of drugs, psychotropic substances and precursors approved by the Cabinet of Ministers of Ukraine, to development, production, production, storage, transportation, acquisition, realization (leave), import to the territory of Ukraine, export from the territory of Ukraine, to use, destruction of the drugs, psychotropic substances and precursors included in the specified list

1. In Item 6:

The subitem 2 after words of "the connected with drug trafficking, psychotropic substances and precursors" to add 1) with words "(in the form established by the Ministry of Health)";

Subitems 3 and 4 to exclude 2);

Subitem 6 to state 3) in the following edition:

"6) data relatively:

conditions of material and technical resources of the subject of managing and availability of personnel with indication of its qualification level;

availability of permission of National police to use of the objects and rooms intended for implementation of economic activity on drug trafficking, psychotropic substances and precursors;

absence at workers who on the office to obligations will receive (or have) access directly to drugs, psychotropic substances and precursors, the criminal record which is not removed or not extinguished in accordance with the established procedure for making of the not heavy, heavy and especially serious crimes or criminal offenses connected with drug trafficking, psychotropic substances and precursors, including those which are made outside Ukraine (appendix 3).

Pages of data are numbered, certified by the signature of the subject of managing (authorized person);".

2. State Item 9 in the following edition:

"9. In case of the basis for renewal of the license the heir (the physical person entrepreneur having the license for implementation of medical or veterinary practice) shall submit within one month to body of licensing the application for renewal of the license in form according to appendix 8 and documents (their copy (photocopy) certified by the heir) confirming availability of the bases for renewal of the license. Such license is subject to renewal addressed to the heir on condition of compliance of the heir to requirements of these Licensed conditions.".

3. To add Item 10 after words of "type of economic activity" with the word and figure" (appendix 5)".

4. "With Item of 6 presents of Licensed conditions" to add Item 11 after words and figure with the word and figure" (appendix 4)".

5. State Item 13 in the following edition:

"13. The licensee shall notify body of licensing on all changes of the data specified in the statement, documents and data enclosed to the application for receipt of the license and to provide within one month from the date of approach of such changes to body of licensing the adequate notice in written (the courier, the mailing with the inventory of investment) or electronic form.".

6. In Item 16:

The paragraph third to state 1) in the following edition:

"till January 31 of the year following the accounting period - the report on amount of drugs, psychotropic substances and precursors which are made, made, imported on the territory of Ukraine are exported from the territory of Ukraine, are implemented or used, and also about quantity of inventories of drugs, psychotropic substances and precursors as of December 31 of accounting year;";

2) to add Item with the paragraph of the following content:

"till December 1 of the current year - the report on results of economic activity with indication of quantity of the grown-up and processed plants of type of poppy of sleeping pill and plants of sort hemp for production of seeds.".

7. State Item 19 in the following edition:

"19. Faces of administrative board to whom obligations on control of drug trafficking are assigned psychotropic substances and precursors, responsible persons and persons who on job responsibilities will get access to drug trafficking, of psychotropic substances and precursors, are determined by the order of the head of the legal entity (authorized person) or physical person entrepreneur having the license for implementation of medical or veterinary practice.".

8. To state paragraph two of Item 20 in the following edition:

"The objects and rooms intended for implementation of economic activity on drug trafficking, psychotropic substances and precursors procedure for access and stay in them are determined by the order of the head of the legal entity (authorized person) or physical person entrepreneur.".

9. Add Licensed conditions with Item 29-1 of the following content:

"29-1. In case of suspension of action of the license fully or partially (types of economic activity on use, storage) the head of the legal entity (authorized person), physical person entrepreneur shall carry out inventory count of drugs, psychotropic substances and precursors in the procedure determined by the legislation with creation of balance of inventory items. The licensee sends the copy of the specified balance to Gosleksluzhbu within two working days from the date of inventory count completion.

Drugs, psychotropic substances and precursors before renewal of action of the license fully or partially (types of economic activity on use, storage) are stored in the locked safes (metal cases) or storage facilities which conform to the requirements established by these Licensed conditions.

In case in the place of implementation of economic activity which is specified in the decision on suspension of action of the license it is impossible to provide observance of conditions for storage of drugs, psychotropic substances and precursors, the licensee shall transfer them to storage to the licensee which confirmed compliance to requirements of these Licensed conditions, or return to the supplier (producer), or to take measures to their destruction.

After submission by the licensee of the statement and data on elimination of the bases which served as the reason for suspension of action of the license fully or partially in case of suspension of action of the license based on the act of failure to carry out of the order of elimination of violations of licensed conditions of implementation of type of economic activity (regarding type of economic activity) - information on payment of penalty, action of the license is recovered fully or partially.

Application for suspension of action of the license is issued according to appendix 6.

Application for renewal of action of the license is issued according to appendix 7.".

10. In Item 31:

Subitem 3 to state 1) in the following edition:

"3) production of the drugs, psychotropic substances and precursors registered as medicines are persons having the higher education not below the second (master) level in "Pharmacy, industrial pharmacy", "Chemical technologies and engineering", "Biotechnologies and bioengineering", "Biomedical engineering", "Chemistry", "Biology", and persons having the corresponding professional prehigher education on educational and professional degree of the professional junior bachelor;";

The paragraph third subitem 5 to state 2) in the following edition:

"during production, production of medicines - persons having the higher education not below the second (master) level in "Pharmacy, industrial pharmacy", "Chemical technologies and engineering", "Biotechnologies and bioengineering", "Biomedical engineering", "Chemistry", "Biology", and persons having the corresponding professional prehigher education on educational and professional degree of the professional junior bachelor;".

11. In the paragraph the second Items 81 and 82 to exclude the word "separate".

12. Add Licensed conditions with Item 85-1 of the following content:

"85-1. The licensee provides availability of places of implementation of economic activity to handicapped national groups.".

13. In appendices to Licensed conditions:

Appendices 1 and 3 to state 1) in the following edition:

"Appendix 1

to Licensed conditions (in edition of the resolution of the Cabinet of Ministers of Ukraine of September 8, 2021 No. 939)

Statement for receipt of the license";

See Appendix 1 (15Kb In original language)

"Appendix 3

to Licensed conditions (in edition of the resolution of the Cabinet of Ministers of Ukraine of September 8, 2021 No. 939)

Data on condition of material and technical resources of the subject of managing and availability of personnel with indication of its qualification level; about availability of permission of National police to use of the objects and rooms intended for implementation of economic activity on drug trafficking, psychotropic substances and precursors; about absence at workers who on the service duties will receive (or have) access directly to drugs, psychotropic substances and precursors, the criminal record which is not removed or not extinguished in accordance with the established procedure for making of the not heavy, heavy and especially serious crimes or criminal offenses connected with drug trafficking, psychotropic substances and precursors, including those which are made outside Ukraine";

See Appendix 3 (13Kb In original language)

2) to add Licensed conditions with appendices 4 - 8 following contents:

"Appendix 4

to Licensed conditions

Statement for expansion of implementation of type of economic activity

See Appendix 4 (11Kb In original language)

Appendix 5

to Licensed conditions

Statement for narrowing of implementation of type of economic activity

See Appendix 5 (11Kb In original language)

Appendix 6

to Licensed conditions

Statement for suspension fully or partially actions of the license

See Appendix 6 (11Kb In original language)

Appendix 7

to Licensed conditions

Statement for recovery (fully or partially) actions of the license

See Appendix 7 (11Kb In original language)

Appendix 8

to Licensed conditions

Statement for renewal of the license".

See Appendix 8 (12Kb In original language)

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