RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of September 22, 2021 No. 1002

About modification of Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) and approval of the Standard form of the agreement on implementation of delivery of medicines to the final consumer

The Cabinet of Ministers of Ukraine decides:

1. Bring in the Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 (The Official Bulletin of Ukraine, 2016, No. 99, Art. 3217; 2020, No. 32, the Art. 1088), - with the changes made by the resolution of the Cabinet of Ministers of Ukraine of July 28, 2021 No. 854, changes which are applied.

2. Approve the Standard form of the agreement on implementation of delivery of medicines to the final consumer which is applied.

3. Determine that licensees file to body of licensing the documents specified in paragraphs three, the fourth, sixth the subitem 1 of Item 7 of Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of the medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929, taking into account the changes approved by this resolution no later than within one year from the date of publication of this resolution.

4. This resolution becomes effective from the date of its publication, except Items 15, of 30 changes approved by this resolution which become effective in three months from the date of its publication.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of September 22, 2021 No. 1002

Changes which are made to Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients)

1. To state paragraph two of Item 2 in the following edition:

"The licensee shall fulfill requirements of these Licensed conditions, and the license applicant for its obtaining - to correspond to these Licensed conditions.".

2. In Item 3:

1) to add Item after the paragraph of the thirteenth with paragraphs of the following content:

"electronic retail trade by medicines - retail trade by medicines with use of information and telecommunication systems by remote method which includes acceptance, completing, storage, delivery of orders for medicines and leave of medicines to final consumers;

policy tools of economic activity - the building (room), the equipment which are in property or use of the licensee for the organization of implementation of the activities which are subject to licensing;".

With respect thereto the fourteenth - thirty third to consider paragraphs respectively paragraphs the sixteenth - the thirty fifth;

The paragraph the eighteenth to state 2) in the following edition:

"import of medicines (except active pharmaceutical ingredients) - the activities connected with import to the territory of Ukraine of the registered medicines for the purpose of their further realization, wholesale trade, non-paid supply in case of their purchase by person authorized on implementation of purchases in the field of health care, for the list approved by the Cabinet of Ministers of Ukraine, on condition of confirmation of purpose of import to the territory of Ukraine of such medicines according to the procedure, determined by the Cabinet of Ministers of Ukraine, or use in production of finished pharmaceutical products or medical practice, including storage, quality control, issue of permission to release (realization) of series of the medicine specified in appendix to the license;";

3) to add Item after the paragraph of the eighteenth with the new paragraph of the following content:

"the final consumer (consumer) - physical person which acquires orders, uses or has intention to acquire or order medicine for the personal needs which are directly not connected with business activity or fulfillment of duties of hired employee;".

With respect thereto the nineteenth - the thirty fifth to consider paragraphs respectively paragraphs the twentieth - the thirty sixth;

The paragraph of the twenty sixth to state 4) in the following edition:

"wholesale trade by medicines - activities for acquisition of medicines at producers of medicines or other subjects of managing which have the corresponding license to storage, transportation and sale of medicines from pharmaceutical warehouses (bases) to other subjects of wholesale or retail trade by medicines which obtained the corresponding licenses, to producers of medicines, it is direct to treatment and prevention facilities or legal entities whose structural divisions are treatment and prevention facilities, and also to person authorized on implementation of purchases in the field of health care;";

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

"for subjects of managing which perform wholesale trade by medicines, person having the document on the higher education not below the second (master) level in "Pharmacy, industrial pharmacy" the certificate of the specialist pharmacist issued by organization of post-qualifying education, or the certificate of assignment (confirmation) of the corresponding qualification category and having length of service in "Pharmacy, industrial pharmacy" at least two years to which the subject of managing assigns obligations on functioning of the quality system of medicines during wholesale trade;";

6) to add Item after the paragraph of thirty third with the new paragraph of the following content:

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