ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 12, 2020 No. 2311

About approval of Changes in some regulatory legal acts of the Ministry of Health of Ukraine

According to the paragraph to third the subitem 1, to paragraphs to the seventeenth, eighteenth the subitem 2, to paragraphs to the fifth, sixth the subitem 3 of item 4 of the Section II "Final and transitional provisions" of the Law of Ukraine of March 17, 2020 No. 531-IX "About introduction of amendments to some laws of Ukraine, the medicines allocated for increase in availability, medical products and supportive applications to them which are bought by person authorized on implementation of purchases in the field of health care", to the Law of Ukraine of March 23, 2017 No. 1982-VIII "About modification of some legal acts of Ukraine concerning use of seals by legal entities and physical persons - entrepreneurs", the Law of Ukraine "About medicines", to Item 8 of the Regulations on the Ministry of Health of Ukraine, the Cabinet of Ministers of Ukraine approved by the resolution of March 25, 2015 No. 267 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 to No. 90), for the purpose of enhancement of legal regulation of the state control of quality of medicines in the field of drug circulation and reduction of regulatory legal acts in compliance with the current legislation of Ukraine I ORDER:

1. Approve Changes in some regulatory legal acts of the Ministry of Health of Ukraine which are attached.

2. In accordance with the established procedure to provide to management of provision of medicines (A. Komarid) submission of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the deputy minister concerning the European integration I. Ivashchenko.

4. This order becomes effective from the date of its official publication.

 

It is approved: Acting as Chairman of the Public regulatory service of Ukraine

A. Miroshnichenko

The chairman of Public service of Ukraine on medicines and control of drugs

R. Isayenko

Representative of the Verkhovna Rada of Ukraine for human rights

L. Denisova

Approved by the Order of the Ministry of Health of Ukraine of October 12, 2020 No. 2311

Changes in some regulatory legal acts of the Ministry of Health of Ukraine

1. According to the procedure of quality control of medicines during wholesale and retail trade, No. approved by the order of the Ministry of Health of Ukraine of September 29, 2014 677, registered in the Ministry of Justice of Ukraine on November 26, 2014 for No. 1515/26292:

1) in the Section I:

state Item 1 in the following edition:

"1. This Procedure is developed according to the Law of Ukraine "About medicines", to the Law of Ukraine "About the basic principles of the state supervision (control) in the field of economic activity", to the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 No. 90).";

in Item 7:

the paragraph one after words of "medicines" to add with words "(further - the Order).";

state paragraph two in the following edition:

"In the presence at the subject of managing more than one pharmaceutical institution in respect of prompt actions are determined procedure for receipt by authorized persons of pharmaceutical institutions of information on medicines which turnover is prohibited in Ukraine, the unregistered medicines and distribution of obligations and approval of actions of authorized persons of pharmaceutical institutions in Ukraine regarding provision of information in territorial authority of the central executive body which realizes state policy in spheres of quality control and safety of medicines, including medical immunobiological supplies, medical equipment and medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking, the found low-quality medicines (except for medicines which expiration date expired); medicines which turnover is prohibited in Ukraine; medicines concerning which there was suspicion of falsification; unregistered medicines.";

2) in the Section II:

state Item 1 in the following edition:

"1. Incoming inspection of quality of the medicines arriving in drugstore performs the authorized person designated by the order of the head of the subject of managing. Its surname, contact telephone number and form of communication (phone, the fax, e-mail) should be reported within a month after appointment of the authorized person in territorial authority of the central executive body which realizes state policy in spheres of quality control and safety of medicines, including medical immunobiological supplies, medical equipment and medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking. Preparation and execution of the conclusion of incoming inspection of quality of medicines with mark about their transfer to realization are within the competence of the authorized person.";

in Item 2:

state subitem 2 in the following edition:

"To draw up 2) in paper or electronic type (in the presence of the corresponding electronic system of accounting with authentication of users and differentiation of access) the conclusion of incoming inspection of quality of medicines by mark in receipt documents of result positive/negative, is authorized / it is not authorized to realization, with identification of date of its carrying out and the authorized person;";

in subitem 3 of the word and figure "the register of the medicines which arrived to the subject of managing (appendix 1), and maintaining", "urgent" to exclude;

state subitem 5 in the following edition:

"To provide 5) in territorial authority of the central executive body which realizes state policy in spheres of quality control and safety of medicines, including medical immunobiological supplies, medical equipment and medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking, information on the found low-quality medicines (except for medicines which expiration date expired); medicines concerning which there was suspicion of falsification; counterfeited and unregistered medicines. In case of identification of samples of such medicines to take measures concerning withdrawal them from the address by the room to the specially allotted, accurately certain, marked quarantine zone (room), separately from other products, with the designation "Quarantine" with indication of the reasons of retirement and date of movement;";

state subitem 7 in the following edition:

"7) to provide permanent implementation of monitoring of storage conditions of medicines according to requirements of the instruction for medical application of medicine;";

state subitem 8 in the following edition:

"8) to provide permission to realization (leave) of medicines.";

in Item 3:

state subitem 1 in the following edition:

"1) it is necessary to buy and receive medicines only at subjects of managing which have licenses for implementation of economic activity on production of medicines, wholesale trade by medicines, import of medicines according to entry in the licensed register;";

in subitem 2 "written" to exclude the word;

state subitem 3 in the following edition:

"3) the authorized person checks compliance of the received medicines to accompanying documents concerning the name, quantities, numbers of series, expiration date of medicines, information on the supplier, dosing, medical form, the producer, the registration status according to the State register of medicines. Each series of medicine shall be followed in paper or electronic type by the copy of the quality certificate of series of medicine which is issued by the producer (for the imported medicines - the importer (the producer or person who represents producer of medicines in the territory of Ukraine)), the conclusions about quality of the medicine imported into Ukraine (for medicines of foreign production) and the conclusions about MIBP compliance to requirements of the state and international standards (for medical immunobiological supplies), certified by seal of the last supplier (in case of its availability);";

state subitem 5 in the following edition:

"5) in case of positive result of incoming inspection the authorized person grants permission for realization (leave) of the received series of medicines in paper or electronic type;";

state subitem 6 in the following edition:

"6) in case of negative result the authorized person draws up the statement of the revealed discrepancies which is the basis for return of batch to the supplier.

Of the medicines imported with violation of the law and medicines which expiration date expired the authorized person in ten-day time informs territorial authority of the central executive body which realizes state policy in spheres of quality control and safety of medicines, including medical immunobiological supplies, medical equipment and medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking with provision of copies of accompanying documents on the fact of detection of supply of medicines which turnover is prohibited by Orders;";

3) in the Section III:

state Item 1 in the following edition:

"1. Each subject of managing which has the license for implementation of economic activity on wholesale trade by medicines shall provide carrying out incoming inspection of quality of medicines.

Incoming inspection of quality of the medicines arriving to the subject of managing performs the authorized person designated by the order of the head of the subject of managing. Preparation and execution of the conclusion of incoming inspection of quality of medicines with mark about their transfer to realization (leave) are within the competence of the authorized person.";

in Item 2:

state subitem 2 in the following edition:

"To draw up 2) in paper or electronic type (in the presence of the corresponding electronic system of accounting with authentication of users and differentiation of access) the conclusion of incoming inspection of quality of medicines by mark in receipt documents of result positive/negative, is authorized / it is not authorized to realization, with identification of date of its carrying out and the authorized person;";

in subitem 3 of the word and figure "the register of the medicines which arrived to the subject of managing (appendix 1), and maintaining", "urgent" to exclude;

state subitem 4 in the following edition:

"4) to provide possibility of forming of registers of movement of medicines which are implemented by the subject of managing, in electronic or paper type to have opportunity, in case of need, to withdraw series of medicines;";

state subitem 6 in the following edition:

"To provide 6) in territorial authority of the central executive body which realizes state policy in spheres of quality control and safety of medicines, including medical immunobiological supplies, medical equipment and medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking, information on the found low-quality medicines (except for medicines which expiration date expired); medicines concerning which there was suspicion of falsification; the counterfeited and unregistered medicines (except the cases determined by the Law of Ukraine "About medicines" regarding the medicines which are purchased by the authorized person on implementation of purchases in the field of health care). In case of identification of samples of such medicines to take measures concerning withdrawal them from the address by the room to the specially allotted, accurately certain, marked quarantine zone (room), separately from other products, with the designation "Quarantine" with possibility of identification of the reasons of withdrawal and date of placement.

For large volumes of quarantine goods placement it in general zone of storage on condition of ensuring accurate alarm marking of quarantine products and additional resources of safety (including with use of electronic systems of accounting) which prevent shipment of quarantine goods which are determined in standard operational procedures and the legislation is allowed;";

state subitem 7 in the following edition:

"7) to provide permanent implementation of monitoring of storage conditions of medicines according to requirements of the instruction for medical application of medicine;";

state subitem 8 in the following edition:

"8) to provide permission to realization (leave) of the received series of medicines.";

in Item 3:

state subitem 1 in the following edition:

"1) it is necessary to buy and receive medicines only at subjects of managing which have licenses for implementation of economic activity on production of medicines, wholesale trade by medicines, import of medicines according to entry in the licensed register. It is allowed to receive in ownership medicines from the face, authorized on implementation of purchases in the field of health care, without transition of the property right to such medicines;";

in subitem 2:

in the second offer to replace the word "entrance" with the word "visual";

"written" to exclude the word;

state subitem 3 in the following edition:

"3) the authorized person checks compliance of the received medicines to accompanying documents concerning the name, quantities, dosing, numbers of series, expiration dates of medicines, the registration status, the name, medical form, the producer, information on the supplier. Each series of medicines shall be followed (in paper or electronic type) by the copy of the quality certificate which is issued by the producer (for the imported medicines - the importer (the producer or person who represents producer of medicines in the territory of Ukraine)), the conclusions about quality of the medicine imported into Ukraine (for medicines of foreign production), the conclusions about MIBP compliance to requirements of the state and state and international standards (for medical immunobiological supplies), certified by seal of the last supplier (in case of its availability); ";

state subitem 5 in the following edition:

"5) in case of positive result of incoming inspection the authorized person grants permission for realization (leave) of the received series of medicines in paper or electronic type;";

state subitem 6 in the following edition:

"6) in case of negative result the authorized person draws up the statement of the revealed discrepancies which is the basis for return of batch to the supplier.

Of the medicines imported with violation of the law and medicines which expiration date expired the authorized person in ten-day time informs territorial authority of the central executive body which realizes state policy in spheres of quality control and safety of medicines, including medical immunobiological supplies, medical equipment and medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking with provision of copies of accompanying documents on the fact of detection of supply of medicines which turnover is prohibited by Orders;";

add subitem 7 with the new paragraph of such content:

"For large volumes of quarantine goods placement it in general zone of storage on condition of ensuring accurate alarm marking of quarantine products and additional resources of safety (including with use of electronic systems of accounting) which prevent shipment of quarantine goods which are determined in standard operational procedures and the legislation is allowed.";

Paragraph two of item 4 of the Section IV to state 4) in the following edition:

"In case of establishment of temporary ban (prohibition) of the address of medicine subjects of managing shall in time, determined on hand about introduction of temporary ban (prohibition) of turnover, to take measures for accomplishment of the requirements established by such Order.";

Appendix 1 and 2 to this Procedure to exclude 5).

With respect thereto to consider appendix 3 appendix 1;

The word "order" to replace 6) in appendix 1 to this Procedure with the word "Order".

Shall be replaced with words 7) in the text and appendices to this Procedure for the word of "products of medical appointment" "medical products".

2. According to the procedure of carrying out industry certification of laboratories for quality control and safety of medicines, No. approved by the order of the Ministry of Health of Ukraine of January 14, 2004 10, registered in the Ministry of Justice of Ukraine on January 30, 2004 for No. 130/8729:

Item 5.2 of the Section 5 after the word to "person" to add 1) with the words "in paper and/or electronic type";

In the text of appendices 1 and 4 after the words "Seal" to add 2) with words "(in case of its availability)".

3. In the text of appendix 3 to the Instruction for registration of materials about administrative offenses of the legislation of Ukraine concerning quality assurance of medicines approved by the order of the Ministry of Health of Ukraine of October 26, 2001 No. 428, registered in the Ministry of Justice of Ukraine on January 18, 2002 for No. 47/6335 after the words "certified by seal" to add with words "(in case of its availability)".

4. In Item 1 of the Section II of the Procedure of control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards, the Ministry of Health of Ukraine approved by the order of October 01, 2014 No. 698, registered in the Ministry of Justice of Ukraine on October 29, 2014 for No. 1356/26133:

Paragraph two of subitem 1 to state 1) in the following edition:

"Documents are filed in paper (in duplicate) and/or electronic type.";

Subitem 2 to add 2) with the new paragraph of such content:

"In case of lack of the license for implementation of economic activity on import of medicines at person authorized on implementation of purchases in the field of health care, ensuring compliance with the legislation on licensing of types of economic activity during import to the territory of Ukraine, storage, quality control, issue of permission to release (realization) of series of medicines which are bought by person authorized on implementation of purchases in the field of health care is performed by involvement of subjects of managing who have the license for implementation of economic activity on import of medicines, with compliance with law in the field of public purchases. The expiration date of medicines which are bought and imported on the territory of Ukraine by person authorized on implementation of purchases in the field of health care according to 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, shall constitute at least 70 percent from expiration date of the medicine established by the producer.".

5. In Storage precautions and monitoring procedures of quality of medicines in the treatment and prevention facilities approved by the order of the Ministry of Health of Ukraine of December 16, 2003 No. 584, registered in the Ministry of Justice of Ukraine on March 03, 2004 for No. 275/8874 (in edition of the order of the Ministry of Health of Ukraine of April 03, 2018 No. 610):

1) in the Section I:

"unregistered in Ukraine" to add Item 5 after words with words "(except the cases determined by the Law of Ukraine "About medicines");";

2) in the Section V:

in Item 3:

to add the paragraph of the sixth after the words "registered in Ukraine" with words "(except the cases determined by the Law of Ukraine "About medicines")";

to add the paragraph of the seventh after the words "unregistered medicines" with words "(except the cases determined by the Law of Ukraine "About medicines")".

6. According to the procedure of establishment of prohibition (temporary ban) and renewal of drug circulation in the territory of Ukraine, No. approved by the order of the Ministry of Health of Ukraine of November 22, 2011 809, registered in the Ministry of Justice of Ukraine on January 30, 2012 for No. 126/20439:

Paragraph one of Item 2.1 of the Section II to state 1) in the following edition:

"2.1. In case of factual determination of turnover of the low-quality, counterfeited, unregistered medicines (except the cases determined by the Law of Ukraine "About medicines") Gosleksluzhba:";

2) in the Section III:

to add paragraph two of the subitem 1 of Item 3.2 after words of "the unregistered medicine" with words "(except the cases determined by the Law of Ukraine "About medicines")".;

to add subitem 3.2.2 of Item 3.2 after words of "the unregistered medicine" with words "(except the cases determined by the Law of Ukraine "About medicines");";

Paragraph one of the subitem 1 of Item 4.1 of the Section IV after words of "the unregistered medicines" to add 3) with words "(except the cases determined by the Law of Ukraine "About medicines")".

 

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