THE ORDER OF THE STATE COMMITTEE OF UKRAINE CONCERNING REGULATORY POLICY AND THE ENTREPRENEURSHIP, THE STATE INSPECTORATE FOR CONTROL OF MEDICINES

of June 10, 2009 No. 98/130

About approval of the Procedure for control of observance of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines

According to Articles 5, of 6, of 8, 9 Laws of Ukraine "About licensing of certain types of economic activity", the resolution of the Cabinet of Ministers of Ukraine of 14.11.2000 N 1698 "About approval of the list of bodies of licensing" we ORDER:

1. Approve the Procedure for control of observance of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines which is applied.

2. To the director of the department of licensing of the State committee of Ukraine concerning regulatory policy and entrepreneurship (Ivanchenko O. B.), to the head of department of licensing and control of observance of licensed conditions of the State inspectorate for quality control of medicines (Sheremet V. V.) in accordance with the established procedure to provide provision of this order on state registration in the Ministry of Justice of Ukraine.

3. To the head of department of licensing and control of observance of licensed conditions of the State inspectorate for quality control of medicines (Sheremet V. V.) to provide the publication of this order in mass media.

4. To impose control over the implementation of this order on the vice-chairman of the State committee of Ukraine concerning regulatory policy and entrepreneurship Tretyakov S. I. and vice-chairman of the State inspectorate for quality control of medicines Zakharash A. D.

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

 

Chairman of the State committee Ukraine concerning regulatory politicians and entrepreneurships

O. V. Kuzhel

Chairman State inspectorates for quality control medicines

G. V. Padalko

Approved by the Order of the State committee of Ukraine concerning regulatory policy and entrepreneurship, the State inspectorate for quality control of medicines of June 10, 2009, No. 98/130

Procedure for control of observance of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines

I. General provisions

1.1. This Procedure is developed according to the Laws of Ukraine "About licensing of certain types of economic activity", "About the basic principles of the state supervision (control) in the field of economic activity", Bases of the legislation of Ukraine on health care, the resolution of the Cabinet of Ministers of Ukraine of 14.11.2000 N 1698 "About approval of the list of bodies of licensing", the order of the State committee of Ukraine concerning regulatory policy and entrepreneurship and the State inspectorate for quality control of medicines of 03.03.2009 N 44/27 "About approval of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines", registered in the Ministry of Justice of Ukraine 02.04.2009 for N 298/16314 (further - Licensed conditions).

1.2. Action of this Procedure extends to all subjects of housekeeping (legal entities and physical persons - subjects of business activity) who obtained the license of Public service of medicines and products of medical appointment to implementation of economic activity on production of medicines, wholesale, retail trade by medicines till 01.01.2009 or the State inspectorate for quality control of medicines from 01.01.2009.

1.3. Control of observance by subjects of housekeeping of Licensed conditions within the powers by carrying out scheduled and unscheduled inspections is performed by control facilities:

The state inspectorate for quality control of medicines (further - Goslekinspektion) and its territorial organygosudarstvenny inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, Kiev and Sevastopol (daleeterritorialny bodies of Goslekinspektion) as body of licensing;

The state committee of Ukraine concerning regulatory policy and entrepreneurship (further - the State Committee of Ukraine on Regulatory Policy and Entrepreneurship) and its territorial authorities as specially authorized body concerning licensing.

1.4. In this Procedure the terms below are used in such value:

the act is the document processed in accordance with the established procedure which is constituted by officials of control facilities by results of check of observance by the licensee of Licensed conditions (the inspection statement of observance by the licensee of Licensed conditions; act of further violation by the licensee of Licensed conditions; the act of factual determination of transfer of the license or its copy to other legal entity or physical person for implementation of economic activity; the act of detection of false information in the documents filed by the subject of housekeeping for receipt of the license; the act of failure to provide factual determination at the scheduled time of the message on change of the data specified in documents which were enclosed to the application for licensing; act of failure to carry out of the order of elimination of violations of Licensed conditions; the act of refusal of the licensee in conducting check by body of licensing or specially authorized body concerning licensing; the act of inability of the licensee to provide accomplishment of the Licensed conditions established for certain type of economic activity);

refusal of the licensee in conducting check - check avoidance, making of obstacles from the licensee in access for officials of control facility to its territory and/or to buildings, constructions, rooms of the subject of housekeeping which are used for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, creations of obstacles in work of officials of control facility from the licensee, not appointment as the licensee of the person authorized by it having the right to represent the licensee during conducting check in case of absence of the head of the licensee (legal entity) or the licensee - the physical person - the entrepreneur, refusal in provision of documents, information concerning check subject upon the demand of officials of control facility;

control of observance of Licensed conditions is set of the organizational and legal actions directed to check of observance by licensees of organizational, qualification and other special requirements for implementation of economic activity on production of medicines, wholesale, retail trade by medicines;

critical violation of Licensed conditions of industrial production of medicines - violation (discrepancy) of Licensed conditions or requirements of the registration file on medicine that brought or can lead to production of low-quality medicine, wholesale, retail trade by low-quality medicines which can do harm to health or human life (determination is applied to industrial production of medicines);

the licensee - the subject of housekeeping who obtained the license for implementation of certain type of the economic activity which is subject to licensing;

unauthenticity of data in the documents filed by the subject of housekeeping for receipt of the license - establishment of the location of the legal entity or the residence of the physical person - the subject of business activity or the place of the implementation of economic activity which is not specified in the statement or other documents filed by the subject of housekeeping for receipt of the license, and also other discrepancies between the data stated in the filed documents and which is available material, regulatory framework, qualification of personnel (workers) established when checking the subject of housekeeping;

impossibility of the licensee to provide accomplishment of Licensed conditions - lack of material and technical resources (rooms, the equipment) for implementation of production of medicines, wholesale, retail trade with medicines in the places of implementation of economic activity specified in the documents enclosed to the application for receipt of the license; absence of specialists who shall have the corresponding vocational education and meets single qualification requirements;

failure to provide the message on change of the data specified in documents which were enclosed to the application for licensing, identification of the fact of failure to provide in the time determined by the legislation in body of licensing together with the relevant documents of the message in writing on all changes of the data specified in documents which were enclosed to the application for licensing;

insignificant violation of Licensed conditions of industrial production of medicines - violation (discrepancy) which cannot entail production of low-quality medicine of wholesale, retail trade by low-quality medicines and can be eliminated at the time of check or in the shortest possible time and which does not belong to critical or fundamental breaches (determination is applied to industrial production of medicines);

further violation of Licensed conditions - making by the licensee during effective period of the license of further violation of certain Licensed conditions after application of sanctions for similar violation;

the order about elimination of violations Licensed usloviyresheniye of control facilities about need of elimination by the licensee at the scheduled time of violations of Licensed conditions;

the subject of housekeeping - the legal entity irrespective of its form of business and pattern of ownership who is carrying out economic activity, and also the physical person registered in the procedure established by the legislation - the subject of business activity;

fundamental breach of Licensed conditions of industrial production of medicines - violation (discrepancy) of Licensed conditions which brought or can lead to production of low-quality medicine, wholesale, retail trade by low-quality medicines that cannot do harm to health or human life (determination is applied to industrial production of medicines).

II. Organization of checks

2.1. Scheduled inspections of observance by licensees of Licensed conditions are carried out by control facilities not more often than once a year.

Scheduled inspections of the subjects of housekeeping performing economic activity on production of medicines are carried out by control facilities at least once in two years.

2.2. Scheduled inspections of observance by the licensee of Licensed conditions are carried out by control facilities according to quarter plans of conducting checks which affirm the order of body of licensing to the 25th day of the last month of the quarter previous planned with obligatory informing the State Committee of Ukraine on Regulatory Policy and Entrepreneurship.

2.3. Plans of conducting checks will quarterly be unveiled by control facilities by placement of information on the Internet on the official website of control facility.

2.4. Control facilities perform scheduled inspections on condition of the written message to the subject of housekeeping about conducting such check not later than ten days about day of carrying out.

2.5. The message on conducting check is sent to the licensee by the registered mail on the location of the licensee on which by the licensee it shall be provided correspondence, or handed personally to the head or the authorized person of the subject of housekeeping on receipt.

The subject of housekeeping has the right not to allow the official of control facility to implementation of scheduled inspection in case of non receipt of the message on its carrying out.

Non receipt by the licensee of the message on conducting planned inspection is not the basis for refusal in conducting check if such message on conducting check was timely sent by the registered mail and is returned to control facility with the assurance of receipt or not delivery (with indication of the bases).

2.6. The term of implementation of scheduled inspection cannot exceed fifteen working days, and for subjects small predprinimatelstvapyat of the working days.

Prolongation of term of implementation of scheduled inspection is not allowed.

2.7. Unscheduled inspections are performed by control facilities on the bases determined by the Laws of Ukraine "About licensing of certain types of economic activity" and "About the basic principles of the state supervision (control) in the field of economic activity".

During unscheduled inspections the questions which became the basis for conducting these checks become clear.

2.8. The term of implementation of unscheduled inspection cannot exceed five working days, and concerning small business entities - two working days.

Prolongation of term of implementation of unscheduled inspection is not allowed.

2.9. In check specialists of the ministries, other executive bodies and local government bodies can be recruited (in their consent).

III. Rights of officials of control facilities and right of the licensee

3.1. Officials of control facilities when implementing checks behind observance of Licensed conditions have the right:

access to the territory of the licensee, to its production and other rooms which are used for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, for inspection and clarification of the questions which are directly connected with check;

study the normative and technical, accounting and reporting, ordering, statistical and other documentation necessary for conducting check;

receive copies (photocopy) of the necessary documents which are directly connected with check;

select samples of medicines for laboratory check of their quality in case of establishment of violations of the production technology, quality control, conditions and/or storage precautions of medicines which can entail production of low-quality medicines and/or wholesale, retail trade by low-quality medicines;

receive from the licensee written explanations on the questions arising during check.

3.2. The licensee during implementation of check has the right:

demand from officials of control facility of observance of requirements of the legislation;

check availability at officials of control facility of the official ID and receive copies of the certificate on carrying out scheduled or unscheduled inspection;

get acquainted with the basis of carrying out unscheduled inspection with receipt of the copy of the relevant document;

be present during check implementation;

require nondisclosure of information which is trade secret of the licensee;

receive one copy of the act and get acquainted with it;

provide in writing the explanations, notes or objections to the act;

appeal wrongful acts of control facilities and their officials in the procedure established by the law;

not allow officials of control facility to check implementation if:

check is performed with violation of requirements concerning frequency of conducting the checks provided by this Procedure;

the official of control facility did not provide the copy of the documents provided by this Procedure or if the provided documents do not meet the requirements of the current legislation.

IV. Obligations of officials of control facility and obligation of the licensee

4.1. The officials performing shall:

be guided in the work as the legislation of Ukraine;

to objectively display the state of affairs concerning observance by licensees of Licensed conditions;

provide observance state and another, provided by the current legislation, secrets.

4.2. The licensee shall:

allow officials of control facility to implementation of check on condition of observance of this Procedure;

fulfill requirements of control facility concerning elimination of the revealed violations of requirements of the legislation.

V. Procedure for conducting check

5.1. For implementation of scheduled or unscheduled inspection the control facility issues the order which shall contain the name of the licensee concerning which check, subject of check and surname, names and middle names of officials which will perform will be performed.

5.2. Based on the order the certificate on conducting check which is signed by the head or the deputy manager of control facility is drawn up and makes sure seal of control facility (appendix 1).

5.3. Certificates are registered in register of certificates on conducting check of licensees which pages shall be numbered, strung together and under seal (appendix 2).

The certificate is effective only during the check implementation term specified in it.

5.4. Before conducting check officials of control facility shall show to the head of the subject of housekeeping or person of the certificate authorized by it on the conducting check and the official ID certifying the official of state control body and to provide to the subject of housekeeping the copy of the certificate on conducting check.

When carrying out unscheduled inspection the subject of housekeeping shall get acquainted with the basis of its carrying out with provision to it the copy of the relevant document.

5.5. The official of control facility without certificate has no right to perform check of the subject of housekeeping to conducting check and the official ID.

5.6. The subject of housekeeping has the right not to allow officials of control facility to check implementation if they did not show the documents provided by this Procedure.

5.7. The licensee can keep the magazine of visits by representatives of control facilities with indication of in it terms and the purpose of visit, position, surname, initials of the official of control facility.

The specified data make sure the signature of the official of control facility.

5.8. Are subject to check material and technical resources of the licensee in the place of direct implementation of economic activity and observance of organizational, qualification, special requirements of Licensed conditions by it.

5.9. The licensee during check of observance of Licensed conditions by it provides conditions for its carrying out and provides on demand to officials of control facility for conducting check:

5.9.1. On production of medicines:

constituent documents (charter of the company, foundation agreement), certificate of inclusion in EGRPOU, certificate on state registration;

original of the license and copy of the license (in the presence);

the documents confirming the property right or uses of the room which is occupied by the subject of housekeeping or its isolated structural division;

copies of the regulatory legal acts regulating the activities connected with the address (production) of medicines;

documents on confirmation of state registration of medicines which are made;

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