ORDER OF THE STATE INSPECTORATE FOR QUALITY CONTROL OF MEDICINES OF THE MINISTRY OF HEALTH OF UKRAINE

of September 21, 2010 No. 339

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

According to Articles 6, 20, 21 Law of Ukraine "About licensing of certain types of economic activity", the Law of Ukraine "About the basic principles of the state supervision (control) in the field of economic activity", resolutions of the Cabinet of Ministers of Ukraine of 14.11.2000 N 1698 "About approval of the list of bodies of licensing" (with changes). I ORDER:

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

2. In accordance with the established procedure to provide to the vice-chairman of the State inspectorate for quality control of medicines of the Ministry of Health of Ukraine (Kropivny O. O.) submission of this order on state registration in the Ministry of Justice of Ukraine and its publication in mass media.

3. To impose control over the implementation of this order on the vice-chairman of the State inspectorate for quality control of medicines of the Ministry of Health of Ukraine of Kropivny O. O.

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

 

Chief state inspector Ukraine on quality control medicines

O. S. Solovyov

IN COORDINATION: Acting Minister health cares of Ukraine

S. A. Ryzhenko

Chairman of the State committee Ukraine concerning regulatory politicians and entrepreneurships

M. Brodsky

Approved by the Order of the State inspectorate for quality control of medicines of the Ministry of Health of Ukraine of September 21, 2010, No. 339

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

I. General provisions

1.1. This Procedure Osnov legislations of Ukraine on health care, resolutions of the Cabinet of Ministers of Ukraine, of 14.11.2000 N 1698 "About approval of the list of bodies of licensing" 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".

1.2. Action of this Procedure extends to all subjects of maintaining (legal entities and physical persons - subjects of business activity) farms who obtained the license for conducting economic activity on production of medicines, wholesale, retail trade by medicines, in accordance with the established procedure.

1.3. Control of observance by subjects of housekeeping of Licensed conditions within the powers by carrying out scheduled and unscheduled inspections perform the State inspectorate for quality control of medicines of the Ministry of Health of Ukraine (further - Goslekinspektion MZ) and its territorial authorities - the state inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol (further - territorial authorities of Goslekinspektion of MZ) as body of licensing.

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

the act - 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 conducting economic activity; the act of detection of false information in the documents submitted by the subject of housekeeping for receipt of the license; 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 impossibility of the licensee to provide accomplishment of the Licensed conditions established for certain type of economic activity);

refusal of the licensee in conducting check - creation 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, 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 - physical litsapredprinimatel, refusal in provision of documents, information concerning check subject upon the demand of officials of control facility;

control of observance of Licensed conditions - set of the organizational and legal actions directed to check of observance by licensees of organizational, qualification and other special requirements for conducting 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 which brought or can lead to production of low-quality medicine, wholesale, retail trade by low-quality medicines which can do harm for health or human life (determination is applied to industrial production of medicines);

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

unauthenticity of data in the documents submitted by the subject of housekeeping for receipt of the license, - establishment of the location of the legal entity or residence of the physical person - the subject of business activity or the place of implementation of economic activity which is not noted in the statement or other documents submitted by the subject of housekeeping for receipt of the license, and also other discrepancies, between the data stated in the submitted documents, and available material, regulatory framework, qualification of personnel (workers) which are 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 conducting production of medicines, wholesale, retail trade with medicines, in places of implementation of economic activity which are noted 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;

not submission of the notification on change of the data noted in the documents 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 notification in writing on all changes of the data noted in documents which were enclosed to the application for licensing;

insignificant violation of Licensed conditions of industrial production of medicines - violations (discrepancy) which cannot lead to production of low-quality medicine, 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 performing economic activity, and also the physical person registered in the procedure established by the legislation - the entrepreneur;

fundamental breach of Licensed conditions of industrial production of medicines - violations (discrepancy) of Licensed conditions which brought or can lead to production of low-quality medicine, wholesale, retail trade by low-quality medicines, but cannot do harm for 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 performed by control facilities according to Criterion by which the risk degree from conducting activities in the field of health care for safety of life and health of the population is estimated and frequency of implementation of planned actions of the state supervision (control), by the approved resolution of the Cabinet of Ministers of Ukraine, of 10.09.2008 N 843 is determined.

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 preceding planned. Within ten working days after approval of the scheduled plan of checks the body of licensing provides the copy of the scheduled plan and the order on its approval in the State Committee of Ukraine on Regulatory Policy and Entrepreneurship.

2.3. Plans of conducting checks will 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 notice of the subject of housekeeping of conducting such check not later than in ten days prior to day of carrying out.

2.5. The notification 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 notification on its carrying out.

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 ten working days, and concerning small business entities - two working days.

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

2.9. The state supervision (control) can be exercised in a complex by several state supervision bodies (control) if their powers on implementation or participation in complex actions are provided by the law. Such events are held according to the joint decision of heads of relevant organs of the state supervision (control).

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

3.1. Officials of control facilities when carrying out implementation of 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 carrying out economic activity on production of medicines, wholesale, retail trade by medicines, for inspection and clarification of the questions which are directly connected with check;

get acquainted with 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 lead to 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 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 meet him;

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 checks, stipulated by the legislation;

the official of control facility did not provide the copy of documents, stipulated by the legislation or if the provided documents do not meet the requirements of the legislation.

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

4.1. Officials who perform 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 procedure of the state supervision (control), stipulated by 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 there will be the performed check, subject of check and surname, names and middle name of officials which will perform.

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 noted in it.

5.4. Before conducting check officials of control facility shall show to the head of the subject of housekeeping or person authorized by it the certificate 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 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.

Noted data are certified by the signature of the official of control facility.

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

5.8. 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:

5.8.1. On production of medicines:

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

the technical and production schedules of production of medicines approved by the producer, or documents equated to them by MZ: the file of production site, production compounding with the corresponding technological and other instructions, with observance of requirements of the operating State Pharmacopoeia of Ukraine and other normative and technical documents, the analytical regulating documentation (pharmacopoeian Article, specifications) developed according to the regulating documents, standards existing in pharmaceutical industry which establish requirements to medicine, its packaging, conditions and storage durations and medicine methods of quality control;

staff list of the subject of housekeeping and service records of workers;

the documents confirming legal relationship of workers with the subject of housekeeping (orders on appointment, employment contracts);

documents on vocational education and advanced training of workers who directly are engaged in production of medicines;

the documents confirming availability and effective functioning of pharmaceutical system of quality assurance of medicines which are made;

documentation of rather physical examination and periodic surveys of workers (personal medical cards);

the documents confirming accomplishment and observance of sanitary and hygienic requirements.

5.8.2. On wholesale and retail trade:

constituent documents of the subject of housekeeping;

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

the document confirming removal of the room of pharmaceutical institution from housing stock;

original of the license and copy of the license;

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