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The document ceased to be valid since June 13, 2017 according to Item 1 of the Order of the Ministry of Health of Ukraine of May 11, 2017 No. 506

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Ministry of Justice of Ukraine

December 7, 2011

No. 1420/20158

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 31, 2011 No. 723

About approval of Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines

(as amended on 22-12-2014)

According to Articles 5, 6, 8 Laws of Ukraine "About licensing of certain types of economic activity", the resolution of the Cabinet of Ministers of Ukraine of 14.11.2000 No. 1698 "About approval of the list of bodies of licensing" (with changes) PRIKAZYVAYU:

1. Approve Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines (further - Licensed conditions) which are applied.

2. Determine that the paragraph third Item 3 of the Section I and the Section V of Licensed conditions void in 1 year from the date of entry into force of this order.

3. The subjects of managing who obtained licenses for implementation of economic activity on production of medicines, wholesale, retail trade by medicines before entry into force of this order, shall within six months from the date of entry into force of this order bring the activities into accord with Licensed conditions.

4. Declare invalid the order of the State inspectorate for quality control of medicines of the Ministry of Health of Ukraine of September 21, 2010 No. 340 "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 on October 25, 2010 for No. 968/18263.

5. To the First Deputy Chairman of Public service of Ukraine on medicines Demchenko I. B. in accordance with the established procedure to provide provision of this order on state registration in the Ministry of Justice of Ukraine and the publication of this order in printing mass media.

6. To impose control over the implementation of the order on the First Deputy Minister Moiseenko R. O. and the First Deputy Chairman of Public service of Ukraine on medicines Demchenko I. B.

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

Minister

O. V. Anishchenko

Approved by the Order of the Ministry of Health of Ukraine of October 31, 2011 No. 723

Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade by medicines

I. General provisions

1.1. These Licensed conditions are developed according to the Laws of Ukraine of "Basis of the legislation of Ukraine about health care", "About medicines", "About licensing of certain types of economic activity" and establish qualification, organizational, production and other requirements for implementation of economic activity on production of medicines, wholesale, retail trade by medicines.

1.2. Action of these Licensed conditions extends to all subjects of managing - registered in the procedure for legal entities established by the legislation irrespective of their form of business and patterns of ownership performing the economic activity connected with production of medicines, wholesale, retail trade by medicines and also on physical persons of the entrepreneurs performing economic activity in the specified sphere (further the subject of managing).

If the subject of managing performs the specified type of economic activity not in full, and partially, Licensed conditions extend to the subject of managing in part which establishes requirements to implementation of the economic activity specified in the license.

In the license the type of economic activity which is performed by the subject of managing is specified fully or partially.

1.3. Terms which are used in these Licensed conditions have such values:

active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - AFI) - any substance or mix of substances which is held for use in production of medicine and during this use becomes its active ingredient. Such substances have pharmacological or other direct action on human body; as a part of ready forms of medicines they are applied to treatment, diagnostics or prevention of disease, to change of condition, structures or physiologic functions of organism, to leaving, processing and relief of symptoms;

drugstore - institution of health care which main objective is providing the population, institutions of health care, the companies, organizations and organizations with medicines by implementation of retail trade;

pharmaceutical booth - structural division of drugstore which main objective is providing the population with medicines by implementation of retail trade with finished pharmaceutical products which are released without recipes of the doctor;

pharmaceutical Item - structural division of drugstore which is created in treatment-and-prophylactic institutions which main objective is providing the population with medicines by implementation of retail trade with finished pharmaceutical products;

pharmaceutical warehouse (base) - institution of health care which main objective consists in ensuring wholesale or retail trade with medicines of other subjects, institutions of health care and producers of medicines, by implementation of wholesale trade by it;

pharmaceutical institutions - pharmaceutical warehouses (bases), drugstores and their structural divisions;

the separated room - the isolated part of the internal building or its department, having separate entrance from the room of the building (the hall, corridor, the platform) and separated other amount of construction (building) by walls and overlappings;

producer of medicines - the subject of managing which is performing at least one of production phases of medicines and having the license for production of medicines;

production (production) of medicines in the conditions of drugstore - individual production of medicines according to recipes of doctors, to order (requirement) of treatment-and-prophylactic institutions and production of intra pharmaceutical procurement;

production of medicines (industrial) - the activities connected with serial release of medicines which include everything or at least one of stages of engineering procedure, including purchase of materials and products, packing, packaging and/or marking, storage, the corresponding control, issue of permission to release (realization), and also wholesale trade (distribution) by self-produced products;

intra pharmaceutical procurement - the concentrated solutions, semifinished products which use for production of ex-temporal medicines, the ex-temporal medicines made for emergency on often repeated to copy-books;

distribution - any activities connected with purchase, storage, deliveries, transportation and import/export of medicines, except for their sales directly to citizens for their private consumption;

the distributor - the subject of managing performing the related activity concerning distribution of medicines;

the zone - part of the room, the square which is used for separate stage of engineering procedure and has clear visual boundary;

the isolated room - the part of the building or its department having separate entrance outside, lighting, ventilation (natural or mechanical), and separated other amount of construction (building) by walls and overlappings;

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

the license - the document of the state sample certifying the right of the licensee to implementation of the type of economic activity specified in it during certain term in case of its establishment by the Cabinet of Ministers of Ukraine on condition of accomplishment of these Licensed conditions;

methods of quality control (further - MKK) - the regulating documentation approved in accordance with the established procedure which determines techniques of quality control of medicines establishes qualitative and quantitative indices of medicine and their admissible limits, requirements to packaging, marking, storage conditions, transportation, expiration date which were approved in case of state registration (re-registration) of medicine;

the place of acceptance of products - production zone / room in which the workplace of the specialist for carrying out incoming inspection of quality of medicines in case of their receipt of managing by the subject is equipped;

proper production practice (Good Manufacturing Practice (GMP)) - part of system of quality assurance which guarantees that medicines are constantly made and controlled according to the quality standards corresponding to their appointment and also according to requirements of the registration file or the specification of these products;

proper practice of distribution (GDP) - set of requirements and rules to wholesale trade by medicines which observance provides quality of medicines in the course of wholesale trade at all its stages;

low-quality medicines - medicines which quality does not meet the requirements of regulating documents. Medicines expired also belong to low-quality medicines; which underwent the mechanical, chemical, physical, biological or other impact excluding opportunity their further use;

wholesale trade by medicines - activities for acquisition of medicines at producers of the medicines or other subjects of managing having the corresponding license, to storage, transportation and sale of medicines from pharmaceutical warehouses (bases) to other subjects of wholesale or retail trade by medicines who obtained on it the corresponding licenses, to both directly treatment-and-prophylactic institutions and producers of medicines;

realization - activities of subjects of managing for sales of goods (works, services);

the recipe - the medical document in type (form) of the instruction to drugstore, pharmaceutical Item which is written out by the specialist on the prescription form having the right to it according to the legislation based on which production and/or leave of medicine from drugstores and pharmaceutical Items on established to rules is performed. The forms of prescription forms given in appendix 1 to the Rules of writing out of recipes and requirements orders of medicines and products of medical appointment approved by the order of the Ministry of Health of Ukraine of 19.07.2005 No. 360, registered in the Ministry of Justice of Ukraine 20.07.2005 for No. 782/11062, and in appendix 8 to the Procedure for the address of drugs, psychotropic substances and precursors in institutions of health care of Ukraine approved by the order of the Ministry of Health of Ukraine of 21.01.2010 No. 11, registered in the Ministry of Justice of Ukraine 27.05.2010 for No. 347/17642;

prescription medicine - medicine which is released from drugstores and pharmaceutical Items according to the recipe of the doctor;

retail trade by medicines - activities for acquisition, storage and sale of finished pharmaceutical products through drugstore and its structural divisions (including the drugs made (made) in the conditions of drugstore) directly to citizens for their private consumption, to health care institutions (except pharmaceutical institutions) and also to the companies, organizations and the organizations without the right of their subsequent resale;

the structural division of drugstore - pharmaceutical Item which is created and functions together with drugstore according to the legislation, including these Licensed conditions;

The authorized person of the subject of managing (further - the Authorized person):

for the subjects of managing performing wholesale, retail trade by medicines - the specialist with complete higher pharmaceutical education and length of service in at least 2 years (except the case provided by subitem 3.5.7 of Item 3.5 of the Section III of these Licensed conditions) to whom the subject of managing assigns obligations concerning functioning of system of quality assurance of medicines in case of their wholesale and retail trade and registrations of conclusion of incoming inspection of quality of medicines;

For the subjects of managing performing wholesale, retail trade by medicines - the person having the diploma about pharmaceutical formation of educational institutions III-IV of levels of accreditation and the certificate on assignment (confirmation) of rank of the specialist pharmacist or certified for this specialty with assignment (confirmation) of qualification category also has length of service in "Pharmacy" at least two years (except for the case provided by subitem 3.5.7 of Item 3.5 of the Section III of these Licensed conditions) to which the subject of managing assigns obligations on functioning of system of quality assurance of medicines in case of their wholesale and retail trade;

counterfeited medicine - medicine which is purposely marked nonidentically (not in compliance) to the data (to one or several of them) about medicine with the corresponding name entered in the State register of medicines of Ukraine, and also medicine which is purposely counterfeited by different way and does not correspond to data (to one or several of them), including to structure, about medicine with the corresponding name entered in the State register of medicines of Ukraine.

1.4. According to the legislation are subject to licensing:

production of medicines;

wholesale trade by medicines;

retail trade by medicines.

1.5. Licensing of the specified type of economic activity is means of the regulating impact of the state on activities of subjects of managing and control of observance by the licensee of requirements of the legislation in the field of production of medicines, wholesale, retail trade by medicines.

1.6. Documents acceptance which move for receipt of the license issue, renewal, cancellation of licenses, issue of duplicates of licenses, conducting licensed cases and licensed registers, control within the competence of observance by licensees of these Licensed conditions, issue of orders about elimination of violations of these Licensed conditions are carried out by Public service of Ukraine on medicines (further - Gosleksluzhba of Ukraine).

1.7. For receipt of the license for the activities specified in Item 1.4 of this Section in full or partially the subject of managing submits to Gosleksluzhbu of Ukraine the application in the form given in appendix 1 to these Licensed conditions in which the code on EGRPOU is specified, in particular, either registration number of accounting card of the taxpayer, or series and passport number (for physical persons which on the religious beliefs refuse adoption of registration number of accounting card of the taxpayer and officially reported about it in relevant organ of the State Tax Service and have mark in the passport). The specified application is submitted personally or through the body authorized by it or person.

In case of availability at the applicant of the isolated structural divisions which will perform economic activity based on the obtained license their places of implementation of economic activity are specified in the statement.

1.8. Documents, the stipulated in Article 10 Laws of Ukraine "About licensing of certain types of economic activity" are enclosed to the application.

Data signed by the applicant - the subject of managing about availability of material and technical resources and qualified personnel move in the forms given in appendices 9-11.

The statement for licensing and the documents which are attached to it are accepted under the list of documents, enclosed to the application on receipt of the license which form is given in appendix 2 to these Licensed conditions and which copy is issued to the applicant with mark about date of documents acceptance by Gosleksluzhboy of Ukraine and the signature of the authorized officer.

All documents filed by the applicant are created in separate case.

1.9. The statement for licensing remains without consideration if:

the application is submitted (signed) by person which does not have on it powers;

documents are processed with violation of requirements of article 10 of the Law of Ukraine "About licensing of certain types of economic activity".

Gosleksluzhboy of Ukraine in writing with indication of the bases of leaving of the statement without consideration in the terms provided for licensing is reported to the applicant about leaving of the statement for licensing without consideration.

1.10. After elimination of the reasons which were the basis for decision making about leaving of the statement for licensing without consideration the applicant can repeatedly submit the application for licensing.

1.11. The Gosleksluzhba of Ukraine makes the decision on licensing or on refusal in its issue no later than ten working days from receipt date of the statement for licensing and the documents which are enclosed to the application in time.

The basis for licensing for carrying out economic activity on wholesale, retail trade by medicines is availability of material and technical resources, qualified personnel (appendices 9-11) which compliance to the established requirements and declared in the documents filed by the applicant for receipt of the license to characteristics is subject to obligatory check before licensing within the terms provided for licensing at the venue of activities by Gosleksluzhboy of Ukraine or its territorial authorities - public services on medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol.

The basis for licensing for production of medicines is availability of the corresponding material and technical resources, qualified personnel, and also conditions on control of quality of medicines which will be made. Compliance of material and technical resources, qualification of personnel, and also conditions on control of quality of medicines which will be made to the established requirements and declared in the documents filed by the applicant for receipt of the license to characteristics is subject to obligatory check before licensing within the terms provided for licensing at the venue of activities Gosleksluzhboy of Ukraine according to the procedure, certain MZ of Ukraine.

1.12. The message on decision making on licensing or on refusal in licensing is sent issued) to the applicant in writing within three working days from acceptance date of the relevant decision.

1.13. The bases for decision making about refusal in licensing are:

unauthenticity of data in the documents filed by the applicant for receipt of the license;

discrepancy of the applicant according to the filed documents to these Licensed conditions established for the sake of appearances economic activity specified in the statement for licensing.

In case of refusal in licensing based on detection of doubtful data in the documents filed by the applicant about licensing, the subject of managing can submit to Gosleksluzhbu of Ukraine the new application for licensing not earlier than in three months from decision date about refusal in licensing.

In case of refusal in licensing based on discrepancy of the applicant to these Licensed conditions established for the sake of appearances economic activity, specified in the statement for licensing, the subject of managing can submit to Gosleksluzhbu of Ukraine the new application for licensing after elimination of the reasons which became the basis for refusal in licensing.

1.14. Compliance of the subject of managing to these Licensed conditions is established by body of licensing based on the documents filed to Gosleksluzhbu of Ukraine which are enclosed to the application for licensing. The body of licensing cannot charge to other persons to determine possibility of subjects of managing to satisfy these Licensed conditions according to the filed documents.

1.15. Licenses for production of medicines, wholesale, retail trade by medicines, are drawn up on the forms of single sample approved by the resolution of the Cabinet of Ministers of Ukraine of 20.11.2000 No. 1719 "About introduction of the license of single sample for certain types of economic activity". The license is signed by the head Gosleksluzhby of Ukraine or his deputy and certified by seal this body.

1.16. The license is drawn up not later than three working days from the date of receipt of the document confirming introduction of payment for licensing.

If the applicant within thirty calendar days from the date of the direction to him of the message on decision making on licensing did not file the document confirming introduction of payment for licensing or did not address in Gosleksluzhbu of Ukraine for receipt of the drawn-up license, then Gosleksluzhba of Ukraine has the right to cancel the decision on licensing or to make the decision on recognition of invalid such license.

1.17. The license for production of medicines is granted taking into account the list of dosage forms and special conditions of carrying out economic activity which are specified in stand-alone programs to the license for production of medicines. Appendix to the license for carrying out economic activity on production of medicines (appendix 12) is drawn up for each specific location of the subject of managing and/or its isolated structural division (in the presence) depending on the place of implementation of production of medicines. Change of the list of the dosage forms permited to production to the licensee and also conditions of carrying out activities for production of medicines is the change connected with carrying out economic activity by the licensee of certain type.

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