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 carrying out economic activity on production of medicines, wholesale, retail trade by medicines

According to Articles 5, of 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) I ORDER:

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

2. Determine that the licenses granted to the introduction in action of Licensed conditions are effective until the end of the term for which they were issued.

3. 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 the publication of this order in printing mass media.

4. 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.

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

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. 340

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

I. General provisions

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

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 which carry out the economic activity connected with production of medicines, wholesale, retail trade by medicines and also on physical persons - entrepreneurs who perform activities in the specified industry (further - the subject of managing).

If the subject of managing conducts 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 conducting the economic activity specified in the license.

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

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

drugstore - institution of health care which main task 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 task 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 task is providing the population with medicines by implementation of retail trade with finished pharmaceutical products;

pharmaceutical warehouse (base) - institution of health care which main task 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 them;

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

production of medicines - individual production in the conditions of drugstore of medicines according to recipes of doctors and to order (upon the demand of) treatment-and-prophylactic institutions;

producer of medicines - subject of managing which performs at least one of production phases of medicines and has the license for production of medicines;

production of medicines in conditions the aptekideyatelnost connected with serial release of medicines in the form of semifinished products and intra pharmaceutical procurement and also serial production of medicines to order (upon the demand of) treatment-and-prophylactic institutions;

production of medicines is industrial - the activities connected with serial release of medicines which include everything or at least one of stages of engineering procedure, and also wholesale trade (realization) by self-produced products;

distribution - any activities connected with purchase, storage, deliveries, transportation and import/export, except for their leaves directly to the population;

the distributor - the subject of managing who performs activities for 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 - part of the building or its compartment which has separate entrance outside, own 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 carrying out certain type of economic activity who is subject to licensing;

the place of acceptance of products - production zone 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 (GMP) - set of organizational engineering requirements and rules which is part of system of quality assurance and guarantees that products are constantly made and controlled on the quality standards which answer its appointment, and according to requirements of the registration file;

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 (substandard) medicinal sredstvalekarstvenny means which do not meet the requirements of regulating documents;

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 and sale of medicines from pharmaceutical warehouses (bases) to other subjects of wholesale or retail trade by medicines which 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 who has the right to it according to the legislation based on which production and/or leave of medicine from drugstores and pharmaceutical Items on statutory rules is performed. Forms of prescription forms affirm in accordance with the established procedure;

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 (developed) 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 or pharmaceutical booth which is created and functions together with drugstore according to the legislation and these Licensed conditions;

joint products - goods which have the right to acquire and sell pharmaceutical institutions and their structural divisions according to the list which determines MZ;

traditional medicines - medicines, first of all plant origin to which state registration the simplified procedure according to the procedure is allowed the established MZ, and also to production of which are not applied separate Items of these Licensed conditions. Traditional medicines are provided for oral, outside or inhalation application without supervision of the doctor for the purpose of diagnostics, treatment without instruction or the recipe, in certain concentration and dosing if there is documentary confirmation that such medicine was applied at least 30 years in the world and at least 10 years in Ukraine, and also there is sufficient amount of data on safety of its application in case of usual conditions and its efficiency is proved;

The authorized person - the specialist with complete higher pharmaceutical education and length of service in at least 2 years on whom the subject of managing confers responsibility for functioning of system of quality assurance of medicines in case of their production, wholesale and retail trade and provision of permission to trade in medicines;

counterfeited medicines - medicines which are intentionally incorrectly marked concerning identity and the name of the producer. Can be counterfeited both the original, and reproduced medicines, they may contain ingredients in the corresponding or inappropriate structure, can be without active ingredients, with their insufficient quantity or in deceptive package.

Contents of other terms which are applied in these Licensed conditions are determined by the current legislation.

4. According to the legislation are subject to licensing:

production of medicines;

wholesale trade by medicines;

retail trade by medicines.

5. Licensing of the specified type of economic activity is means of the regulating influence of the state on activities of subjects of managing and control of observance by the licensee of requirements of the legislation to the pharmaceutical activities connected with production of medicines, wholesale, retail trade by medicines.

6. Adoption of documents which are filed for receipt of the license issue, renewal and cancellation of licenses, issue of duplicates of licenses, conducting licensed cases and licensed registers, control within the competence of observance by licensees of Licensed conditions, issue of orders about elimination of violations of Licensed conditions are carried out by the State inspectorate for quality control of medicines of the Ministry of Health of Ukraine (farther than Goslekinspektion MZ).

7. The license is the single document of allowing nature which grants the right to implementation of economic activity on production of medicines, to wholesale, retail trade by medicines and carrying out the specified types of activity in all territory of Ukraine allows.

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