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

of March 3, 2009 No. 44/27

About approval of Licensed conditions of implementation of 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 N 1698 "About approval of the list of bodies of licensing" we ORDER:

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. Establish:

2.1. The licenses granted before entry into force of Licensed conditions are effective until the end of the term for which they were issued.

2.2. Paragraphs of the seventh and eighth of subitem 2.4.3 and paragraph two of subitem 2.4.19 of Item 2.4 of chapter 2 of the Section II of Licensed conditions become effective from 01.01.2010.

3. To department of licensing of the State committee of Ukraine concerning regulatory policy and entrepreneurship (Ivanchenko O. B.), to Management of licensing and control of observance of licensed conditions of the State inspectorate for quality control of medicines (Zbrozhek S. I.) in accordance with the established procedure to provide submissions of this order on state registration in the Ministry of Justice of Ukraine.

4. To the head of department of licensing and control of observance of licensed conditions of the State inspectorate for quality control of medicines (Zbrozhek S. I.) provide the publication of this order in mass media.

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

Approved by the Order of the State committee of Ukraine concerning regulatory policy and entrepreneurship, the State inspectorate for quality control of medicines of March 3, 2009 No. 44/27

Licensed conditions of implementation of 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", determine Licensed conditions of implementation of 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 pattern of ownership which carry out the economic activity connected with production of medicines, wholesale, retail trade by medicines and also on physical persons - the subjects of business activity performing activities in the specified industry (further - the subject of managing).

If the subject of economy 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.

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

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

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 them;

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 is created at the companies, in organizations and the organizations for retail trade by 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 for trade in finished pharmaceutical products;

production of medicines - individual production in the conditions of drugstore of medicines according to recipes of doctors and by request (requirement) of treatment-and-prophylactic institutions;

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 by request (requirement) of treatment-and-prophylactic institutions;

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 processes of packing, packaging and/or marking, quality control in production process, and also trade (realization) in self-produced products;

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

the distributor - the subject of managing who is engaged in wholesale trade in 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 - from part of the building or its compartment which has separate entrance outside own lighting, ventilation (natural or mechanical) and it is 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 economic activity which 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;

the low-quality (substandard) medicinal sredstvapreparata made by the legal producer with the correct marking, but which in the absence of proper conditions of production, transportation and/or storages do not meet the requirements established by regulating documents;

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 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 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 further 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 observation 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 purposely 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 is subject to licensing:

production of medicines;

wholesale trade by medicines;

retail trade by medicines.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info