RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of November 30, 2016 No. 929

About approval of Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients)

According to Item 7, to paragraph one of part two of article 9 of the Law of Ukraine "About licensing of types of economic activity" the Cabinet of Ministers of Ukraine decides 10 parts one of Article:

1. Approve Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) which are applied.

2. Determine that:

the term during which subjects of managing which obtained the license for implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) before entry into force of this resolution, shall bring the activities into accord with the Licensed conditions approved by this resolution constitutes two months from the date of entry into force of this resolution (except the case specified in paragraph three of this Item);

the term during which subjects of managing which obtained the license for implementation of economic activity on retail trade by medicines before entry into force of this resolution shall bring the activities into accord with the paragraph the fifth Item 165 of the Licensed conditions approved by this resolution constitutes one year from the date of entry into force of this resolution.

2-1. Determine that for action of warlike situation:

ensuring compliance with the legislation on licensing of types of economic activity during import to the territory of Ukraine, storage, quality control, issue of permission to release (realization) of series of medicines which are bought by person authorized on implementation of purchases in the field of health care is performed by involvement of subjects of managing who have the license for implementation of economic activity on import of medicines;

ensuring compliance with the legislation on licensing of types of economic activity in storage time, transportations of the medicines which are purchased by person authorized on implementation of purchases in the field of health care, legislations on quality control of medicines during wholesale trade is performed by involvement of subjects of managing who have the license for implementation of economic activity on wholesale trade by medicines.

3. This resolution becomes effective from the date of its publication, except Items 194 - 200, 258, 259, 265 Licensed conditions approved by this resolution which become effective since March 1, 2018.

Approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929

Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients)

General part

1. These Licensed conditions establish the exhaustive list of the requirements obligatory for accomplishment by the licensee, and the exhaustive list of the documents enclosed to the application for receipt of the license for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, import of medicines (except active pharmaceutical ingredients).

2. Action of these Licensed conditions extends to all subjects of managing, in particular on registered in the procedure for legal entities established by the legislation, irrespective of their form of business and pattern of ownership, physical persons entrepreneurs who perform economic activity on production of medicines, wholesale, retail trade by medicines, import of medicines (except active pharmaceutical ingredients) (further - the subject of managing).

The licensee shall fulfill requirements of these Licensed conditions, and the license applicant for its obtaining - to correspond to these Licensed conditions.

Action of these Licensed conditions does not extend to subjects of managing who perform economic activity on import of medicines (except active pharmaceutical ingredients) according to the Laws of Ukraine "About the humanitarian assistance", "About charity and charitable organizations" and "About accomplishment of programs of Global fund for fight against AIDS, tuberculosis and malaria in Ukraine".

3. The terms used in these Licensed conditions have the following values:

active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - active pharmaceutical ingredient) - any substance or mix of substances, held for use in production of medicine and in case of this use becomes its active ingredient. Such substances have pharmacological or other direct impact 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 physiological functions of organism, to leaving, processing and relief of symptoms;

drugstore - healthcare institution which main objective is providing the population, healthcare institutions, companies, organizations and organizations with medicines;

the pharmaceutical Item - structural division of drugstore which is created in treatment and prevention facilities and functions together with drugstore according to these Licensed conditions which main objective is providing the population with medicines by implementation of retail trade;

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

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

the certain room - the isolated part of internal structure or its department, having separate entrance from the room of the building (the hall, corridor, the platform) are also separated by walls and overlappings;

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 (production) of medicines in the conditions of drugstore individual production of medicines according to recipes of doctors, by request of treatment and prevention facilities and production of intra pharmaceutical procurement, concentrates, semifinished products, and also the medicines made in inventory;

production of medicines (industrial) - the activities connected with serial release of medicines which include everything or at least one of transactions on engineering procedure, quality control, issue of permission to release, and also purchase of materials and products, storage, wholesale trade (distribution) of self-produced medicines;

intra pharmaceutical procurement - the concentrated solutions, semifinished products used for production of ex-temporal medicines, the ex-temporal medicines made in inventory on often repeating copy-books;

distribution (wholesale distribution) of medicines - any activities connected with obtaining, storage, deliveries, transportation and import/export of medicines, except for their sales directly to citizens for private consumption. These activities are performed together with producers or their representatives, importers, other companies on wholesale and/or retail trade by medicines, treatment and prevention facilities;

the distributor - the subject of managing performing the related activity on distribution (wholesale distribution) of medicines;

electronic retail trade by medicines - retail trade by medicines with use of information and telecommunication systems by remote method which includes acceptance, completing, storage, delivery of orders for medicines and leave of medicines to final consumers;

policy tools of economic activity - the building (room), the equipment which are in property or use of the licensee for the organization of implementation of the activities which are subject to licensing;

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

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

import of medicines (except active pharmaceutical ingredients) - the activities connected with import to the territory of Ukraine of the registered medicines for the purpose of their further realization, wholesale trade, non-paid supply in case of their purchase by person authorized on implementation of purchases in the field of health care, for the list approved by the Cabinet of Ministers of Ukraine, on condition of confirmation of purpose of import to the territory of Ukraine of such medicines according to the procedure, determined by the Cabinet of Ministers of Ukraine, or use in production of finished pharmaceutical products or medical practice, including storage, quality control, issue of permission to release (realization) of series of the medicine specified in appendix to the license;

the final consumer (consumer) - physical person which acquires orders, uses or has intention to acquire or order medicine for the personal needs which are directly not connected with business activity or fulfillment of duties of hired employee;

the importer of medicines (further - the importer) - the subject of managing registered in Ukraine, in particular the producer or person representing producer of medicines, performing economic activity on import of medicines also has the import license of medicines;

methods of quality control - 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, transportations, expiration date which were approved during state registration (re-registration) of medicine;

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

proper production practice - part of quality management process which guarantees that medicines are constantly made and controlled according to the quality standards which correspond to their appointment, and also according to requirements of the registration file, the file of the researched medicine for clinical testing or the specification for these products;

proper practice of distribution - part of process of quality assurance which guarantees that quality of medicines remains on all sites of supply chain from the producer to drugstore or treatment and prevention facility;

low-quality medicines - medicines which quality does not conform to requirements of regulating documents. Medicines expired also belong to low-quality medicines; undergone to mechanical, chemical, physical, biological or other impact that makes impossible their further use;

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, transportation and sale of medicines from pharmaceutical warehouses (bases) to other subjects of wholesale or retail trade by medicines which obtained the corresponding licenses, to producers of medicines, it is direct to treatment and prevention facilities or legal entities whose structural divisions are treatment and prevention facilities, and also to person authorized on implementation of purchases in the field of health care;

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

the recipe - the medical document which is written out by the rules approved by the Ministry of Health based on which production and/or leave of medicine from drugstores and their structural divisions is performed;

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 the proprietary medicines made (made) in the conditions of drugstore, through drugstore and its structural divisions directly to citizens for private consumption, to healthcare 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 which is formed and functions together with drugstore according to these Licensed conditions;

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

for subjects of managing which perform wholesale trade by medicines, person having the document on the higher education not below the second (master) level in "Pharmacy, industrial pharmacy" the certificate of the specialist pharmacist issued by organization of post-qualifying education, or the certificate of assignment (confirmation) of the corresponding qualification category and having length of service in "Pharmacy, industrial pharmacy" at least two years to which the subject of managing assigns obligations on functioning of the quality system of medicines during wholesale trade;

for subjects of managing which perform retail trade by medicines - person having the document on the higher education not below the second (master) level in "Pharmacy, industrial pharmacy", the certificate of the specialist pharmacist issued by organization of post-qualifying education, or the certificate of assignment (confirmation) of the corresponding qualification category and having length of service in "Pharmacy, industrial pharmacy" at least two years (except case, the stipulated in Item 165 presents of Licensed conditions) to which the subject of managing assigns obligations on functioning of the quality system of medicines during wholesale and retail trade;

for the subjects of managing performing production of medicines (industrial) - the specialist having the higher education not below the second (master) level in "Pharmacy, industrial pharmacy", "Chemical technologies and engineering", "Biotechnologies and bioengineering", "Biomedical engineering", "Chemistry", "Biology" and length of service in at least two years in the field of production, quality control or creation of medicines to whom the subject of managing assigns obligations on functioning of the pharmaceutical quality system during production of medicines and provision of permission to release (realization) of medicines;

for the subjects of managing performing import of medicines - the specialist having the higher education not below the second (master) level in "Pharmacy, industrial pharmacy", "Chemical technologies and engineering", "Biotechnologies and bioengineering", "Biomedical engineering", "Chemistry", "Biology" and length of service in at least two years in the field of production, quality control, wholesale trade or development of medicines to whom the subject of managing assigns obligations on functioning of the pharmaceutical quality system during import (import) of medicines to the territory of Ukraine and provision of permission to release (realization) of the imported medicines.

Other terms are used in the value given in the Laws of Ukraine "About medicines" and "About licensing of types of economic activity".

4. Implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) is performed through:

for production of medicines (industrial) - production site with indication of the list of dosage forms, the warehouse area (the room for storage, warehouse), quality control zone, zone of implementation of issue of permission to release of medicines;

for production (production) of medicines in the conditions of drugstore - drugstore;

for wholesale trade by medicines - pharmaceutical warehouse (base);

for retail trade by medicines - drugstore, pharmaceutical Item;

for electronic retail trade by medicines - drugstore, pharmaceutical Item;

for import of medicines (except active pharmaceutical ingredients) - the warehouse area (the room for storage, warehouse), quality control zone, zone of implementation of issue of permission to release (realization) of series of medicine.

5. Documents are filed to body of licensing at the choice of the licensee or the license applicant by the method determined by part one of article 10 of the Law of Ukraine "About licensing of types of economic activity" and these Licensed conditions.

6. For receipt of the license in full or partially on activities:

on production (production) of medicines in the conditions of drugstore, wholesale trade by medicines, retail trade by medicines the subject of managing submits to body of licensing the application in the form given in appendix 1;

on production of medicines (industrial) the subject of managing submits to body of licensing the application in the form given in appendix 2;

on import of medicines (except active pharmaceutical ingredients) the subject of managing submits to body of licensing the application in the form given in appendix 3.

Places of implementation of type of economic activity which is licensed are specified in the statement.

7. Are enclosed to the application for receipt of the license:

1) supporting documents in each place of implementation of type of the economic activity which is subject to licensing:

for production of medicines (industrial) - the copy of the file of the production site approved by subject of managing in paper or electronically on electronic media of information;

for production (production) of medicines in the conditions of data drugstore signed by the applicant subject of managing about availability of material and technical resources and qualification level of the workers necessary for implementation of economic activity on production (production) of medicines in the conditions of drugstore, in the form given in appendix 4;

for retail trade by medicines - data on availability of material and technical resources and the qualified personnel necessary for implementation of economic activity on retail trade by medicines in the form given in appendix 5;

for electronic retail trade by medicines - data on availability of material and technical resources and the qualified personnel necessary for implementation of economic activity on electronic retail trade by medicines in form according to appendix 24, the copy of the contract with the operator of mail service on implementation of delivery of medicines to the final consumer certified by the licensee (in case of attraction on a contract basis operators of mail service);

for wholesale trade by medicines - data on availability of material and technical resources and the qualified personnel necessary for implementation of economic activity on wholesale trade by medicines, in the form given in appendix 6;

for import of medicines (except active pharmaceutical ingredients) - the copy of the file of the importer approved as the subject of managing in the form given in appendix 7, in paper or electronic form on electronic media of information;

2) the passport copy of the license applicant with mark of the relevant monitoring body about refusal on the religious beliefs of adoption of registration number of accounting card of the taxpayer (moves only physical persons entrepreneurs who on the religious beliefs refuse adoption of registration number of accounting card of the taxpayer and reported about it to the relevant monitoring body);

3) information on confirmation of lack of control of activities of the subject of managing in the value given in article 1 of the Law of Ukraine "About protection of the economic competition", residents of the states performing the armed aggression against Ukraine in the value given in article 1 of the Law of Ukraine "About defense of Ukraine". Such information moves in any form with observance of requirements of Item of 9 presents of Licensed conditions.

8. In case of document creation, constituted by the license applicant, the licensee on paper, together with the corresponding statement and supporting documents the license applicant or the licensee gives two copies of the list of documents to body of licensing (appendix 8).

All documents submitted by the license applicant are created in separate case.

9. The documents constituted by the license applicant and the licensee according to these Licensed conditions are stated in state language and signed by the license applicant, the licensee or person, the representative to represent the legal entity in legal relationship with the third parties, or person having the right to make actions on behalf of the legal entity without power of attorney, including to sign agreements and data on availability of restrictions concerning representation on behalf of the legal entity.

10. The body of licensing makes the decision on licensing or on refusal in its issue no later than ten working days from the date of obtaining by body of licensing of the statement for receipt of the license and the documents enclosed to the application in time.

The basis for licensing for implementation of economic activity on production (production) of medicines in the conditions of drugstore, wholesale, retail trade by medicines is availability of material and technical resources, qualified personnel 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, in each place of implementation of activities by body of licensing or its territorial authorities according to the procedure, determined by the Ministry of Health.

The basis for licensing for implementation of economic activity on production (production) of medicines, import of medicines (except active pharmaceutical ingredients) is availability of the corresponding material and technical resources, qualified personnel, and also conditions on quality control of medicines which will be made and/or will be imported. Compliance of material and technical resources, qualification of personnel, and also conditions on quality control of medicines which will be made and/or will be imported, 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, in each place of implementation of activities by body of licensing according to the procedure, determined by the Ministry of Health.

11. The license for production of medicines is granted taking into account the list of dosage forms in each place of implementation of economic activity and special conditions of implementation of activities which are specified in appendix to the license. Appendix to the license is its integral part and is drawn up in the form given in appendix 9. Information on appendix to the license for implementation of economic activity on production of medicines is entered in the licensed register.

12. The import license of medicines (except active pharmaceutical ingredients) is granted together with appendix in which places of implementation of activities of the licensee, the list of the medicines permited to import to the licensee and special conditions of implementation of activities are specified. Appendix to the import license of medicines (except active pharmaceutical ingredients) is its integral part and is drawn up in the form given in appendix 10. Information on appendix to the license for implementation of economic activity on import of medicines (except active pharmaceutical ingredients) is entered in the licensed register.

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