(2024-10-07-ны өдрийн орчуулга)                                               Unofficial translation

LAW OF MONGOLIA

June 5, 2024         State Palace, Ulaanbaatar City

 ON VETERINARY MEDICINES AND FEED ADDITIVES

CHAPTER ONE
GENERAL PROVISIONS

Article 1.Purpose of the law

1.1.The purpose of this Law is to regulate the relations related to approvals, registration, production, certification, trade, supply, usage, and control of veterinary medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, feed additives, and diagnostic devices.

Article 2.Legislation on veterinary medicines and feed additives

2.1.The legislation on veterinary medicines and feed additives shall consist of the Constitution of Mongolia, the Law on the Livestock and Animal Health, the Law on Control of Circulation of Narcotic Drugs and Psychotropic Substances, the Law on Metrology, the Law on Standardization, Technical Regulations and Accreditation of Conformity Assessment, the Law on Medicines and Medical Devices, the Law on Permits, this Law and other legislative acts issued in accordance with these laws.

2.2.If an international treaty to which Mongolia is a party stipulates otherwise than this Law, the provisions of the international treaty shall prevail.

Article 3.Principles for veterinary medicines and feed additives

3.1.The following principles shall be adhered to regarding veterinary medicines (hereinafter referred to as "medicines") and feed additives:

3.1.1.to enhance transparency, openness, and accountability in the pharmaceutical sector, and strengthen the comprehensive regulatory system for medicines;

3.1.2.to ensure accessibility and sustainability of medicines and medical devices;

3.1.3.to conduct the pharmaceutical sector's activities based on research and evidence, and accurately determine development trends;

3.1.4.to maintain a skilled and professional workforce in the pharmaceutical sector;

3.1.5.to implement appropriate practices in pharmaceutical supply organizations;

3.1.6.to support the domestic production of medicines, medical devices, and feed    additives.

Article 4.Definition of the terms of the Law

4.1.The following terms used in this Law shall have the following meanings::

4.1.1."medicine" shall mean products, whether synthetic or derived from animals, plants, or minerals, with specific forms, doses, and quantities, proven through pharmacological, clinical, and other trials to prevent, diagnose, or treat diseases and conditions in livestock and animals;

4.1.2."biopreparations" shall mean what is specified in Article 4.1.8 of the Law on Medicines and Medical Devices;

4.1.3."disinfection preparations and antiseptic preparations" shall mean single or combined products with general or selective action used to inactivate or destroy microorganisms;

4.1.4."feed additives" shall mean single or multi-ingredient products used to support or regulate physiological functions in livestock and animals;

4.1.5."diagnostic devices" shall mean products with specific dosage, quantity, composition, unique characteristics, and active ingredients used for the prevention and diagnosis of diseases in livestock and animals, as well as for the analysis of livestock and animals, livestock and animal-derived raw materials, products, and environmental samples;

4.1.6."medical raw materials" shall mean what is specified in Article 4.1.36 of the Law on Medicines and Medical Devices;

4.1.7."active pharmaceutical ingredient" shall mean a biologically active compound, either single or combined, that is responsible for the therapeutic effect of the medicine;

4.1.8."medicinal supplementary substance" shall mean substances required to support the main action of the medicine, reduce adverse effects, mask or enhance taste and odor, shape the medicine, stabilize the formulation, and extend the shelf life and operational duration;

4.1.9."dispensing of medicine" shall mean what is specified in Article 3.1.12 of the Law on Health;

4.1.10."batch" shall mean the quantity produced in a single manufacturing process;

4.1.11."veterinary medicine registration" shall mean the activities related to the monitoring the quality, safety, and efficacy of medicines that have been proven to be suitable for prevention, diagnosis, and treatment based on pharmacological, toxicological, and other research, as well as the granting authorization for their use within the territory of Mongolia.

CHAPTER TWO
REGISTRATION AND CERTIFICATION OF MEDICINES, BIOPREPARATIONS, DISINFECTION PREPARATION, ANTISEPTIC PREPARATIONS, MEDICAL RAW MATERIALS, AND FEED ADDITIVES

Article 5.Veterinary medicine council and pharmacopoeia committee

5.1.A non-permanent Veterinary Medicine Council (hereinafter referred to as the "Council") with functions to support the implementation of policies to be followed by the state regarding the medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives, and a Pharmacopoeia Committee shall be established next to the state administrative body in charge of livestock and animal health issues.

5.2.Daily operations of the Council and the Pharmacopoeia Committee shall be managed by designated officials who will work within to the state administrative body in charge of livestock and animal health issues.

5.3.The Council shall exercise the following powers:

5.3.1.to register, amend, and deregister medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives;

5.3.2.to review and make decisions on the results of trials and clinical studies for newly developed medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives;

5.3.3.to develop recommendations and opinions on the selection of medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives for prevention, diagnosis, and treatment purposes;

5.3.4.to discuss the need for clinical trials for medicines, biopreparations, disinfection and antiseptic preparations imported and registered for the first time in Mongolia;

5.3.5.to develop proposals and recommendations on matters of the policy to be followed by the state regarding the medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives, and submit them to the relevant state central administrative body;

5.3.6.to discuss annual reports of supply organizations with special permit and provide conclusions and recommendations;

5.3.7.to provide professional recommendations on drug alerts, safety, and potential risks;

5.3.8.to review the annual report of the pharmacopoeia committee.

5.4.The working procedures and composition of the Council shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

5.5.The Pharmacopoeia committee shall exercise the following powers:

5.5.1.to discuss and approve national and manufacturer's pharmacopoeia monograph for veterinary medicine;

5.5.2.to assign numbers to pharmacopoeia monograph;

5.5.3.to maintain a unified registry of pharmacopoeia monograph;

5.5.4.to make amendments to and publish the pharmacopoeia;

5.5.5.to annul pharmacopoeia monograph;

5.5.6.to provide professional advice and oversight in the development of pharmacopoeia monograph.

5.6.The costs associated with the activities of the Council and the Pharmacopoeia Committee shall be reflected in the annual budget proposal of the state administrative body in charge of livestock and animal health issues.

5.7.The working procedures and composition of the Pharmacopoeia committee shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

Interpretation: The term "pharmacopoeia monograph" shall mean the mandatory document specifying the requirements, quality standards, and methods of analysis for medicines, the term "pharmacopoeia" shall mean the compilation of pharmacopoeia monographs, respectively.

Article 6.Registration of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives

6.1.The matters on the registration, amendment, and deregistration of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives in the Veterinary Medicine Registration (hereinafter referred to as the "Registration") shall be implemented by the Council.

6.2.The following medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be registered in the Registration:

6.2.1.all types of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives with purposes of prevention, diagnosis, and treatment, except those specified in Article 6.3 of this Law;

6.2.2.medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives with changes in dosage, form, packaging, composition, usage instructions, or production technology;

6.2.3.medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives provided through international loans, aid, or donations;

6.2.4.vitamins produced industrially for therapeutic dosages, and a formulation intended to support pharmaceutical treatment and for preventive purposes.

6.3.The following medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be excluded from registration:

 6.3.1.samples for registration;

 6.3.2.products used for research, analysis, or clinical trials;

 6.3.3.products intended for exhibition or trade fairs;

 6.3.4.medicinal supplementary substance;

 6.3.5.radioactive substances and their preparations;

 6.3.6.chemical reagents and all types of nutrient media;

 6.3.7.dyes for laboratory use;

 6.3.8.diagnostic devices;

 6.3.9.nutritional feed additives.

6.4.Medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be registered for a period of 5 years, specifying the country of production, manufacturer, importer, active ingredients, form, dosage, intended use, and whether it will be issued under prescription or not.

6.5.Medicines required for use during disasters or emergencies shall be registered on an expedited basis for a period of one year.

6.6.The registration of newly developed domestically produced medicines shall be determined based on test and research reports and the conclusions of the competent authority.

6.7.In order to register domestically produced medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives, the following documents shall be provided:

6.7.1.a copy of the special permit on production, the medical raw material registration certificate, an introduction to the manufacturing process, and production technology diagrams;

6.7.2.a pharmacopoeia monograph;

6.7.3.reports of the meeting of the council next to the veterinary scientific research organization in regards with the discussion of the research report;

6.7.4.test and accreditation results by the competent independent laboratories which made the test and trials;

6.7.5.detailed research reports and results on product's stability, adverse effects, interactions, toxicity or harmful effects, activity, safety, testing, and trials;

6.7.6.draft of the usage instructions.

6.8.For the registration of imported medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives, the following documents shall be submitted along with certified Mongolian translations, and submitted materials will not be returned:

6.8.1.trade agreements and power of attorneys made with the manufacturer;

6.8.2.pharmacopoeia monograph;

6.8.3.manufacturer's introduction and documents proving that the manufacture complies with international standards and quality requirements;

6.8.4.test and accreditation results from the competent independent laboratories in the country of manufacture and in the importing country;

6.8.5.published monograph on pharmaceutical and clinical trials, analysis and research results on active agent, medicinal supplementary substance, and stability quality, research results on toxicity or harmful effects, activity, composition, safety, and interactions, and labels /to be certified in Mongolian and English/;

6.8.6.instructions for use to be written according to a certified model, including details on composition, chemical properties, usage instructions, contraindications, adverse/side effects, drug interactions, dosage, storage conditions, and warnings.

Interpretation: "adverse effects of medicine" shall mean negative reactions occurring during the administration of a medicine for the purpose of prevention, diagnosis, or treatment, as specified in the instructions.

6.8.7.samples;

6.8.8.registration certificate issued by the relevant competent authority of the country of origin;

6.8.9.certificate of origin;

6.8.10.for the registration of biopreparations, in addition to the documents listed above, an evaluation report from an international accredited reference laboratory.

6.9.Medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be registered in the registry once, specifying the country of manufacture, manufacturer, dosage form, and dosage for each item.

6.10.The Council shall decide within 1 month after receiving the required documents that meet the criteria specified in this Law and within 5 working days after receiving the requests to be processed on an expedited basis.

6.11.Registration shall be updated in the following cases:

6.11.1.if the changes made in the ownership type, jurisdiction, name, address, or origin of the manufacturer of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, or feed additives;

6.11.2.if the changes made in production technology, pharmacopoeia monograph, instructions for use, or dosage.

6.12.The registration number for medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall reflect information on origin, registration year, registration validity period, international drug classification, dispensing conditions, and personal identification number.

6.13.The registration shall be extended for a period not less than the initial duration from when it was first granted, based on the findings of the relevant competent authority authorized to conduct inspection or an accredited external laboratory, provided there is no breach of the validity period, conditions, or requirements of the registration.

6.14.If the registration period for medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, or feed additives is extended, the registration number shall remain the same.

6.15.Medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be deregistered in the following cases:

6.15.1.if the supplier does not submit a request for extension to the Council at least 2 months before the registration period expires;

6.15.2.if it has been determined by the competent authority that there has been a failure to comply with veterinary treatment and services, or causes an adverse effects,  that negatively impact human and animal health, as well as the environment, and that pathogens have developed resistance to the respective medication;

6.15.3.if it has been established that the manufacturer has engaged in the fraudulent production of the medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, or feed additives.

6.16.If it is proven that the documents submitted for registration are fraudulent, the registration of the medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, or feed additives shall be invalidated.

6.17.The state administrative body in charge of livestock and animal health issues shall maintain an electronic database of the registration and information related to medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives.

6.18.The procedures for creating and managing the electronic database specified in Article 6.17 of this Law shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

6.19.The costs related to the registration of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be reflected in the annual budget proposal of the state administrative body in charge of livestock and animal health issues.

Article 7.Quality assurance of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives

7.1.In addition to the activities specified in Article 29.2 of the Law on Livestock and Animal Health, the National Veterinary Medicine Testing and Certification Laboratory shall undertake the following activities:

7.1.1.to provide recommendations related to the production, testing, and use of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives;

7.1.2.to conduct laboratory and field testing of newly introduced medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives for veterinary use;

7.1.3.to maintain, restore, validate, update, transfer, purchase, and establish reserves of standard substances to be used in laboratory monitoring, testing, and analysis, as well as strains of pathogens causing animals and livestock diseases in accordance with the relevant standards;

7.1.4.to prepare and submit quarterly reports on the testing and certification of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives to higher authorities.

7.2.When necessary, medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall be sent to internationally recognized reference laboratories for validation.

Article 8.Labeling for medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives, and its requirements

8.1.The containers, packaging, labels, and markings of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives shall include the following information:

8.1.1.trade and international names;

8.1.2.form;

8.1.3.composition, dosage, volume, quantity;

8.1.4.manufacturer's name;

8.1.5.batch number;

8.1.6.instructions for use;

8.1.7.date of manufacture and expiration date;

8.1.8.storage and transport conditions;

8.1.9.registration number;

8.1.10.pharmacopoeia monograph number.

8.2.Articles 8.1.9 and 8.1.10 of this Law shall apply only to national manufacturers.

8.3.Labels and instructions for use of medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives shall indicate the statement "For Veterinary Use Only".

8.4.Instructions for use of medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives shall be written in Mongolian and include the following information:

8.4.1.manufacturer's name and official address;

8.4.2.trade and international names;

8.4.3.composition, dosage, and volume;

8.4.4.classification and mechanism of action;

8.4.5.indications for use;

8.4.6.methods for use;

8.4.7.side effects;

8.4.8.contraindications;

8.4.9.validation date/expiration date;

8.4.10.storage conditions;

8.4.11.withdrawal period;

8.4.12.warnings.

8.5.Changes to the containers, packaging, labels, markings, and certified instructions for use of medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives shall be prohibited.

Article 9.Research and analysis of medicines, biopreparations, disinfection preparations, antiseptic preparations, feed additives, and diagnostic devices

9.1.Newly developed medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices shall be validated based on pharmacy, pharmaceutical, toxicological, and other relevant research findings.

9.2.Research reports on new medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices shall be reviewed and made a conclusion by the meeting of the Academic Council of a veterinary academic or higher educational institution.

9.3.Prior to introducing a new diagnostic device into use, the supplying organization shall conduct comparative efficacy studies through the laboratory specified in Article 29.1 of the Law on Livestock and Animal Health.

9.4.The state administrative body in charge of livestock and animal health issues shall oversee the execution of research and analysis activities through contracts and orders, and manage the implementation of the results thereto.

CHAPTER THREE

TRADE, SUPPLY, AND PERMIT OF MEDICINES, MEDICAL DEVICES, BIOPREPARATIONS, DISINFECTION PREPARATIONS, ANTISEPTIC PREPARATIONS, MEDICAL RAW MATERIALS, FEED ADDITIVES, AND DIAGNOSTIC DEVICES

Article 10.Organizations supplying medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices

10.1.Organizations involved in supplying medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices (hereinafter referred to as "supply organizations") shall adhere to the principle of providing veterinary institutions with accessible and reliable products that are registered and quality assured.

10.2.The following types of organizations shall be considered supply organizations:

  10.2.1.manufacturers;

10.2.2.supply distributors;

10.2.3.veterinary pharmacies (hereinafter referred to as "pharmacies").

10.3.Organizations specified in Articles 10.2.1 and 10.2.2 of this Law may establish branches to sell medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices at wholesale prices.

10.4.Supply organizations shall implement proper practices and comply with national standards in their operations.

10.5.The state veterinary inspector from the state administrative body in charge of livestock and animal health issues shall oversee the activities of supply organizations.

10.6.Supply organizations shall notify the state administrative body in charge of livestock and animal health issues if any changes made in the documentation for produced or imported medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives at least one month before their market release, and update the registration thereupon accordingly.

10.7.Supply organizations shall promptly notify the state administrative body in charge of livestock and animal health issues of any changes in location, facilities, professional management, or quality management personnel.

10.8.Supply organizations shall submit an annual report on their produced, imported, or supplied medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives to the state administrative body in charge of livestock and animal health issues by 20th of December of each year.

10.9.The procedures for establishing, storing, transporting, calculating normal losses of the national reserves of biopreparations, and withdrawing and disposing biohazardous waste shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

10.10.In the event of a disaster or emergency situation, the state administrative body in charge of livestock and animal health issues may directly or indirectly procure vaccines that meet international quality standards for the prevention of highly contagious livestock and animal diseases from foreign manufacturers or international organizations.

10.11.No individual or legal entity other than those specified in Article 10.2 of this Law shall be permitted to engage in the manufacture, importation, or sale of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, or diagnostic devices.

Article 11.Manufacture of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices

11.A manufacture of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices (hereinafter referred to as "manufacture") shall mean a legal entity with a special permit to produce products using designated raw materials in accordance with standards and technology.

11.2.The manufacture shall meet the following general requirements:

11.2.1.to have production technology that meets national and international standards;

11.2.2.to be equipped with the designated facilities and equipment that comply with hygiene and sanitation requirements;

  11.2.3.to be met the requirements of good manufacturing practices;

  11.2.4.to be registered the medical raw materials with the registry;

11.2.5.to have a quality control system that is fully responsible for the quality and safety of the products;

  11.2.6.to obtain external quality certification for each product batch;

11.2.7.to ensure that product's packaging, labeling, and marking meet standard requirements.

11.3.The following activities shall be prohibited to the manufacture:

  11.3.1.to use the medical raw materials that are not registered with the registry;

11.3.2.to conduct production with raw materials that do not meet quality standards;

11.3.3.to manufacture products on the same premises, lines, or processes as non-pharmaceutical products;

  11.3.4.to produce counterfeit or non-standard products;

11.3.5.to give incentives to veterinary organizations based on the results of product sales or to involve them in similar activities.

11.4.Legal entities specified in Articles 10.2.1 and 10.2.2 of this Law shall supply quality-assured biopreparations to the market under the oversight of veterinary institutions according to customer orders.

Article 12.Supply distributors for medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices

12.1.A supply distributor for medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices (hereinafter referred to as "the supply distributor") shall mean a legal entity supplying them in whole to pharmacies based on the contracts.

12.2.The supply distributor shall comply with relevant standards in its operations.

12.3.The supply distributor shall meet the following general requirements:

  12.3.1.to have qualified professional personnel;

12.3.2.to maintain an internal control system fully responsible for the quality and safety of imported and supplied products;

12.3.3.to ensure that medical devices undergo inspection, calibration, and certification;

12.3.4.to provide documentation proving quality assurance for each batch of medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives when supplying them to pharmacies.

12.4.Veterinary institutions shall purchase medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, feed additives, and diagnostic devices from manufacturers or importers with special permits based on contracts.

12.5.When importing and supplying medical devices, technical and quality assurance documents shall be provided.

12.6.The supply distributor shall be fully responsible for the quality, safety, installation, training, maintenance, and adjustment of the medical devices supplied within the warranty period.

12.7.The following actions shall be prohibited for the supply distributor:

12.7.1.to import medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices without the necessary special permit;

12.7.2.to supply medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices those are failed to be registered, without quality assurance and labels, or of which validity date has expired;

12.7.3.to give incentives to veterinary organizations based on their sales of medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives, or to involve them in similar activities;

12.7.4.to import or sell the counterfeit or unregistered medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, or feed additives;

12.7.5.to violate the storage, distribution, or usage instructions, procedures, or standards;

12.7.6.to sell medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives directly to herders or citizens.

12.8.Matters related to the inspection, adjustment, and certification of veterinary equipment that are not regulated by this Law shall be governed by the Law on Metrology and other relevant legislation.

Interpretation: "Medical devices" shall mean the equipment, accompanying items, and software used for diagnosing, treating, nursing, preventing livestock and animal diseases and conditions, monitoring bodily structure and functions, as well as for replacement and rehabilitation purposes in veterinary medicine and pharmaceutical production.

Article 13.Pharmacy

13.1.A pharmacy shall mean a legal entity engaged in the retail sale of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, and feed additives.

13.2.The pharmacy shall comply with applicable standards in its operations.

13.3.A licensed veterinarian or veterinary pharmacist shall work at the veterinary pharmacy to operate.

13.4.The pharmacy shall purchase medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, and feed additives from manufacturers or supply distributors based on contracts.

13.5.The list of human medicines and medical devices to be used for livestock and animal treatment and services shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

13.6.Veterinary organizations and pharmacies shall purchase medicines and medical devices listed in Article 13.5 of this Law, from the competent human medicine and medical device suppliers with special permits based on contracts.

13.7.The following activities shall be prohibited in the operation of the pharmacy:

  13.7.1.to employ individuals other than those specified in Article 13.3 of this Law;

13.7.2.to violate procedures regarding the storage, labeling, transportation, and distribution of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, and feed additives;

13.7.3.to dispense prescription medicines without a prescription or dispensing medicines based on non-standard prescriptions.

Interpretation: "Livestock and animal/veterinary medicine prescription" shall mean a document specifying the method of preparation, dispensing, and use of medicines for livestock and animals, issued by a veterinarian to a pharmacist, pharmaceutical technician, or dispenser.

13.7.4.to provide services with counterfeit or unregistered medicines, biopreparations, disinfection preparations, antiseptic preparations, or feed additives;

13.7.5.to dispense medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, or feed additives to be used by human;

13.7.6.to sell by pricing the medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, feed additives, or diagnostic devices that were provided as aid, donations, or from budgetary funds.

Article 14.Prohibitions for herders, animal caretakers, and individuals or legal entities who own livestock or animals.

14.1.The followings shall be prohibited to herders, animal caretakers, and individuals or legal entities who own livestock or animals:

14.1.1.to purchase or use counterfeit, unregistered, non-quality-assured, or expired medicines, biopreparations, disinfection preparations, antiseptic preparations, and feed additives;

14.1.2.to store medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, or diagnostic devices in non-designated places;

14.1.3.to use biopreparations or prescription medicines on livestock and animals without the authorization of a veterinarian.

Article 15.Entering medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices across state borders

15.1.The Government shall designate the border crossing points for entering medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices.

15.2.Import and export ordinary permits shall be obtained from the state administrative body in charge of livestock and animal health issues.

15.3.The ordinary permit shall specify the name, form, dosage, quantity, manufacturer's name, entering period across the state border, and border crossing point for the medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices.

15.4.In cases of disasters or emergencies, if it is essential to import unregistered medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, or diagnostic devices, an ordinary permit shall be issued by the decision of the relevant state administrative body in charge of livestock and animal health issues based on the recommendation of the Council.

15.5.Importers of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices shall have a commercial agreement made with the manufacturer or its authorized distributor, and exporters shall have a commercial agreement made with the purchasing organization.

15.6.The medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices under the aid or donation shall meet the following requirements:

15.6.1.to have a certificate/reference from the competent authority confirming their compliance with international standards;

15.6.2.for the goods that are newly manufactured and supplied, which possess a shelf life exceeding two years at the time of delivery, at least two-thirds of the shelf life shall be unexpired, for goods with a shelf life of two years or less, at least three-quarters of the shelf life shall be unexpired;

15.6.3.the label shall include information regarding the general name, form, dosage, quantity, batch number, name of the country of origin, name of the manufacturer, as well as details about storage conditions and expiration date.

15.7.For receiving medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices under the aid or donation, both the donor and the recipient shall enter into an agreement that includes the following provisions:

  15.7.1.the party in charge of transportation, distribution, and related costs;

15.7.2.the party in charge of payment of taxes to be imposed on humanitarian and donated goods, except for those exempted under the Law on Customs Tariff and Customs Duties, and the Law on Value Added Tax;

15.7.3.the party in charge of the costs associated with quality testing and assurance, and its obligations;

15.7.4.in cases where the product has expired, does not meet quality standards, is unusable, or incomplete, the party in charge of the costs associated with returning the product across the border or disposing of it, and mutual obligations and liabilities to be undertaken by both parties.

15.8.If the medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices, to be supplied under aid or donation, meet the required standards, the state administrative body in charge of livestock and animal health issues shall issue an ordinary permit on importing.

15.9.After entering the medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices to be supplied under the aid or donations across the national border, the recipient of the aid or donation shall have them tested in an accredited competent laboratory to verify their quality.

15.10.In order to obtain exemption from customs and value-added taxes for medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices to be supplied under the aid or donations, the recipient shall submit the following documents to the state central administrative body in charge of livestock and animal health issues as soon as they receive the shipment information and documents from the donor:

  15.10.1.an official letter requesting tax exemption;

  15.10.2.the agreement made between the donor and the recipient;

15.10.3.documents related to transportation and pricing, a list of packaging, and a copy of the donor organization's certification/reference.

15.11.The state central administrative body in charge of livestock and animal health issues shall submit the official letter requesting the tax exemption to the state central administrative body in charge of finance and budget issues within 5 working days upon receipt of the documents specified in Article 15.10 of this Law.

15.12.The following actions shall be prohibited in relation to the import and export of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices:

15.12.1.to enter them across the state border through a border crossing post other than those established under Article 15.1 of this Law;

15.12.2.to import the medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices with labels of "Made in Mongolia";

  15.12.3.to import by legal entities without special permits;

15.12.4.to enter the medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, or diagnostic devices that exceed or differ from the name, form, dosage, or quantity specified in the ordinary permit, across the state border;

15.12.5.to receive anesthetics, pain relievers, or tranquilizers intended for veterinary use via postal shipment;

15.12.6.it has been established that there has been a breach of the storage and transportation conditions;

15.12.7.to enter counterfeit, non-standard, non-compliant with storage and transportation requirements, or expired medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, or diagnostic devices under the aid or donations.

15.13.Relations other than those regulated by this Law regarding the entering of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices across the state border shall be governed by the Law on Customs.

Article 16.Regulation of anesthetics, pain relievers, and tranquilizers for livestock and animals

16.1.Veterinary organizations shall submit reports on the procurement, usage, expenditure, and application of anesthetics, pain relievers, and tranquilizers for livestock and animals to the state administrative body in charge of livestock and animal health issues within the timeframes specified by law, either in writing or electronically.

16.2.The annual report on the anesthetics, pain relievers, and tranquilizers for livestock and animals shall be submitted by the state administrative body in charge of livestock and animal health issues to the state central administrative body in charge of health issues and the central police organization within the timeframes specified by law, either in writing or electronically.

16.3.The progress of the procurement, usage, expenditure, and application of anesthetics, pain relievers, and tranquilizers for livestock and animals shall be overseen by the state veterinary inspectors.

16.4.Any illegal use or expenditure of anesthetics, pain relievers, and tranquilizers for livestock and animals shall be resulted to take actions in accordance with the relevant laws.

16.5.The procedures for recording the income, expenditure, and disposal of anesthetics, pain relievers, and tranquilizers for livestock and animals used in veterinary organizations, as well as for reporting their expenditures shall be approved by the member of the Government in charge of livestock and animal health issues.

Article 17.Granting permits for medicines, medical device, and feed additives

17.1.A special permits specified in sub-paragraph 12.12 of  Article 8.1 of the Law on Permits, and an ordinary permits specified in sub-paragraph 11.4 of Article 8.2 of the same law shall be issued by the state administrative body in charge of livestock and animal health issues respectively.

17.2.An applicant for a manufacturing permit shall submit the following documents along with their application to the state administrative body in charge of livestock and animal health issues, in addition to those required by the Law on Permits:

17.2.1.a conclusion and supporting documents from a state veterinary inspector confirming the compliance with the standards and technical regulations of good manufacturing practices concerning factory buildings, facilities, their organization, and human resources;

17.2.2.documentation proving that the equipment used in production meets the essential performance and safety requirements.

17.3.An applicant for an import permit shall submit the following documents along with their application to the state administrative body in charge of livestock and animal health issues, in addition to those required by the Law on Permits:

  17.3.1.a copy of the legal entity's state registration certificate.

17.3.2.a trade agreement made with the foreign supplier organization, a power of attorney, or other documentation proving the official representation.

17.3.3.certification proving that the manufacturer or supplier meets international quality and standards requirements.

17.4.An applicant for an ordinary permit shall submit the following documents along with their application to the state administrative body in charge of livestock and animal health issues, in addition to those required by the Law on Permits:

  17.4.1.a copy of the legal entity's state registration certificate;

  17.4.2.a trade agreement made with the manufacturer or an authorized distributor;

17.4.3.certification proving that the product meets international quality and standards requirements;

17.4.4.documentation proving that at least three-fourths of the product's shelf life is unexpired;

17.4.5.information on the product's name, form, dosage, quantity, container, packaging, manufacturer's name, entering period across the state border, and the border crossing points;

17.4.6.original customs registration documents for the shipment, detailed records of container and packaging, a copy of the invoice, and certification provided by the manufacturer.

17.5.An ordinary permit shall be valid for 30 days from the date of issuance.

17.6.The state administrative body in charge of livestock and animal health issues shall decide on the issuance of permits in a timely manner, adhering to the procedures outlined in Article 5.2 of the Law on Permits.

17.7.Matters related to special and ordinary permits other than those regulated by this Law shall be governed by the Law on Permits.

17.8.The Governors at all levels shall implement the following functions regarding the supply of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations and diagnostic devices within their jurisdiction:

17.8.1.to maintain the stockpile of medicines and medical devices necessary for combating livestock and animal diseases;

17.8.2.to collaborate with professional organizations to organize public awareness, educational and promotional activities on the proper use of medicines, biopreparation, and feed additives.

Interpretation: "Proper use of medicines" shall mean administering livestock and animal medicines according to the diagnosis of the disease, in the appropriate dosage, for the intended purpose, and at the specified frequency.

CHAPTER FOUR

PROPER USE OF LIVESTOCK AND ANIMAL MEDICINES AND FEED ADDITIVES

Article 18.Prevention of microbial resistance

18.1.When implementing measures to combat and prevent microbial resistance, the principles of limitation, substitution, prohibition, and removal from registration shall be followed.

18.2.Activities related to the prevention of microbial resistance and the detection and monitoring of resistant microbes shall be based on risk assessments.

Interpretation: "Microbial resistance" shall mean the capacity of microorganisms to continue to proliferate or to exist stably when the dosage of antimicrobial agents is increased in comparison to sensitive microorganisms of the same species.

18.3.Microbial resistance testing based on a tiered improvement approach, in accordance with international standards, shall be carried out by an accredited laboratory.

18.4.A national plan for monitoring, preventing, and combating microbial resistance shall be jointly approved by the Members of the Government in charge of health issues and the livestock and animal health issues.

18.5.An annual plan for monitoring, preventing, and combating microbial resistance shall be approved and implemented by the Head of the state administrative body in charge of livestock and animal health issues based on the national plan.

18.6.The state administrative body in charge of livestock and animal health issues shall regularly report the results of microbial resistance monitoring studies, detection status, and implemented measures to the relevant international organizations.

Article 19.Prevention of medicine residues in livestock and animal

19.1.The state administrative body in charge of livestock and animal health issues shall implement corrective measures based on the laboratory analysis results regarding the threshold levels of medicine residues in livestock and animals and the names and quantitative measurements of medicines that exceed permissible limits, in accordance with international guidelines.

19.2.Recognized international methods shall be employed for the detection, identification, and confirmation of medicine residues in livestock and animal-derived food products.

19.3.The plan for detecting medicine residues, determining their levels, assessing risks, and implementing monitoring measures shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

Article 20.Regulation of proper use of veterinary medicines and feed additives

20.1.The organization specified in Article 28.1 of the Law on Livestock and Animal Health shall implement drug warnings based on principles of correct diagnosis of the disease, proper drug selection, accurate dosing, correct application methods, and appropriate timing.

Interpretation: "Drug warnings" shall mean the activities related to detecting, assessing, and preventing adverse drug effects.

20.2.Herders, animal caretakers, and owner of livestock or animals shall seek advice and instructions from a veterinarian when using non-prescription medications.

20.3.Medications to be used for the prevention and treatment of diseases in livestock and animals shall be administered according to instructions.

20.4.The procedures for issuing the prescription medication shall be approved by the Head of the state administrative body in charge of livestock and animal health issues.

20.5.Information on adverse effects of medications used on livestock and animals, microbial resistance as well as information on medicine originating residues in livestock and animals, shall be recorded by veterinary departments.

20.6.Supply distributor shall submit the reports on income and expenditure of microbial resistance and medicine originating residues in livestock and animals to the state administrative body in charge of livestock and animal health issues per semi-annually.

20.7.During the use of medicines and feed additives, veterinarians shall explain drug warnings including drug selection, safe use, side effects, and instructions for use to herders, animal caretakers, and owner of livestock or animals.

20.8.Training and awareness programs to promote proper medicine use shall be organized by veterinary organizations within their respective jurisdiction.

20.9.Veterinarians shall record and document details such as the name, date, dosage, and quantity of medicines used in livestock and animal treatment.

20.10.It shall be prohibited to herders, animal caretakers, and owners of livestock or animals from purchasing or using unregistered medicines.

20.11.Surveillance studies to determine mineral deficiencies in livestock and animals shall be conducted every five years by educational and academic institutions, commissioned by the organization specified in Article 20.12 of this Law.

20.12.Based on the surveillance studies specified in Article 20.11 of this Law, the state central administrative body in charge of livestock and animal health issues shall issue recommendations for addressing and supplementing mineral deficiencies.

20.13.Herders, animal caretakers, and owners of livestock or animals shall use medicines and feed additives containing the necessary minerals in accordance with the recommendations provided under Article 20.12 of this Law.

CHAPTER FIVE

STATE CONTROL AND INSPECTION

Article 21.Inspection of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices

21.1.The inspection of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices shall be carried out by state veterinary inspectors and state customs inspectors at the aimag, soum, the Capital city, and district levels.

21.2.The state inspectors mentioned in Article 21.1 of this Law shall oversee compliance with legislation and administrative normative acts related to medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices.

21.3.The state veterinary inspectors shall perform the following duties, in addition to the general powers specified in Article 10.9 of the Law on State Inspection:

21.3.1.to review and make a conclusion on the requests and suggestions issued by individuals and legal entities regarding the production, importation, and sale of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices;

21.3.2.to submit the grounds and conclusion on the revocation of special permits on importing for medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices, as well as the suspension or cancellation of professional certification/accreditation for veterinarians and pharmacists, to the relevant competent authorities and officials;

21.3.3.to submit their proposal on the withdrawal from the market of unregistered, untested, uncertified/unaccredited, or internationally banned medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives to the relevant competent authorities;

21.3.4.to suspend the activities of the legal entity that has committed violations in whole or in part until the violations are rectified, and if repeated, to submit a proposal to the relevant authority for the revocation of the special permit to engage in operation;

21.3.5.if prescription medications are misused, to restrict the rights of the respective households and intensive farms in that area to supply livestock, animals, and food raw materials and products derived from them to the public for a period of three months;

21.3.6.to take samples of medicines, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, and feed additives, and to draw conclusions to withdraw or destroy them in cases where they do not meet quality standards;

21.3.7.to inspect and evaluate whether supplying organizations meet standard requirements and make conclusions accordingly.

21.4.The inspection checklist for the operations of suppliers of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices, along with the risk assessment criteria, shall be approved by the Member of the Government in charge of livestock and animal health issues.

CHAPTER SIX

ADVERTISING OF MEDICINES, MEDICAL DEVICES, BIOPREPARATIONS, DISINFECTION PREPARATIONS, ANTISEPTIC PREPARATIONS, MEDICAL RAW MATERIALS, FEED ADDITIVES, AND DIAGNOSTIC DEVICES

Article 22.Information of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices

22.1.Information regarding medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices shall be aimed to be accurate, appropriate, to be used effectively, and to protect the consumer rights.

22.2.When using statistical data, pharmacological indicators, clinical research findings, and evidence in advertising, the sources thereupon shall be clearly indicated.

22.3.Governors of all levels shall organize professional training and advertising related to pharmacy for veterinarians, pharmacists, herders, animal caregivers, and livestock and animal owners either independently or in collaboration with relevant organizations.

22.4.In addition to the prohibitions outlined in Article 13.4 of the Law on Advertising, the following shall be prohibited in the advertising of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices:

22.4.1.to provide information that suggests a denial of the need for veterinary advice, treatment, or services;

22.4.2.to mislead consumers by suggesting that medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices are rare, essential, unique, extremely effective, superior to other medicines, safer, without side effects, new, or patented;

22.4.3.to promote the provision of incentives or price discounts for the purchase of medicines, medical devices, biopreparations, disinfection preparations, antiseptic preparations, medical raw materials, feed additives, and diagnostic devices to the public.

CHAPTER SEVEN

MISCELLANEOUS

Article 23.Liability to be imposed on the violators

23.1.If the actions of a public official in violation of this Law do not constitute a nature of crime or violation, he/she shall be held accountable according to the Law on Civil Service.

23.2.Individuals or legal entities that violate this Law shall be held accountable under the Criminal Code or the Law on Violations.

Article 24.Entry into force date

24.1.This Law shall enter into force on October 1, 2024.

THE CHAIRMAN OF THE STATE GREAT KHURAL OF MONGOLIA ZANDANSHATAR.G