Mongolia

Mongolia is a state in East Asia with a population of 3.1 million of people. Mongolia was not a part of the USSR, but it had close historical, political and economic ties with the Union. The country’s economy is rapidly developing to a large extent due to mining.

Mongolian pharmaceutical market is represented by 70% imported medicinal products, domestic production make up only 30%.

The circulation of pharmaceutical products is regulated by state health agencies and the Ministry of Health on the basis of relevant laws. Pharmaceutical market consists of privately owned enterprises.

Import and sale of medicinal products are authorized after their registration. Medical devices are not subject to registration, except for medical devices for diagnostics. Special food products shall undergo the state registration following a procedure similar to the registration of medicinal products. Cosmetic products are not subject to registration.

Medicinal products

Medicinal products state registration procedure is regulated by the Law of the Republic of Mongolia “On medicinal products and medical devices” and Order of the Ministry of Health of Mongolia No. 13 as of the 15^th of January 15, 2015 “On approval of the provision on registration of medicinal products and substances”.

Registration of medicinal products is carried out according to a standard or expedited procedure. The expedited registration procedure is appropriate for medicinal products that have international recognition, and registration of which is necessary in the interest of health care field in Mongolia.

The applicant shall act as an official representative of a foreign manufacturer in Mongolia or a national distributor who has a contract with the manufacturer for the registration of medicinal products listed therein.

When deciding on the state registration of medicinal products, a large number of factors are being considered, in addition to the quality, safety and efficacy criteria of the product, including:

• availability of the registered medicinal product in the Mongolian standards for diagnosis and treatment, in the registration priority list of medicinal products (the list is reviewed annually), in the list of vital medicinal products;
• presence of less than 3 registrations of the medicinal product analogues;
• availability of the medicinal product;
• world registration status of the product;
• product status with regard to innovation and originality;
• availability of the product in the WHO special lists;
• and other factors.

Manufacture of a medicinal product shall conform to the GMP requirements. However, the legislation of Mongolia does not impose special requirements on the body that issued the certificate of compliance with the standard of good manufacturing practice.

There are several other important peculiarities of the medicinal product registration in Mongolia, such as:

• the registration dossier shall include a certificate of pharmaceutical product of the Applicant’s or the manufacturing country;
• the medicinal product shall be registered in at least 3 other countries, with the exception of traditional medicinal products*;
• imported medicinal product shall be registered in the country of origin for at least 3 years *;
• medicinal products for tuberculosis treatment shall be prequalified by WHO.

* – not required for expedited registration procedure.

Registration dossier is being prepared and submitted for registration according to national specific requirements. The format of the dossier is national, that significantly differs from the CTD format.

The application and the registration dossier shall be submitted in paper form, signed and sealed by the manufacturer where required, as well as by his representative. The dossier shall be submitted in several copies, one of which is “archival”.

Certain parts of the registration dossier shall be submitted in Mongolian.

Labeling shall be performed in Mongolian, Russian and/or English, and shall comply with requirements of the Law of Mongolia “On medicinal products and medical devices.” Instruction for use shall be performed in Mongolian.

Samples and reference standards will be required in order to carry out intra-registration quality control.

Basic stages of the registration procedure:

1. Submission of the Application for registration and supporting documents to the Department of Health.
2. Submission of the registration dossier with an additional copу for archiving.
3. Preliminary (primary) examination of the registration dossier.
4. Receipt of an invoice and payment of state fees for registration and laboratory analysis.
5. Performing of laboratory quality tests.
6. Specialized examination and drawing up conclusions.
7. Deciding on registration at the meeting of the Expert Council on medicinal products, biological products and diagnostic kits.
8. Transfer of the decision on registration to the Applicant.
9. Execution and issuance of the registration certificate.
10. Adding the medicinal product to Licemed’s database.

The registration certificate is to be issued along with the approved text of the instruction for use (leaflet).

The registration certificate is valid during 5 years.

For preparations registered under the expedited procedure – 3 years.

Expedited registration procedure of a medicinal product is carried out in the interests of healthcare of Mongolia and is of two types:

Type “A”: a medicinal product is approved by the FDA, EMA, in EFTA countries and Japan,

Type “B”: the manufacturer of the medicinal product is situated in the member state of PIC/S.

Duration of the registration procedure by type A is 30 days, type “B” – 60 days.

Introduction of variation (registration of changes) shall be carried out on the basis of the official request of the manufacturer, submitted Application, substantiation of the variation being introduced and registration materials, color printed copies of labeling of primary and secondary packaging, and samples, if necessary. Depending on the nature of the variation, the examination procedure is carried out and approved at a meeting of the Expert Council on Medicinal products, Biological Products and Diagnostic Kits.

Renewal (prolongation of the registration) is carried out on the basis of the submitted Application and the following package of documents:

• an official letter of inquiry from the Applicant;
• PSUR;
• CPP (certificate of a pharmaceutical product);
• labeling of primary and secondary packaging and its graphical representation;
• instruction for use and/or leaflet for patient, in Mongolian;
• a copy of the registration certificate.

Submission of the application for renewal shall be performed until the expiration date of the Registration certificate.

Pharmacovigilance

The pharmacovigilance system in Mongolia was approved by Order of the Minister of Health No. 415 as of 07.11.2013 “On approval of registration of data on the side effects of medicinal products and safety information and rules.”

The competent authority of the pharmacovigilance system in Mongolia is the Department (division) of Medicinal products and medical devices of the Ministry of Health.

Applicants (manufacturers) are not required to appoint an authorized person responsible for pharmacovigilance in the territory of Mongolia. However, distributors and manufacturers are required to submit a general drug safety report (PSUR) to the Department of Medicinal products and medical devices of the Ministry of Health within the following terms:

• every six months during the first 3 years after registration,
• every year for the next 2 years,
• upon each renewal thereafter.

Medical devices

Medical devices and medical equipment are not subject to registration. An import license shall be obtained to carry out the import.

Medical devices for diagnostics (diagnostic kits) are subject to registration according to Order of the Ministry of Health of Mongolia No. 13 as of the 15^th of January, 2015 “On approval of the provision on registration of medicinal products and substances”.

The dossier shall be prepared and submitted for registration according to national specific requirements. The format of the dossier is national.

Registration procedure of medicinal products for diagnostics is similar to the registration procedure of medicinal products.

Special food products

The state registration procedure of special food products is regulated by the Law of the Republic of Mongolia “On medicinal products and medical devices” and Order No. 13 of the Ministry of Health of Mongolia as of the 15^th of January, 2015 “On approval of the regulation related to the registration of biologically active products”. Legislation of Mongolia determines that a biologically active product (BAP) is a product that facilitates the delivery of the necessary substances and/or calories to the human body, but is not intended for treatment. These products include classical dietary supplements (biological active supplements), as well as sport and medical nutrition.

The Application and a package of documents are to be submitted to carry out the registration procedure, as well as samples of the finished product.

Basic stages of the registration procedure:

1. Submission of the Application for registration, necessary documents and samples.
2. Preliminary (primary) examination of the registration dossier.
3. Receipt of an invoice and payment of state fees.
4. Performing of laboratory quality tests.
5. Specialized examination and drawing up conclusions.
6. Deciding on registration at the meeting of the Expert Council on biological products.
7. Transfer of the decision on registration to the Applicant.
8. Execution and issuance of the registration certificate.
9. Adding of the medicinal product to Licemed’s database.

The registration certificate of the BAP is issued for a period of 5 years.

Labeling can be performed in Russian, English or Mongolian.

Instructions for use shall be performed in Mongolian.

The application for renewal shall be submitted within 2 months till the end of the validity of the registration certificate.

Cosmetic products

Cosmetic products are not subject to registration. Samples of cosmetic products are provided for laboratory analysis. Results of such analysis are the basis for obtaining a permission to import.

Company “Cratia” offers carrying out of state registration of medicinal products, developing and maintaining of the pharmacovigilance system, registration of special food products in Mongolia.