Mongolia Drug Product Registration

Registering Drugs and Biopreparations in the Registry

A foreign manufacturer wishing to register a drug shall submit specific reference substances and reagents necessary for the respective pharmacological research and the following documents directly or through an official representative to the Pharmaceutical Board:

• A petition to register the drug (one copy in Mongolian, English, or Russian).
• Documents demonstrating compliance with the WHO GMP or Certificate Scheme.
• Materials of the results of pharmacological and toxicological testing.
• Published materials about the clinical experiments.
• The results of clinical trials.
• No fewer than 3 samples of the respective drug to be registered.
• A proposed price.

When registering import drugs, the process shall be based only on the manufacturer’s text and materials, and materials that have been signed but not stamped or that were submitted by fax shall be deemed invalid.

Registering Items of traditional or Herbal Medicines

1. “Traditional medicine” refers to medicinal items in the forms of simple or compound concoctions, powders, pills, pastes, creams, etc., prepared by methods of compounding traditional medicines or manufacturing methods based on theory and technology.
2. “Herbal medicine” refers to medicinal products with an origin in one or several plants, containing fully refined or unrefined compounds (substances), and having medicinal action effective for human bodily health.

• Compounds of traditional medicines shall be registered with the code “TM” (Traditional Medicine”) and compounds of herbal medicines with “H” (Herbal), respectively.

1. When registering traditional or herbal medicines, the following documents and conditions are required from the manufacturer:
   • The permit to manufacture traditional or herbal medicines (license).
   • The name, compound, pharmacological action, and dosage of the traditional or herbal medicine.
   • The approved standard (MNS) and technological instructions for the respective product.
   • Quality standards for raw materials of plant, animal, or mineral origin.
   • Instructions for the technology used, especially regarding what technology was used to detoxify the medicine.
   • Bottles of medicine prepared as a spirit shall be no greater than 50 ml.

• • Instructions for use approved by the Pharmaceutical Board.

Extending or Revoking Drug Registration

1. If the party seeking registration has not officially applied for an extension of the registration one month before the period of registration of the drug expires, the respective drug shall be removed from the registry, and the registration shall be deemed void.
2. In the event the period of registration has been extended, the code for said medicine shall be reused.

• If the medicine of the respective manufacturer has been fraudulently produced or bottled, a non-standard product has been used, or side-effects have been repeatedly observed during the use of a registered drug, the matter of removing the drug from the Registry shall be decided by dealing directly with the manufacturer.

Maintaining the Registry

1. The deputy chairman of the Pharmaceutical Board shall be responsible for drug registration, and a Drug Registry professional shall perform the work of maintaining documents.
2. The maintenance of documents in connection with the Drug Registry shall be based on computer programs, and the Anatomical, Therapeutic, and Chemical classification system (ATC) of the WHO shall be used.

• The registration of import medicines shall be decided within 3 months of receipt of the application, and domestic medicines within 1 month, respectively.

1. The Pharmaceutical Board shall be presented with the application to register a drug, and if it proposes to register a given drug, it shall appoint and employ clinical and pharmacological experts on every occasion.
2. The clinical assessment for an import medicine shall be issued within 14 days of receipt of materials, the pharmacological assessment within 1 month, and the clinical and pharmacological assessments for a domestic medicine within 14 days, respectively.
3. The matter shall be decided by a session of the Pharmaceutical Board within 7 days after the issue of the expert assessment.

• In the event the decision is reached to register a medicine, the registration certificate shall be issued within 5 days and delivered by mail to a foreign registrant. The registrant shall be responsible for postal expenses.

Registration Fees

The registering party shall be responsible for payments for works and services connected with registering a medicine in the National Registry. The fees shall be spent to cover such expenses as those of performing trials, performing experiments, taking it under Registry inspection, issuing the Registration Certificate, providing information connected with registration, and providing bonuses, considering the time spent by members of the National Pharmaceutical Boards and the Human Medical Sector Council in sessions.

Fast-Track Drug Registration in Mongolia

Ministry of Health (MoH) 

Ministry of Health of Mongolia

Website

https://moh.gov.mn/home

Official Language

Mongolian

Local Authorised Representative

Yes

Classification of Medical Devices

Class 1-4

Registration Timeline 

3 to 12 months

License Validity

5 Years

Registration fees

Full registration: 500,000- 3,000,000

Renewal: 250,000- 1,500,000

The registration dossier is a crucial document prepared following Mongolia’s specific requirements for the registration of medicinal products. Unlike the Common Technical Document (CTD) format, Mongolia follows a national format with distinct peculiarities. Several key considerations must be addressed when compiling the application and registration dossier for Mongolia:

Certificate of Pharmaceutical Product (CoPP): The dossier should include a CoPP from the applicant’s or manufacturer’s country.

International Registration: Medicinal products need to be registered in at least three other countries, except for traditional medicinal products, which are exempt.

Imported Medicinal Products: For imported medicinal products, a prerequisite is that the product should be registered in the country of origin for at least three years. This requirement is waived for the expedited registration procedure.

WHO Prequalification for Tuberculosis Treatment: Medicinal products intended for tuberculosis treatment must be prequalified by the World Health Organization (WHO).

The application and registration dossier are submitted in paper form, signed, and sealed as necessary. Specific parts of the dossier should be in the Mongolian language. Samples and reference standards are necessary for intra-registration quality control, and manufacturing should adhere to Good Manufacturing Practice (GMP) standards. Unlike some other countries, Mongolian legislation does not specify additional requirements for the competent authority issuing the GMP certificate.

There are two types of fast-track registration procedures in Mongolia:

• Type “A”: Products approved by reputable regulatory authorities such as the FDA, EMA, those in EFTA countries, and Japan.
• Type “B”: Products manufactured in countries that are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The duration of registration for Type “A” is 30 days, while Type “B” takes 60 days.

The steps involved in the fast-track registration procedure include submitting the application, preliminary examination, laboratory quality tests, specialized assessment, decision-making, issuance of the Registration Certificate, and finally, adding the medicinal product to Licemed’s database. This process streamlines the registration for products with established regulatory approval or from countries with high regulatory standards, contributing to the timely availability of essential medicines in Mongolia.

Registration Certificate and Labelling

• A registration certificate is issued along with the approved text of the instruction for use (leaflet).
• Labelling must be approved in Mongolian, Russian, and/or English, adhering to the requirements of the Law of Mongolia governing medicinal products and medical devices.
• The instruction for use should be in Mongolian.

Validity Period

• The registration certificate obtained through the standard registration procedure is valid for 5 years.
• For fast-track registrations, the certificate is valid for 3 years.

Variations/Changes

• Manufacturers are required to register any variations or changes to the medicinal product during the validity of the registration certificate, prior to placing the product on the market.
• Manufacturers must submit an official request, application, rationale for the variation, and registration materials. This includes colour printed copies of labelling for 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

• Renewal or prolongation of the registration is based on a submitted application and requires the following documents:
  • An official letter of inquiry from the Applicant.
  • Periodic Safety Update Report (PSUR).
  • Certificate of a Pharmaceutical Product (CPP).
  • Labelling for primary and secondary packaging with graphical representation.
  • Instruction for use and/or leaflet for patients, in Mongolian.
  • A copy of the current registration certificate.

The application for renewal should be submitted before the expiration date of the existing registration certificate.