The procedure for state registration of medicinal products 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 dated January 15, 2015 “On approval of the provision on registration of medicinal products and substances”.
An important peculiarity of the market is that only a resident of the country can act as a Marketing Authorisation Holder: 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.
We recommend to investigate and consider a number of factors prior to start of the state registration of the medicinal product in Mongolia:
- 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.
Registration dossier is prepared in accordance with national specific requirements. The format of the dossier is national and significantly differs from the CTD format.
There are a number of important peculiarities that must be taken into account when preparing the Application and registration dossier for Mongolia, such as:
- the registration dossier shall include a certificate of pharmaceutical product (CoPP) of the Applicant’s or manufacturer’s 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.
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 “for archive”.
Certain parts of the registration dossier shall be submitted in Mongolian language.
Samples and reference standards will be required in order to carry out intra-registration quality control.
Manufacture of a medicinal product shall conform to the GMP requirements. However, the legislation of Mongolia does not impose special requirements on the competent authority that issued the certificate of compliance with the standard of good manufacturing practice.
Registration of medicinal products is performed by the standard or by the fast-track procedure.
Fast-track registration procedure
The fast-track registration procedure is applicable for medicinal products registered in countries with high regulatory standards and registration of which is necessary in the interest of healthcare in Mongolia.
There are two types of fast-track registration procedures in Mongolia:
- 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 located in the member country of PIC/S.
Duration of registration for type “A” is 30 days, for type “B” – 60 days.
Steps of the registration procedure:
- Submission of the Application for registration and supporting documents to the Department of Health;
- Submission of the registration dossier with an additional copy for archive;
- Preliminary examination of the registration dossier;
- Issue of the invoices for state fees;
- Performing of laboratory quality tests;
- Specialized assessment, answers on the deficiencies, issue of the assessment conclusions;
- Making decision for recommendation for registration of the product at the meeting of the Expert Council on medicinal products, biological products and diagnostic kits;
- Transfer of the decision on registration to the Applicant;
- Issuance of the Registration Certificate;
- Adding the medicinal product to Licemed’s database.
Registration certificate, language and labeling
The registration certificate is to be issued along with the approved text of the instruction for use (leaflet).
Labeling shall be approved in Mongolian, Russian and/or English, and must comply with the requirements of the Law of Mongolia “On medicinal products and medical devices.”
Instruction for use shall be performed in Mongolian.
The registration certificate under standard registration procedure is valid for 5 years.
The registration certificate under fast-track procedure is valid for 3 years.
Variations / changes
During the validity of the registration certificate manufacturer must register the variations before the medicinal product is placed on the market.
Introduction of variation (registration of changes) shall be carried out on the basis of the official request of the manufacturer, submitted Application, rationale for 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;
- 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.
Cratia provides professional services of state registration (renewals, variations) of medicinal products in Mongolia. We have an excellent knowledge of national legislation, necessary experience and resources.