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Procedure NameProcedures for supply, receipt and use of medicines and medical devices with assistance and donations
Description

Type

LICENSE

Responsible Organization     

Name: MINISTRY OF HEALTH

Center for Health Development

Address:  Sukhbaatar district 14210,

Olympic Street - 2

Government Building VIII,

Ulaanbaatar,
Mongolia

E-mail:  info@moh.gov.mn

Website:   https://www.mohs.mn/

Phone:  (976) 51-263695

Fax : 11-320916

Legal basis of the procedure

Procedures for receiving medical devices, 2016

Fees / charges

 N/A

Requirements for medicines and medical supplies supplied by donations:

  • Medicines and medical supplies to be provided through aid, donations, projects and programs meet the following requirements. These include:

No.

Document type

Attention

1

Have a Drug Product Certificate in the WHO Certification Scheme for International Drug Trade or a certificate from a competent authority proving that the manufacturer complies with the requirements of the GMP;

 

 

 

 

  • It is prohibited to supply new drugs that are not included in the Medical Practice through grants, donations, projects and programs.

  • The supply of narcotic and psychotropic drugs through aid, donations, projects and programs is prohibited.

  • It is prohibited to sell drugs and medical devices supplied through aid, donations, projects and programs.

  • The decision to revoke the import license shall be notified to the import license holder and the customs and border specialized inspection service, committee and department within 3 working days.

  • Violators of this regulation shall be held liable in accordance with applicable law.

  • Relations related to import and export licenses for medicines and medical devices supplied within the framework of international projects, programs, humanitarian and grant aid shall be regulated by the “Procedure for issuing import and export licenses”.

2

Medical devices must have a certificate from an authorized body certifying that they meet the requirements of international standards (ISO);

3

Medicines and medical devices to be used for diagnosis and treatment in Mongolia for humanitarian purposes must be accompanied by the relevant documents of the supplier and the health organization:

4

Be included in the list of essential national drugs used in the treatment of diseases and disorders common in Mongolia, or in the list of essential drugs of the World Health Organization;

5

If a drug is provided by a domestic drug manufacturer, drug supplier, business entity or individual with assistance and donations, the drug must be registered in the Mongolian Drug Registry:

6

Medicines and medical devices are newly manufactured, have not been used before, and at the time of delivery, goods with a shelf life of more than 3 years (4/6) have not expired, and goods with a shelf life of 3 or less (3/4) have not expired:

7

The drug manufacturer's model is not a sample, and the drug must be internationally recognized:

8

The drug label shall contain information on generic and trade names, form, dosage, quantity, serial number, country of origin, manufacturer's name, storage conditions and shelf life;

9

Labels of medicines and medical devices shall be in the language of the country of manufacture and instructions for use shall be in English, Russian or Mongolian:

10

To have a form and dose similar to the drugs used in medical care in Mongolia;

11

Packaging for transportation meets the requirements of international freight, each box contains the general name, form, dosage, quantity, quantity, serial number, storage conditions and duration of the drug, cold chain mode registration sheet, transported by special means, mode of transport not to be lost;

12

Medicines and medical devices should not be packed with other goods;

13

The packaging of the drug should be intact (not incomplete when used by the patient);

14

Not a free sample for a medical professional;

15

The cost of medicines and medical devices should not be higher than the average market price;

Request and resolution process

Step1

The donor and the recipient shall enter into an agreement to receive medical supplies with assistance and donations; See below for details of the contract.

The donor shall notify the recipient in advance of the arrival of the donated goods.

Step2

The Center for Health Development will provide a database access number and password.

Step3

Applications for import licenses must be entered into the Health Development Center's electronic database by the recipient, project coordinator or donor. 

Step4

The Center for Health Development will review the Application and the documents submitted.

Step5

The Center for Health Development shall issue an import license if the drugs and medical devices supplied through aid, donations, projects and programs meet the requirements.

General requirements for receiving aid, donated medicines and medical supplies:

1. The donor and the donor shall agree in advance with the state central administrative body in charge of health or the health organization receiving the donation on the type and quantity of drugs and medical devices to be provided for medical care.

2. Both the donor and the recipient shall enter into an agreement for the receipt of medicines and medical supplies to be provided through grants, projects and programs.

The agreement covers the following:

  • The organization receiving aid and donations shall inform the donor in advance about the requirements for aid drugs and medical devices, and clearly indicate the person responsible for the costs related to the transportation of aid, donation drugs and medical devices;
  • Indicate the responsibility for the costs associated with quality assurance;
  • Mutual responsibilities and obligations of the person responsible for the costs related to the repatriation and destruction of medicines and medical devices supplied through aid, donations, projects and programs, in case of expiration, expiration, substandard, unusable or incomplete equipment. reflect.
  • Article 2.2 shall not apply to the donation of medicines and medical devices by citizens, business entities and non-governmental organizations during natural disasters, emergencies, accidents, communicable diseases and outbreaks of international quarantine diseases .
  • The donor shall notify the recipient in advance of the time of arrival of the aid, the name of the medicine or medical device, the dose, the manufacturer and the expiration date.
  • The Center for Health Development shall issue an import license if the drugs and medical devices supplied through the aid, donations, projects and programs meet the requirements of this regulation.
  • After crossing the border, the quality control of medicines and medical devices supplied by aid, donations, projects and programs shall be certified by the State Border Inspector based on the certificate of the competent authority of the manufacturer or importer and, if necessary, the results of laboratory tests However, domestic pharmaceutical manufacturers and suppliers will be required to provide a quality assurance certificate for the supply of medicines and medical supplies.
  • Project coordinators shall submit information on the types, prices, quantity and delivery time of drugs and medical devices to be supplied through international organizations' projects and programs to the financial unit of the state central administrative body in charge of health within the third quarter of the previous year.
  • In accordance with the agreement concluded between the Government of Mongolia and a foreign government and an international organization, the State Administration of Health shall calculate the unit cost of withdrawal, storage, distribution and analysis of medicines and medical devices from the customs warehouse within the third quarter of the previous year. submitted to the unit in charge of financial affairs of the central organization and reflected in the budget.
  • The Drug Supply Organization, which has a contract with the State Central Administrative Body Responsible for Health, shall be responsible for withdrawing, storing and distributing drugs and medical devices to be supplied by projects and programs of international organizations from the customs control zone and customs bonded warehouses.
  • Distribution of medicines and medical devices to be provided by aid, donations, projects and programs shall be agreed upon by the receiving organization in consultation with the state central administrative body in charge of health matters.

 PLEASE NOTE:

The organization receiving aid and donations shall register the medicines and medical devices received as aid, donations, projects and programs in the working capital, monitor their use, calculate the expenditure and efficiency, and report back to the state central administrative body in charge of health.

 

 

 

CategoryImport

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
This License form applies to traders wishing to import/export of medicines and medical devices. License relates the Import License procedure for medicines and medical devices30-07-202008-10-2020Ministry of HealthThis is Dowload File
This form applies to the 2016 Regulations on the Supply, Receipt and Use of Medicines and Medical Devices through Donations, 2016 A/23226-08-202002-11-2020Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
License requirement for supply, receipt and use of medicines and medical devices with assistance and donations 2016 A/232Licensing RequirementMinistry of HealthAs per the Order on Procedure for receiving medicines and medical devices, this measure applies to receive medicines and medical devices with assistance and donations Preliminary permission shall not be required for the delivery of medicines and medical devices required in case of natural disasters, emergencies, accidents, and outbreaks of communicable diseases of general danger,Approval of procedure / Procedures for supply, receipt, and use of medicines and medical devices with assistance and donations, 201631-12-9999Good
Import license for drugs and medical devices supplied under foreign projects, programs, humanitarian and grant aid, 2016 A/232Licensing RequirementMinistry of HealthAs per the Order on import and export of medicines and medical devices, this measure applies to traders who want to import medicines and medical devices any other country to Mongolia.The application for a license shall clearly indicate the type, dosage, packaging, name of the manufacturer, quantity and border crossing of the drugs and medical devices to be imported in the shipmentApproval of procedure / Procedures for supply, receipt, and use of medicines and medical devices with assistance and donations, 201631-12-9999Good