| Description |
Required Documents
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No.
|
Type of information
|
Note
|
|
1
|
Have a Certificate from the World Health Organization's International Drug Trade Certification System or a certificate from a competent authority proving that the manufacturer meets the requirements of the Good Practice Manufacturing Practice (GMP)
|
|
|
2
|
Medical devices must have a certificate from an authorized organization certifying that they meet the requirements of international standards (ISO)
|
Other requirements for veterinary drugs and medical supplies to be donated
|
No.
|
Type of information
|
Note
|
| 1 |
Be included in the list of essential drugs used for prevention and treatment of infectious, non-infectious and parasitic diseases and diseases of animals prevalent in Mongolia, or in the list of essential drugs of the World Health Organization |
|
|
2
|
Supplied drugs and medical devices shall be newly manufactured and not used before, and at the time of delivery, 2/3 of the goods with a shelf life of more than 2 years shall not have expired, and 3/4 of the goods with a shelf life of up to 2 years shall not have expired
|
|
|
3
|
Veterinary drugs and medical supplies to be donated must not be a sample of the drug manufacturer
|
| 4 |
Drug label shall contain information on general name, form, dosage, quantity, serial number, country of origin, manufacturer's name, storage conditions and shelf life |
|
| 5 |
Labels of medicines and medical devices shall be in English and Russian and instructions for use shall be written in Mongolian only |
|
| 6 |
To have a form and dosage similar to the drugs used for veterinary measures in Mongolia |
|
| 7 |
The packaging for transportation shall meet the requirements for international cargo transportation, each box shall be labeled with the general name, form, dosage, quantity, serial number, storage conditions, time and weight of the drug, and the weight of the box shall not exceed 50 kg. |
|
Process Steps
|
Step 1
|
The donor and the recipient shall enter into an agreement to receive medicines and medical devices with assistance and donations; and the agreement shall include the following:
- Requirements for aid, donated drugs and medical devices;
- The person responsible for transportation, distribution and related expenses of aid and donation goods;
- A person responsible for taxes on aid and donations other than those specified in the Customs Tariff, Customs Tax Law and the Value Added Tax Law;
- The person responsible for the costs related to quality testing and certification and his / her duties
|
|
Step 2
|
The donor shall notify the recipient in advance of the time of arrival of aid and donated goods.
|
|
Step 3
|
Recipients of assistance and donations shall submit an application for an import license with required documents to the General Authority for Veterinary Services
|
| Step 4 |
The General Authority for Veterinary Services reviews the application |
| Step 5 |
The General Authority for Veterinary Services shall issue an import license if the aid, donated drugs and medical devices meet the requirements specified in the regulations |
NOTE
- Donors and reciepient shall agree in advance with the State Central Administrative Body Responsible for Food and Agriculture on the types and quantity of medicines and medical devices to be provided for veterinary measures in Mongolia
- Goods received as humanitarian and grant aid in accordance with an agreement concluded with a foreign government or international organization shall be exempt from Customs and value-added tax in accordance with the Law on Customs Tariff, Customs Duty and Value Added Tax.
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