Currently, in order to meet the needs of health protection and healing, more and more businesses are choosing to import herbal ingredients from abroad to Vietnam. This is also a conditional business, which needs to be licensed to import medicinal herbs to be allowed to operate. To clarify this procedure, Hong Bang Law Firm would like to send to clients the following advice:

Legal basis

• Law on Pharmacy No. 105/2016/QH13 dated April 6, 2016 of the National Assembly;
• Decree No. 54/2017/ND-CP dated May 8, 2006 guidelines for implementation of the law on pharmacy;
• Circular No. 03/2016/TT-BYT herbal ingredient trading.

General conditions for establishments applying for pharmaceutical import licenses

Vietnamese establishments importing herbal ingredients shall meet the following conditions:

• Has been granted a certificate of eligibility for drug trading with the scope of wholesale herbal ingredients.
• Follow the principles of “Good practice of drug preservation” for herbal ingredients as prescribed in this Circular examined by the Ministry of Health.
• Herbal ingredients business establishments that are not yet eligible for direct import must sign import escrow contracts with establishments eligible for import as prescribed and the name of the import escrow establishment must be shown on the import order.

Other conditions

In addition to the above conditions, the herbal ingredients import establishments when registering customs declarations must also present the original and submit to the customs office a stamped copy of the enterprise for the following papers for customs clearance procedures:

• The license for importing pharmaceuticals shall be issued by the Department of Management of Traditional Medicine and Pharmacy under the Ministry of Health in accordance with the provisions of this Circular.
• Certificate of origin of goods (C/O) of pharmaceuticals issued by competent organizations of the exporting country. In case the international treaty to which Vietnam is a member provides for the submission of certificates of origin of imported goods as electronic documents, the customs offices shall accept these documents.
• From July 1, 2016, imported pharmaceuticals in the List must have a test slip of each batch of medicinal herbs (accompanied by a translation into English or Vietnamese) of the production facility if the facility meets the standard of “Good practice of drug production” (GMP), for production establishments that do not meet GMP standards, there must be a test slip of the competent agency or organization of the exporting country. Every year, the Ministry of Health shall publish a list of pharmaceuticals that must have a test slip of a competent agency or organization of the exporting country.

Procedure

Dossier

• Import order (According to form). In case of escrowed import, the name of the escrowed import base must be shown on the name of the entrusted import facility.
• Quality standard and copy of pharmaceutical testing method, manufacturer or photocopy of quality standard thesis of pharmacopeia.
• For pharmaceuticals with addictive active ingredients, psychotropic, drug precursors must be enclosed with inventory reports (According to samples)

Competent agencies

Director of the Department of Management of Traditional Medicine and Pharmacy of the Ministry of Health issued a license to import medicinal herbs.

Implementation time

Within 07 working days after receiving a complete and valid dossier

Services of Hong Bang Law Firm

• Advise clients to prepare dossiers;
• Support clients to notarized and certify documents of foreign countries (if any);
• Draft, prepare and check the validity of the dossier;
• Represent clients to carry out procedures with competent authority;
• Hand over the results to the clients.

If you need more detailed advice and answers as well as how to access this service, please contact directly our Lawyer Nhat Nam via hotline: 0912.35.65.75, 0912.35.53.53 or call the toll free legal consultation hotline 1900.6575 or send a service request via email: lienheluathongbang@gmail.com

Wishing you and your family good health, peace and success!

Best regards!