Concept of Medicinal Herbs (According to Article 5, Clause 2 of Pharmaceutical Law No. 105/2016/QH13)
Medicinal herbs are raw materials for pharmaceuticals derived naturally from plants, animals, minerals, meeting the standards for pharmaceutical production.
Conditions for Importing Medicinal Herbs
Importing facilities for medicinal herbs must meet the following conditions:
- a) Have been issued a Certificate of Meeting Business Conditions for pharmaceutical wholesale of medicinal herbs;
- b) Comply with the principles, Good Storage Practice standards for medicinal herbs;
- c) Facilities not qualified for direct import of medicinal herbs must sign a contract for entrusted importing with a qualified importing facility, and the name of the entrusted importing facility must be indicated on the import order.
Enterprises with a Certificate of Business Eligibility for pharmaceutical production scope from medicinal herbs and a Good Manufacturing Practice (GMP) certificate can import medicinal herbs to meet their own production needs and sell to other pharmaceutical production facilities, medical examination and treatment facilities as regulated by the law.
Application for Import Permit for Medicinal Herbs (According to Article 25, Circular 03/2016/TT-BYT: Regulations on Medicinal Herbs Business Activities)
- Import order (For cases of entrusted import, the importing facility’s name must be specified on the import order).
- Quality Specification and testing method for medicinal herbs, either provided by the manufacturer or a certified copy of the quality standard from the pharmacopeia.
- For medicinal herbs containing addictive, psychotropic active ingredients, or drug precursors, a Stock Report must be included following the template specified in Appendix 05 issued with this Circular.
Procedures for Obtaining a Medicinal Herbs Import License (According to Article 25, Circular 03/2016/TT-BYT: Regulations on Medicinal Herbs Business Activities)
- The importing unit submits a complete profile to the Traditional Medicine and Pharmacy Management Department – Ministry of Health.
- Within 7 working days from the date of receiving a complete and valid dossier, the Traditional Medicine and Pharmacy Management Department – Ministry of Health reviews and issues the medicinal herbs import license according to the required form in Appendix 06 issued with this Circular. In case of non-issuance, the department provides a written response to the enterprise, stating the reasons.
- If the application for a medicinal herbs import license is found to be invalid, within 10 working days from the date of receiving the dossier, the receiving agency must notify the facility in writing to supplement and complete the dossier.
- The medicinal herbs import license is valid for a maximum of 1 year from the date of issuance.
Authority for Issuing Medicinal Herbs Import License
The Director of the Traditional Medicine and Pharmacy Management Department – Ministry of Health is responsible for issuing the Medicinal Herbs Import License.
Notes on Medicinal Herbs Import (Dispatch No.189/YDCT-QLD: Quality Control of Imported Medicinal Herbs)
Inspection of the packaging, labeling of medicinal herbs
During customs clearance must comply with Circular No. 04/2Q08/TT-BYT dated May 12, 2008, issued by the Minister of Health, providing guidelines for drug labeling. Labels must be in Vietnamese and include information such as: Medicinal herb name; Quality standard; Net weight; Lot number, production date; Expiry date; Storage conditions; Name, address of the manufacturing facility, origin of the medicinal herb; Name, address of the importing facility.
Imported medicinal herbs must prove their origin
Imported medicinal herbs must prove their origin in accordance with regulations: Certificate of Origin issued by the competent state authority (C/O).
Medicinal herbs must ensure quality as required:
- Have a certificate of product quality that complies with the standards of the manufacturing country or international standards (C/Q) (accompanied by a translation into Vietnamese) for each batch of medicinal herbs.
- Possess a test report that corresponds to the certificate of origin of the goods (accompanied by a translation into Vietnamese) for each batch of medicinal herbs, issued by the competent state authority of the exporting country.
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