Vietnam’s pharmaceutical industry is developing strongly due to the increasing demand for natural products. In addition to using domestic products, customers also want to use foreign medicinal products. Therefore, the demand for importing medicinal materials is also growing. However, not everyone knows what steps are required to import medicinal materials and what legal documents are required. The following article will provide complete information on the conditions and procedures for importing medicinal materials so readers can better understand!
Assessment of the current demand for importing medicinal herbs in Vietnam
The current demand for importing medicinal herbs in Vietnam is increasing:
Shortage of domestic supply
– Limited domestic output: Although there are abundant resources, the ability to exploit and produce them cannot meet the demand.
– Uneven quality: Some domestic medicinal herbs do not meet the standards required for high-end pharmaceutical production.
Dependence on special medicinal herbs
– Medicinal herbs not available domestically: Vietnam must import medicinal herbs that cannot be grown in the climate and soil conditions: ginseng, lingzhi, etc.
Growing consumer market
– Increasing domestic demand: With increasing awareness of health and the trend of using natural products, the demand for medicinal herbs in Vietnam is increasing sharply.
– Development of traditional medicine: Vietnam’s traditional medicine industry is growing strongly, leading to high demand for medicinal herbs, both domestic and imported, to meet the needs of treatment and health care.
The demand for importing medicinal materials in Vietnam is currently increasing
Legal regulations on procedures for importing medicinal materials
To understand the process of importing medicinal materials, we first need to know the legal regulations and the latest documents, including:
- Decree 54/2017/ND-CP was issued on May 8, 2017, detailing several articles and measures to implement the Law on Pharmacy.
- Circular 03/2016/TT-BYT was issued on January 21, 2016, and effective on March 6, 2016, regulating the business of medicinal materials.
- Circular 48/2018/TT-BYT was issued on December 28, 2018, on the list of medicinal herbs, extracts from medicinal herbs, essential oils for medicinal use, traditional medicines, and medicinal herbs for export and import with identified commodity codes according to the list of Vietnamese export and import goods.
- Circular 03/2021/TT-BYT issued on March 4, 2021, partially abolishing the provisions in Appendix 1 issued together with Circular No. 48/2018/TT-BYT dated December 28, 2018, of the Minister of Health.
- Other relevant documents.
What is a license to import medicinal materials?
To import medicinal materials into Vietnam, businesses are required to have an import license, an important document issued by a competent authority. This license allows businesses to import raw materials from abroad for use in drug production. These raw materials must be of natural origin from animals, plants, or minerals, and must comply with strict standards during the drug processing process.
Goods requiring an import license include raw medicinal materials, extracts from medicinal materials, essential oils used in medicine, traditional medicines, and medicines processed from medicinal materials. The detailed list of these items is clearly stated in Circular 48/2018/TT-BYT of the Ministry of Health.
Conditions for permission to import medicinal materials
According to Circular 03/2016/TT-BYT, to be permitted to import medicinal materials into Vietnam, enterprises must meet several important conditions. The conditions include:
06 conditions for importing medicinal materials
Certificate of eligibility for business
The enterprise must be granted a certificate of eligibility for drug business, with the scope of activities related to trading medicinal materials.
Professional manager
The person responsible for professional management of the enterprise must have a pharmacy practice certificate, as prescribed in Article 15 of Decree 79/2006/ND-CP, issued on August 9, 2006, of the Government (except for cases specified in Article 11 of Circular 03/2016/TT-BYT).
Business location
If the enterprise has many locations or different forms of drug business, only one professional manager is required, provided that this person meets all requirements.
Conditions for each type of business
Enterprises must ensure compliance with the conditions corresponding to each type of business, as stipulated in Articles 5, 6, 7, and 8 of Circular 03/2016/TT-BYT.
Import entrustment
If the enterprise is not qualified to directly import, it must entrust another qualified unit to carry out the import. The name of this entrusted unit must be clearly stated in the order.
Compliance with storage regulations
In the case of importing medicinal materials subject to inspection by the Ministry of Health, enterprises must comply with the principles of good storage practices for drugs.
These regulations ensure that the import of medicinal materials is carried out safely and effectively, contributing to maintaining the quality and safety of medicinal products on the Vietnamese market.
What documents are required for a license to import medicinal materials?
The application for a license to import medicinal materials is stipulated in Article 25 of Circular 03/2016/TT-BYT on the business of medicinal materials issued by the Minister of Health as follows:
- Import order according to the form specified in Appendix No. 04 issued with this Circular. In the case of entrusted import, the import order must show the name of the entrusted import facility.
- The quality standards and testing methods of medicinal materials, from the manufacturer or a photocopy of the quality standards of the pharmacopeia.
- For medicinal materials containing addictive active ingredients, psychotropic substances, and drug precursors, an Inventory Report must be submitted according to the form specified in Appendix No. 05 issued with this Circular.
Procedures for importing medicinal materials
To apply for a license to import medicinal materials in Vietnam, the process is guided by Article 88 of Decree 54/2017/ND-CP and Article 26 of Circular 03/2016/TT-BYT. The steps include:
Procedures for importing medicinal materials
Step 1: Prepare and submit documents
Individuals or businesses wishing to import medicinal materials need to prepare a complete set of documents, including all necessary documents. This document is then submitted directly or sent by post to the Department of Traditional Medicine and Pharmacy Management under the Ministry of Health.
Step 2: Process documents
Receiving documents: After receiving the documents, the Ministry of Health will issue the enterprise a Document Receipt, according to form 01 in Appendix I of Decree 54/2017/ND-CP.
Checking and approving: The Ministry of Health will check the completeness and validity of the documents. If the documents are valid, the Ministry will issue an import license within 7 days from the date recorded on the Receipt. If the documents need to be supplemented, the Ministry of Health will request the enterprise to amend them within 10 days. After the enterprise completes the amendment and resubmission, the Ministry will continue to review and issue the license within the next 10 days. If the additional documents still do not meet the requirements, the Ministry will notify and request amendments.
Unsatisfactory documents: If the enterprise does not implement the amendment requirements within 6 months from the date of receipt of the notice, or if the documents still do not meet the requirements after 12 months from the first submission, the documents will be considered invalid.
Step 3: Receive results
The enterprise will receive the import license at the one-stop department of the Department of Traditional Medicine and Pharmacy Management – Ministry of Health.
Note: This procedure only applies to commonly imported medicinal materials. For medicinal materials on the special control list, there will be separate regulations and procedures to follow.
Notes when importing medicinal materials
Place to submit an application
Application for import license of medicinal materials must be submitted to the Department of Traditional Medicine and Pharmacy Management – Ministry of Health. Address: No. 138A Giang Vo, Ba Dinh District, Hanoi City, Vietnam.
Application can be submitted directly to the one-stop department of the Department of Traditional Medicine and Pharmacy Management or sent by post to the above address.
Time limit for processing application
Upon receiving a complete and valid application for an import license of medicinal materials, the Department of Traditional Medicine and Pharmacy Management – Ministry of Health will issue a license to the facility within 7 days from the date of receipt of the application, based on Appendix No. 06 of Circular 03/2016/TT-BYT. If the license is not granted, the Department will send a notice explaining the reason for refusal.
Expiry date of imported medicinal materials
According to Article 90 of Decree, 54/2017/ND-CP, the requirements on the expiry date of medicinal materials when imported into Vietnam at the time of customs clearance are stipulated as follows:
- For imported pharmaceutical ingredients (except for ingredients specified in Clause 3, Article 90 of the Decree): If the remaining shelf life of the ingredient is more than 24 months, the remaining shelf life must be at least 18 months; if the remaining shelf life is 24 months or less, the remaining shelf life must be at least half of the remaining shelf life.
- For pharmaceutical ingredients specified in Articles 67, 73, 74, 75, 82, 83, 84, 85, 86 and Point b, Clause 1, Article 68 of Decree 54/2017/ND-CP: The ingredient must still be within its shelf life at the time of customs clearance.
- In case the remaining shelf life of pharmaceutical ingredients is shorter than that prescribed in Clauses 1 or 2 of Article 90 but is still necessary for production, disease prevention, or treatment, the Minister of Health may grant an import license.
SSR Logistics – A reputable and quality procedures for importing medicine unit
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Through this article, SSR Logistics hopes that customers have an overview of Procedures for Importing Medicine in import and export. To explore more diverse knowledge in the field of logistics, please visit our Logistics Knowledge section.
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