Pharmaceutical import services play a crucial role in the healthcare industry, facilitating the supply of pharmaceutical products from manufacturing countries to importing nations to meet the healthcare needs of the population. So, how are the import procedures conducted? In the following article, Medgate will share information on the procedures for importing pharmaceuticals into Vietnam.
Legal basis
- Law on Pharmaceuticals No. 105/2016/QH13 issued on April 6, 2016.
- Decree No. 54/2017/NĐ-CP issued on May 8, 2017, detailing certain provisions and measures for implementing the Law on Pharmaceuticals.
- Decree No. 155/2018/NĐ-CP issued on November 12, 2018, amending and supplementing certain regulations related to investment and business conditions within the state management scope of the Ministry of Health.
- Circular No. 03/2016/TT-BYT issued on January 21, 2016, regulating business activities related to pharmaceutical materials.
Regulations on pharmaceutical import procedures into Vietnam
– Products must be pharmaceuticals licensed for circulation in the market in one of the following countries: the manufacturing country, a member country of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), or Australia.
– Complete clinical data on safety and efficacy according to the drug registration regulations of the Ministry of Health.
– Drugs used for emergency, antidote, and transplant rejection purposes.
– Drugs used in the diagnosis, prevention, or treatment of diseases such as infectious diseases in group A, cancer, HIV/AIDS, viral hepatitis, tuberculosis, malaria, and other diseases as determined by the Minister of Health
Documentation and Procedures for Importing Pharmaceutical Products
- a) Three original copies of the import order using Forms 15, 16, or 17 in Appendix III issued with this Decree.
- b) An original or notarized copy of the Pharmaceutical Product Certificate.
- c) A notarized copy of quality standards and drug testing methods from the manufacturing facility, sealed by the importing facility.
- d) One original set of labels and usage instructions for the currently circulating drug in the country where the Pharmaceutical Product Certificate is issued, unless the label and usage instructions are attached to the Pharmaceutical Product Certificate.
- e) Two sets of proposed labels to be used in Vietnam, along with Vietnamese-language usage instructions, sealed by the importing facility.
- f) Clinical data on safety and efficacy according to the drug registration regulations of the Minister of Health. For vaccines, additional results of clinical trials in Vietnam are required as per the drug registration regulations of the Minister of Health.
- g) Report on drug business results in cases where the imported drug falls under the categories of addictive drugs, psychotropic drugs, precursor drugs, combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursor substances, drugs in the Drug List, or substances in the List of prohibited substances in certain sectors, as per Form 18 in Appendix III issued with this Decree.
- h) An original or notarized copy of the Good Manufacturing Practice (GMP) certificate for all participating manufacturing facilities in the case of drugs produced by multiple facilities.
- i) A notarized copy or a copy sealed by the facility of the Radiation Work for the importing facility in the case of importing radiopharmaceuticals. If a sealed copy is submitted, the original must be presented for verification.
Criteria and Documentation for Import License Application to Meet Urgent Needs for Defense, Security, Disease Prevention, and Disaster Recovery
Drugs are only permitted for import if they have been approved for circulation in at least one country worldwide and fall under one of the following circumstances:
- a) The Ministry of Defense recommends importing the drug to meet urgent defense needs.
- b) The Ministry of Public Security recommends importing the drug to meet urgent security needs.
- c) The Ministry of Health approves the drug for urgent needs in disease prevention, disaster recovery.
Documentation for Import License Application:
- a) Three original copies of the import order using Forms 15, 16, or 17 in Appendix III issued with this Decree.
- b) An original or notarized copy of the Pharmaceutical Product Certificate or confirmation from the authorized management agency of the exporting country regarding drug circulation in at least one country worldwide.
- c) An original or sealed copy from the authorized agency recommending or approving the request at points a, b, or c in clause 1 of this Article, including details such as active ingredients for pharmaceuticals, names of herbal medicines for herbal and traditional medicines, dosage forms, concentration or content of active ingredients for pharmaceuticals, or weight of herbal medicines for herbal and traditional medicines, packaging specifications, manufacturer, country of manufacture.
**Other cases are regulated in Section 2, Chapter IV, Decree 54/2017/ND-CP – Detailed regulations on some provisions and measures for the implementation of the Law on Pharmaceuticals
Import Procedures for Pharmaceuticals without Circulation Numbers in Vietnam
– Step 1: Apply for a pharmaceutical import license.
– Step 2: Complete the registration procedures for drug circulation.
– Step 3: Follow customs import procedures similar to those for pharmaceutical products with registered circulation numbers