On November 21, 2024, the National Assembly of Vietnam adopted a law amending and supplementing the 2016 Law on Pharmacy (“Amended Law on Pharmacy”). The Amended Law on Pharmacy simplifies some procedures for the pharmaceutical field, and will take effect on July 1, 2025, except for regulations on drug registration and rights and responsibilities of certain types of pharmaceutical business.
Some outstanding points in the Amended Law on Pharmacy are presented below.
E-commerce Distribution
The Amended Law on Pharmacy allows trading in pharmaceutical products by the e-commerce channel, including e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions. Accordingly, e-commerce retail of non-prescription drugs is permitted if the drugs are neither specially controlled drugs nor drugs included in the list of drugs restricted for retail sale, and e-commerce wholesale of drugs and drug materials is permitted, as long as they are not specially controlled drugs.
New Rights for Import FIEs
The amendment provides some additional rights to foreign-invested enterprises (“FIEs”) that import drugs, including the rights to:
- Repurchase drugs and drug materials manufactured through the technology transfer of the FIE itself in Vietnam, and sell such products to wholesalers;
- Import drug materials to supply to drug manufacturers in Vietnam that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract;
- Deliver and transport drugs and drug materials the FIE has imported, outsourced for processing, or transferred technology for in Vietnam, from the FIE’s warehouse to its wholesalers;
- Deliver and transport drugs used in aid, sponsorship, humanitarian, and disease prevention and control programs to medical facilities receiving funding; and
- Transport drug materials imported by the FIE from its warehouse to drug manufacturers that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract, and transport drugs imported by the FIE and used in clinical trials sponsored by the FIE itself to the facility that conducts the clinical trial.
Drug Registration
The amendment mentions that when drug registration uses the reference results of a registration dossier appraised by other authorities (including Stringent Regulatory Authorities and authorities recognized by the Ministry of Health (MOH) based on the WHO’s classification), the appraisal period will be 9 months, while it is 12 months for a normal dossier.
Also, the renewal dossiers for drugs and drug materials are simplified; in particular, only three documents will be required for renewal: (1) application form; (2) valid certificate of pharmaceutical product (CPP) for imported drugs; and (3) report on the safety and effectiveness of the drug during circulation.
Further, drugs that were granted a five-year marketing authorization (MA) but were not actually marketed within that period would not be subject to MA renewal.
Finally, if the MA of a drug or drug material has expired but the MOH has received a dossier for MA renewal, the MA can continue to be used until its renewal dossier is approved or until the MOH issues a written notice not to renew, or to temporarily suspend the use of the MA due to a discovery that the drug poses a risk of being unsafe for users or is suspected of having fake legal documents.
Drug Importation
The Amended Law on Pharmacy permits drugs without an MA used for clinical trials (except specially controlled drugs) to be imported into Vietnam without an import license, with the quantity and type in accordance with information published on the MOH portal, based on the clinical trial protocol approved by the MOH.
Price Management
Drug importers/manufacturers are required to announce or reannounce to the MOH the proposed wholesale prices of their prescription drugs before the first batch is put on the Vietnam market, or whenever there are any changes to the proposed wholesale prices, so that the MOH can publish the prices on its portal.
Pharmaceutical business establishments (including importers, wholesalers, manufacturers, and retailers) are also required to declare the prices of drugs included in the list of essential drugs (wholesale or retail price) to the authorities to serve the synthesis, analysis, and forecast of market prices.
Transitional Provisions
Pending new, renewal, and variation dossiers for drugs and drug materials submitted before July 1, 2025, will be processed in accordance with the provisions of the 2016 Law on Pharmacy, unless the applicants request application of the provisions of the Amended Law on Pharmacy instead.
Drug prices declared or redeclared in accordance with the 2016 Law on Pharmacy will continue to be used and considered as announced or re-announced wholesale prices according to the provisions of the Amended Law on Pharmacy.
For further information, please contact:
Kien Trung Trinh, Partner, Tilleke & Gibbins
kien.tt@tilleke.com
