The Ministry of Health in Vietnam is currently soliciting feedback on proposed amendments and additions to the Law on Pharmacy, with the deadline for input set for January 15, 2024. Details and the complete draft are accessible at this link. Organizations and individuals are invited to send inputs/comments for the draft at this link.
The motivation behind these amendments is the Ministry's response to the changing needs and challenges arising from the implementation of the 2016 Drug Law over a period of more than six years. While the 2016 law successfully addressed limitations from its 2005 predecessor, it now reveals shortcomings in adapting to current practical circumstances, particularly exacerbated by the complexities of the COVID-19 pandemic. The proposed amendments aim to simplify and adjust regulations to better align with the dynamic realities of the pharmaceutical sector, enhancing overall efficiency in state management.
Structurally, the draft law modifies 38 clauses with 36 modifications, 2 additions, and 1 repeal. The scope retains the 2016 Drug Law's regulatory boundaries, focusing on interpreting terminology, state policies, pharmaceutical professions, drug business, raw materials, registration, export, import, drug recall, information, advertising, clinical trials, quality management, and pricing. The key points of the proposals are as follows:
1. Circulation registration of drugs and ingredients:
The draft law simplified the process for registration, renewal, modification and supplementation to circulation registration (i.e. Marketing Authorization – MA) in Vietnam, especially:
Registration:
The draft law streamlines the process by not requiring the re-registration of drug ingredients for the production of drugs that already have MA in Vietnam.
Regulatory reliance for new medicines approved by reference regulatory authorities: The draft law introduces the concept of regulatory reliance, which means the acceptance of the evaluation results or decisions of other trusted regulatory authorities for drug registration purposes. It also defines the criteria and procedures for recognizing the reference regulatory authorities and the scope and level of reliance.
Recognize GMP compliance assessment done by reference authorities: The draft law allows the recognition of the good manufacturing practice (GMP) compliance assessment results or certificates issued by the reference regulatory authorities or the international organizations that Vietnam is a member of or has signed a cooperation agreement with. It also stipulates the conditions and procedures for recognizing the GMP compliance assessment results or certificates.
MA extension procedure for drugs and drug ingredients:
The MA extension dossiers for drugs and medicinal ingredients which have been granted/extended for a 5-year validity MA without any severe side effects will be approved for MA extension by the DAV/MOH without requiring dossier evaluation and advisory from the MA granting Advisory Committee.
The registrant must submit an extension dossier to the DAV in order to extend the validity of the MA at least 6 months from the expiry date of the MA.
MA variations:
MA variations that are not related to the following changes will be approved by the DAV/MOH without requiring dossier evaluation and advisory from the MA granting Advisory Committee:
Changes in indications, dosage, intended users, classification of brand-name drugs, classification of reference biological products, or drugs with bioequivalence research reports; and
Changes in active pharmaceutical ingredients/herbal ingredients or concentrations thereof, dosage form, administration route or manufacturer (except for secondary packaging facility, releasing facility, or releasing location).
2. Drug advertisements/information
The draft law abolishes the procedure of verifying the content of information, advertising drugs according to the plan of reducing and simplifying administrative procedures that have been approved by the Prime Minister in Decision No. 1661 / QD-BYT. It also amends, supplements, abolishes the regulations on the responsibility of the information and advertising drug establishments to suit the new management mechanism (more focus on post-market surveillance/inspection).
3. Management of medical oxygen
The draft law proposes a definition for the term "medical oxygen" to clearly distinguish it from general pharmaceutical products. Additionally, it suggests regulations pertaining to the management of medical oxygen.
4. Digitalization of drug information, package insert
The draft law requires the drug manufacturers, importers, and distributors to provide the drug information and package insert in both paper and electronic forms. It also requires the drug information centers to establish and update the national database of drug information and package insert, and to provide the public access to the database via the internet.
5. Drug price declaration
The draft law regulates the drug price declaration for drugs that are subject to price management by the state, drugs that are purchased by the state budget, and drugs that are reimbursed by the health insurance fund. It also specifies the responsibilities and obligations of the drug manufacturers, importers, wholesalers, and retailers in declaring and publishing the drug prices.
6. Pharmaceutical business of foreign-invested enterprises in Vietnam
The draft law allows the foreign-invested enterprises to conduct the pharmaceutical business in Vietnam, including the drug manufacturing, importing, exporting, wholesaling, and retailing, under the same conditions and procedures as the domestic enterprises. It also requires the foreign-invested enterprises to comply with the laws and regulations of Vietnam on the pharmaceutical sector.
7. Incentives for investment in technology transfer
The draft law provides incentives for investment in technology transfer in the pharmaceutical sector, such as preferential tax rates, the exemption or reduction of land rent and land use fees, support for infrastructure development, the priority for credit access, and the protection of intellectual property rights. It also encourages cooperation and partnership between domestic and foreign enterprises in technology transfer.
