Tiếng Việt
The Law amending and supplementing a number of articles of the 2024 Pharmacy Law (No. 44/2024/QH15) passed by the National Assembly on November 21, 2024, officially replaces the 2016 Pharmacy Law, with many notable new points. Below are the main contents of the important changes in this amendment.
Priority Administrative Procedures in Issuing Circulation Registration Certificates and Import Licenses
The revised Law on Pharmacy 2024 continues to improve policies to promote the development of the Vietnamese pharmaceutical industry. The goal is to turn this industry into a spearhead industry. Clause 4, Article 1 amends Clause 3, Article 7 of the Law on Pharmacy 2016, stipulating the priority of administrative procedures in the following cases:
– New drugs, rare drugs, vaccines, original brand-name drugs, high-tech drugs, the first domestically produced generic drugs, the first domestically produced similar biological products
– Drug products that are clinically tested in Vietnam or produced from medicinal materials that meet good practice standards for growing and harvesting medicinal materials.
– Drugs serving national defense and security purposes, or overcoming the consequences of natural disasters and epidemics.
– Drugs serving national scientific and technological purposes have been accepted.
Meanwhile, the current Law indicates the creation of conditions for the submission of registrations for generic drugs in the state of expiring patents or exclusivity, the first similar biological products, or priority in the sequence for rare drugs, vaccines pre-qualified by WHO – World Health Organization.
Incentive Policy and Investment Support for Development of Pharmaceutical Industry
The amended Law on Pharmacy stipulates the implementation of preferential policies as well as investment support for investment projects according to the provisions of the investment law applicable in the pharmaceutical sector.
Specifically, the amended Pharmacy Law supplements special incentive policies for new investment projects with capital of VND3,000 billion or more and disbursement of at least VND1,000 billion within three years from the date of issuance of the investment registration certificate or approval of the investment policy. These projects may include:
– Research and develop technology for producing traditional medicines from domestic medicinal herbs, herbal medicines, new medicines, new active ingredients, original branded medicines, rare medicines, first registered domestically produced generic medicines, high-tech medicines, vaccines, biological products.
– Cultivation of medicinal herbs in economically disadvantaged to extremely disadvantaged areas.
– The purpose of the research is to preserve and develop rare and endemic medicinal herb genetic resources in the country, and at the same time create new varieties from medicinal herb genetic resources that bring high economic value.
Compared to the 2016 Pharmacy Law, this is a big step forward in specifying investment incentives and supporting the development of the domestic pharmaceutical industry.
Legal Corridor for New Business Forms
The amended law creates a legal basis for two new forms of business: pharmacy chains and e-commerce.
– Pharmacy chain: Pharmacies in the system must operate according to unified quality standards, operate under the same trade name and have two or more pharmacies that are certified to be qualified to do pharmaceutical business. The new regulation also allows for the rotation of drugs and professional persons in charge within the system.
– E-commerce: For prescription drugs (which can only be traded except in some special cases, such as medical isolation due to group A epidemics), special control drugs and drugs with retail restrictions,
These regulations are a major step forward to catch up with the development trends in modern business, which were not mentioned in the 2016 Law.
Specifying the Rights and Responsibilities of Foreign-Invested Pharmaceutical Business Establishments
The Law amends and supplements Article 53a, stipulating the rights and responsibilities of foreign-invested production establishments, including:
– The right to wholesale, deliver and transport drugs and pharmaceutical ingredients manufactured or processed by the facility in Vietnam.
– The right to receive and transport drugs used for sponsorship, aid, humanitarian purposes, and disease prevention and control programs.
As for foreign-invested drug and pharmaceutical ingredient importing establishments, they have the following rights:
– Wholesale of drugs and pharmaceutical ingredients imported by the facility to establishments that wholesale pharmaceutical ingredients and drugs.
– Buy back pharmaceutical ingredients, drugs transferred by technology transfer agencies, sell drugs and pharmaceutical ingredients
– The right to import raw materials to produce drugs within the scope stated on the Certificate of Eligibility for Pharmaceutical Business.
This regulation increases transparency and creates more favorable conditions for foreign investors when participating in the Vietnamese pharmaceutical market.
Expanding Rights for Drug Manufacturing, Exporting and Importing Establishments
Clause 19, Article 1 amends point e on the rights of drug manufacturing establishments, allowing:
– Wholesale of drugs and pharmaceutical ingredients to medical examination and treatment facilities, vaccination facilities, or research and training facilities.
– Supply of drugs to drug production investment projects in Vietnam but have not been granted a certificate of eligibility for pharmaceutical business.
– Wholesale to drug rehabilitation facilities, state testing facilities, scientific and technological organizations and pharmaceutical-related training and research facilities.
This new regulation helps expand the scope of operations of production facilities, facilitating the development of new products.
Promoting Administrative Procedure Reform
The amended law focuses on reforming the procedures for granting registration certificates for drugs and pharmaceutical ingredients. New points include:
– The Ministry of Health publicly discloses information about newly issued, renewed, or supplemented licenses on the electronic information portal.
– Make the process transparent through consultation with the Drug Registration Advisory Council.
– Publicize information on non-prescription drugs after being granted MA as well as specific cases specified in Point c, Clause 8, Article 1 of the Law on Amendments and Supplements.
This reform aims to increase transparency and shorten processing time, compared to the previous centralized licensing.
Regulations on Drug Price Management Measures According to the Price Law
Clause 43, Article 1 amends Article 107, adding price management measures such as:
– Announce expected wholesale prices for prescription drugs, except for drugs exempted from announcement as stipulated by the Government.
– Propose price adjustments in case of detecting unreasonable differences between expected prices and market prices.
– Negotiate drug prices in accordance with legal regulations on prices.
These new regulations help ensure fair and reasonable drug prices, in line with the current socio-economic context.
The revised Pharmacy Law 2024 demonstrates the State’s efforts to promote the comprehensive, modern and internationally integrated development of the pharmaceutical industry. Notable changes not only facilitate business establishments, but also protect consumer rights through price control and improving drug quality.
For advice on registration services for medical equipment, dietary supplements, cosmetics, and functional foods to ensure procedures comply with current regulations, please contact us at hotline 098.546.1894, email medgatevn@gmail.com or message via fanpage now for support.