DNVN - According to Mr. Chu Dang Trung - Head of Legal - Integration Department, Department of Drug Administration (Ministry of Health), more than 7 years of implementing decrees guiding the implementation of the Law on Pharmacy have revealed a number of shortcomings and limitations in State management as well as difficulties and obstacles for businesses.
Speaking at the "Workshop to collect opinions from businesses to complete the draft Decree guiding the law amending and supplementing a number of articles of the Pharmacy Law" on February 18, Mr. Chu Dang Trung - Head of the Legal - Integration Department, Department of Drug Administration (Ministry of Health) said that the Pharmacy Law No. 105/2016/QH13 was passed by the 13th National Assembly on April 6, 2016, effective on January 1, 2017.
On that basis, the Government issued Decree No. 54/2017/ND-CP detailing a number of articles and measures to implement the Law on Pharmacy on May 8, 2017; Decree No. 155/2018/ND-CP amending and supplementing a number of regulations related to investment and business conditions under the state management of the Ministry of Health, issued by the Government on November 12, 2018. In 2023, the Government also issued Decree No. 88/2023/ND-CP amending and supplementing a number of articles of the above two decrees.
However, after more than 7 years of implementation, the decrees guiding the implementation of the Pharmacy Law have revealed a number of shortcomings and limitations in State management as well as difficulties and obstacles for businesses and organizations in implementation.
Accordingly, the decrees do not have specific regulations on the content of professional practice at the pharmacy practice certificate granting facility. Current regulations also create difficulties with the regulations on special drug control.
Typically, drug import dossiers must be specially controlled and administrative procedures have not been simplified. Regulations on reporting on export, import, inventory, and use of toxic drugs and toxic pharmaceutical ingredients are not consistent with drug management...
“To overcome the above shortcomings, the draft Decree guiding the law amending and supplementing a number of articles of the Law on Pharmacy was developed to detail a number of articles and measures for implementing the Law on Pharmacy. These amendments will promptly remove difficulties and obstacles stipulated in the previous decree guiding the implementation of the Law on Pharmacy,” said Mr. Trung.
Mr. Dau Anh Tuan - Deputy General Secretary, Head of the Legal Department of the Vietnam Chamber of Commerce and Industry (VCCI) said that the pharmaceutical industry not only plays an important role in protecting and caring for people's health but is also an economic sector with strong development potential. Building a suitable, transparent and effective pharmaceutical legal system will create favorable conditions for enterprises to produce and trade, while ensuring drug quality and health safety for people.
In recent times, the Law on Pharmacy and its implementing documents have contributed to the development of the Vietnamese pharmaceutical industry in a professional and modern direction, improving production capacity, management and quality control of pharmaceuticals.
However, to facilitate businesses in the production, trading, import and export of pharmaceuticals; to enhance transparency and simplify administrative procedures in the pharmaceutical sector, it is necessary to develop a draft Decree guiding the law amending and supplementing a number of articles of the Pharmacy Law in accordance with the actual situation.
“The draft decree needs to be updated and supplemented with regulations suitable to reality to address shortcomings in licensing, registration, drug price management, control of specially controlled drugs, medicinal herbs, excipients, capsules, and ensure drug supply in the context of epidemics and natural disasters.
At the same time, it is necessary to strengthen international integration, access advanced pharmaceutical management standards, and harmonize with international commitments of which Vietnam is a member," Mr. Anh Tuan emphasized.
Ha Anh
Source: https://doanhnghiepvn.vn/kinh-te/chinh-sach/go-kho-cho-doanh-nghiep-duoc/20250218030230717
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