Vietnam Proposes Amendments to Streamline Export and Import Regulations for Herbal Ingredients and Drug

Title of document
Draft Decree on amendments to some articles of Government’s Decree No. 54/2017/ND-CP dated 08 May 2017 providing guidelines for some articles and implementation of the law on pharmacy and Government’s Decree No. 155/2018 dated 12 November 2018 on amendments to some articles related to business conditions under state management of the Ministry of Health

Description
- Amendments to regulations on export, import, registration of herbal ingredients, excipients, capsule shells, semi-finished herbal ingredients in Clause 1 Article 91, Article 93 of Decree No. 54 and point b Clause 47 Article 5 of Decree No. 155 to simplify administrative dossiers and procedures for export, import, registration of herbal ingredients, excipients, capsule shells, semi-finished herbal ingredients, creating more favourable conditions for enterprises, including allowing to replace “the Pharmacy Business License for enterprises supplying herbal ingredients, semi-finished herbal ingredients” with “Business license or equivalent documents with the trading scope in herbal ingredients”, and allows to replace “Certificate of Good Manufacturing Practice (GMP) for herbal ingredients, semi-finished herbal ingredients” with “Manufacturing License or equivalent documents with Good Manufacturing Practice Certificate (GMP) within the scope of manufacture of herbal ingredients, semi-finished herbal ingredients”.- Amendment to Point a Clause 1 Article 97 of the Decree 54 on inspection of foreign drug manufacturers in the direction of mandating the Advisory Council to consider and evaluate the conformity of exporting countries’ GMP standards with GMP principles and standards prescribed by the Ministry of Health, if the exporting countries/territories apply GMP principles and standards that are not among the GMP principles and standards announced or promulgated by the Ministry of Health.- Amendment on review of stated drug prices and the composition of the intersectoral drug pricing Council

Notifying member: Viet Nam

Notification: G/TBT/N/VNM/253

Objective tag
Reducing trade barriers and facilitating trade (TBT); Protection of human health or safety (TBT); Harmonization (TBT)

Documents

• 23_8406_00_x.pdf

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 23/03/2023
• Final date for comments: N/A
• Proposed date of adoption: N/A