إجراء مقترح من فيتنام: مستلزمات المختبرات الطبية

This draft Circular amends Clause 3 of Article 14 and Clause 2 of Article 15 of Circular No. 07/2022/TT-BYT. It sets the deadline for publication of medicinal products with documentation demonstrating bioequivalence at 1 November 2026 (1 November 2028 for products containing active ingredients no. 13–26 of Appendix I to Circular No. 07/2022/TT-BYT or in enteric-coated dosage forms. Article 1. Amendments and supplements to a number of articles of Circular No. 07/2022/TT-BYT dated 5 September 2022 of the Minister of Health prescribing medicinal products subject to bioequivalence studies and requirements for bioequivalence study reports in applications for marketing authorization of medicinal products in Viet Nam 1. Clause 3 of Article 14 is amended and supplemented as follows: 3. For medicinal products that have been granted marketing authorization and contain active ingredients or are in dosage forms subject to bioequivalence testing in accordance with this Circular: a) By no later than 1 November 2026, medicinal products must be published as products with documentation demonstrating bioequivalence, except for medicinal products containing active ingredients listed from item 13 to item 26 of Appendix I issued together with this Circular, or medicinal products in enteric-coated dosage forms, for which the publication deadline is no later than 1 November 2028. If a medicinal product has not been published by the prescribed deadline, the release of batches for circulation in…