On September 5, 2022, Circular 08/2022/TT-BYT was issued by the Ministry of Health regulating registration for circulation of drugs and medicinal ingredients. Thus, with this circular, a series of administrative procedures in the field of registration of drugs and medicinal ingredients have been innovated and simplified compared to the old regulations (Circular 32/2018/TT-BYT).
Deputy Minister of Health Do Xuan Tuyen signed and issued Circular 08/2022/TT-BYT on regulations for registration of circulation of drugs and medicinal ingredients and this circular replaces Circular 32/2018/TT-BYT issued on November 12, 2018.
In Circular 08/2018/TT-BYT, administrative procedures in the field of registration for circulation of drugs, medicinal ingredients, dossiers for extension of circulation registration certificates, dossiers for changing circulation registration certificates, … has been simplified compared to the old regulations with 10 specific contents as follows:
- Simplify procedures for registration of circulation of drugs and medicinal ingredients
- The registration company is only allowed to amend and supplement no more than 3 times for documents related to the circulation registration certificate of drugs and medicinal ingredients
- Simplified requirements in dossiers requesting extension of registration numbers for circulation of drugs and medicinal ingredients
