Vietnam: 02 general principles of application of new medicine practice and method
On April 03, 2015, the Minister of Health of Vietnam issued Circular No. 07/2015/TT-BYT specifying requirements and procedures for granting permission to apply new medicine practices and methods.
Article table of contents
According to Circular No. 07/2015/TT-BYT of the Ministry of Health of Vietnam, the application of new medicine practice and method must comply with the following general principles of application of new medicine practice and method:
- Application of new medicine practices and methods shall follow two steps: pilot and official application.
- As for medicine practices or methods stipulated at Point a Clause 1 Article 2 hereof, the research stage shall be considered as pilot application step.
However, these principles shall not apply to the following cases:
- New medicine practice or method of human organ transplantation and body donation. Application of this new medicine practice or method shall be governed by legal regulations on human organ transplantation and body donation;
- New practice or method of gender reassignment, in-vitro fertilization and surrogacy for humanitarian purposes. Application of this new medicine practice or method shall be governed by civil, marriage and family laws;
- If new medicine practices or methods stipulated in Clause 3 Article 69 of the Law on Medical Examination or Treatment have been classified into Class II, III or unknown class by the Ministry of Health, the healthcare establishment shall implement regulations laid down in the Circular No. 43/2013/TT-BYT of the Ministry of Health dated December 11, 2013 on specifying technical or professional lines in the network of healthcare establishments.
More details can be found in Circular No. 07/2015/TT-BYT of the Ministry of Health of Vietnam, effective from June 01, 2015.
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- Circular No. 07/2015/TT-BYT
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