In accordance with the law of Vietnam, what is the definition of "A drug manufacturing line fulfilling EU-GMP requirements"?

What is the definition of "A drug manufacturing line fulfilling EU-GMP requirements"?

Pursuant to Clause 7, Article 3 of the Circular 15/2019/TT-BYT stipulating the definition of "A drug manufacturing line fulfilling EU-GMP requirements" as follows:

A drug manufacturing line fulfilling EU-GMP requirements refers to a drug manufacturing line granted EU-GMP certificate by a competent authority of a country that is a member state of EMA (European Medicines Agency).

What is the definition of "A drug manufacturing line fulfilling the requirements equivalent to EU-GMP"?

Pursuant to Clause 8, Article 3 of the Circular 15/2019/TT-BYT stipulating the definition of "A drug manufacturing line fulfilling the requirements equivalent to EU-GMP" as follows:

A drug manufacturing line fulfilling the requirements equivalent to EU-GMP refers to a drug manufacturing line granted GMP certificate by a competent authority of a country that is considered SRA.

What is the definition of "A drug manufacturing line satisfying PIC/s-GMP requirements"?

Pursuant to Clause 9, Article 3 of the Circular 15/2019/TT-BYT stipulating the definition of "A drug manufacturing line satisfying PIC/s-GMP requirements" as follows:

A drug manufacturing line satisfying PIC/s-GMP requirements refers to a drug manufacturing line granted PIC/s-GMP certificate by a competent authority of a country that is a participant in PIC/s.

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