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Q&A Regarding Drug Production License (1)

Answer
Q:
What is Drug Production License?
A:
Drug Production License is a legal certificate that an enterprise engaged in drug production activities should obtain according to law. Enterprises without Drug Production License shall not produce drugs.

Q:
Is there duplicate in the Drug Production License?
A:
The Drug Production License is divided into original and duplicate. The original and duplicate have the same legal effect.

Q:
How long is the validity period of Drug Production License?
A:
The validity period of the Drug Production License is 5 years.

Q:
Which enterprises need to apply for Drug Production License?
A: An enterprise engaged in drug production shall obtain a Drug Production License with the approval of the drug supervisory and administrative department of the people’s government of the province, autonomous region or municipality directly under the Central Government where it is located.

Q:
How long does it take to apply for a Drug Production License?
A: To establish a pharmaceutical production enterprise, the applicant shall apply to the drug supervisory and administrative department in the place where the enterprise is located. The drug supervisory and administrative department shall decide within 30 working days from the date of receipt of the application.

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