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Corporate Service - China

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Q&A Regarding Drug Production License (3)

Answer
Q:
How to apply for changes of the permitted items for Drug Production License?
A:
If a drug producing enterprise changes the permitted items for Drug Production License, it shall apply for the change of the Drug Production License to the original issuing authority 30 days before the change the original permitted items. The permitted items shall not be changed without approval.

Q:
How long does it take for changing the permitted items for Drug Production License?
A:
The original license issuing authority shall decide whether to approve the change within 15 working days from the date of receiving the application for change of the enterprise’s permitted items.

Q:
What else needs to be done after the change of the permitting items for Drug Production License?
A:
A drug producing enterprise shall promptly apply to the administrative department for industry and commerce for the change of enterprise registration after the change the permitted items for Drug Production License has been done according to law.

Q:
How to apply for changes of the registered items for Drug Production License?
A: If a drug producing enterprise changes the registered items for Drug Production License, it shall apply to the original issuing authority for the registration of the change of the Drug Production License within 30 days after the change is approved by the administrative department for industry and commerce.

Q:
How long does it take for changing the registered items for Drug Production License?
A: The original license issuing authority shall handle the formalities for the change of the registered items within 15 working days from the date of receiving the enterprise change application.

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