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CHANGE OF SITE (COS)

1. What is the procedure & documents for COS application Type 1-5?

Veterinary:

  • The COS application can be done online via the Quest 3+ system.
  • The documents required can be referred to Appendix 7, REGOVP.
2. How much is the processing fees for COS Type 1-5?
3. What is the timeline for COS?
4. Can we change from one contract manufacturer to another contract manufacturer?
5. Can other variation changes be included with COS application?
6. How do PRH know whether their products are approved/ rejected?

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Jumaat 04 Oktober 2024, 17:31:56.

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