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


  • 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



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