Clients Charter

Kadar pengguna: 3 / 5

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1.     PRODUCT REGISTRATION 

 

 

Full Evaluation

 

 

·         To evaluate application for registration of:

Ø Prescription drugs in 210 working days upon receipt of complete application

Ø Non-prescription drugs in 210 working days upon receipt of complete application

Ø New drugs and biological in 245 working days upon receipt of complete application

 

 

Abridged Evaluation

 

 

        To evaluate application for registration of non-prescription medicine [for products that are listed in Table V of the Drug Registration Guidance Document (DRGD)], health supplements and traditional products containing:

Ø Single active ingredient in 116 working days upon receipt of complete application

Ø 2 or more active ingredients in 136 working days upon receipt of complete application

 

·         Issuance of cosmetic notification in 1 working day for applications fulfilling the stipulated requirements

 

·         Certificate of Free Sale for Cosmetic Products in 15 working days upon receipt of complete application

 

·         Decision on application for change of registration holder in 45 working days upon receipt of complete application

 

·         Certificate of Pharmaceutical Product (CPP)/Certificate of Free Sale (CFS) in 15 working days upon receipt of complete application

 

·         Decision on application for change of manufacturing site in 60 working days upon receipt of complete application

 

2.     LICENSING 

 

·         Issuance of manufacturer’s, wholesaler’s and importer’s license in 4 working days upon receipt of complete application

 

·         Evaluation of import license application for Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX):

Ø For products involving Phase 1 Study, biological products, Cell & Gene Therapy Products (CGTPs) and herbal products in 45 working days upon receipt of complete application

Ø For products other than stated above in 30 working days upon receipt of complete application

 

 

 Review date: 12 August 2020

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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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.

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  • Last Modified: Isnin 21 September 2020, 10:03:22.
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