Section E : Supplementary Documentation (And Particulars Of Product Owner, Manufacturer, Importer And Other Manufacturer)

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E1 : Product Owner
E1.1 Role of Product Owner

Please select one of the following for status of product owner:
  • Manufacturer or
  • Product registration holder or
  • Product registration holder & manufacturer or
  • Others (If the product owner is neither of the above status) – Please enter name and address of the product owner.

E1.2 Letter of Authorization (LoA) from Product Owner to Appointed License Holder (if related)

  • All applications for registration shall be accompanied with Letter of Authorization from product owner.
  • (Not applicable if the Product Registration Holder is Product Owner).
  • Letters of Authorization (LOA) shall be valid and current at the time of submission.
  • The LOA shall be on the product owner’s original letterhead and be dated and signed by the Managing Director, President, CEO or an equivalent person who has overall responsibility for the company or organization.
  • The LOA shall state the name of the product concerned and also the name and actual plant address of the manufacturer(s) involved in the manufacture of the product.
E2 : Contract Manufacturer and Repacker
E3 : Certificate of Pharmaceutical Product (CPP)
E4 : Certificate of Free Sales (CFS) (if applicable)
E5 : Certificate of Good Manufacturing Practice (GMP)
E6 : Manufacturer
E7 : Other Manufacturer(s) Involved
E8 : Importer
E9 : Store
E10 : Summary of Product Characteristics / Product Data Sheet (if applicable)
E11 : Company Core Data Sheet (CCDS) (if applicable)
E12 : Analysis Protocol
E13 : Validation of Analysis Protocol
E14 : Other Supporting Documents
E15 : Worldwide Registration Status
E16 : Post – Approval Commitment(s)
E17 : TSE Risk-Free Commitment

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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