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

E1 : Product Owner
Product owner

Product owner is referring to person, company or entity who is the legal/registered owner of the product formulation and/or process with whom the marketing authorization holder has a contract.

E1.1 Role of Product Owner

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) - Key-in the name and address of the product owner by clicking on the ‘search’ button. If the product owner is not in the database, applicant need to click ‘Not Listed’ in order to enlist the new product owner

E1.2 Letter of Authorization from Product Owner

  • All applications for registration shall be accompanied with Letter of Authorization from product owner.
      • A letter from the manufacturer or product owner authorizing the local agent to be the registration holder and to be responsible for all matters pertaining to the registration of the product

(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)


National Pharmaceutical Regulatory Agency (NPRA)

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

  • Phone: +603-7883 5400




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.

Mobile Web :

Site Last Modified

  • Last Modified: Sabtu 20 Julai 2024, 01:25:04.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Menu Utama