Section E Natural Products

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.

E2.1 : Letter of Appointment of Contract Manufacturer from Product Owner (if related)

Applicable for product which is contract manufactured by a manufacturer who is not the product owner.

Should 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.

Should 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

E2.2 : Letter of Acceptance from Contact Mfr. (if related)

The letter of acceptance from the manufacturer shall be on the manufacturer’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 letter of acceptance 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.

E2.3 : Letter of Appointment of the Repacker from the Product Owner

Applicable when a product is repacked/packed by another company (not by the manufacturer); where the owner is appointing the manufacturer to be the repacker/packer of the product.

Reference :
Glossary Guidelines


E2.4 : Letter of Acceptance from the Repacker

Applicable when a product is repacked/packed by another company (not by the manufacturer); where the repacker/packer is accepting the appointment by product manufacturer to be the repacker/packer

Reference :
Glossary Guidelines

- E3.1 Certificate of Pharmaceutical (CPP) – attachment & Certificate No.

- E3.2 CPP Issuing Body

- E3.3 Is this product licensed to be placed on the market for use in the exporting country? & Reason.

- E3.4 Is this product in the market in the exporting country? & Reason

- E3.5 Date of issue of CPP

- E3.6 Date of expiry of CPP

• E4.1 Certificate of Free Sales (CFS) & Certificate No.

  E4.2 CFS Issuing Body

  E4.3 Date of issue of CFS

  E4.4 Date of expiry of CFS

E5.1 Certificate of Good Manufacturing Practice (GMP) & Certificate No.

E5.2 GMP Issuing Body

E5.3 Date of issue of GMP

E5.4 Date of expiry of GMP

Rereference :
Glossary Guidelines

• Please select YES or NO. If YES, please select the manufacturer from the database list. Please select the processing steps involved.
• Attach valid GMP Certificate for the manufacturer involved

• Importer Name
• Importer Address

Please select from the database list. If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

• Store Name
• Store Address

Please select from the database list. If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

Analysis Protocol

*Specification & Standard Testing Procedure (plant document)

The analytical procedures used for testing the drug product should be provided. Compendial requirements or appropriate information from the manufacturer.

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

• 9. Guideline For The Submission Of Protocol Of Analysis (POA)

Reference ICH Guidelines:

• Validation of Analytical Procedures: Text and Methodology (Q2)
• Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products -Chemical Substances (Q6A)

*Analytical Method Validation (plant document)

Analytical validation information, including experimental data, for the analytical procedures used for testing the drug product, should be provided. Compendial requirements or appropriate information from the manufacturer.

•  Assay:
  • Specificity
  • Precision (Intermediate)
  • System Suitability Test

• Related Substance:
  • Specificity
  • Precision (Intermediate)
  • System Suitability Test
  • Limit of Quantitation/Detection

• Dissolution:

• BET:
  • Routine Test / Limit Test/ Semi-quantitative test-3 Batches of Finished Products (Gel Clot), (Photometric Method)
  • Method
  • Result (raw data)
  • Routine Test / CoA for Lysate and Endotoxin (Gel Clot), (Photometric Method)
  • Method
  • Result (raw data)
  • Routine Test / List of Apparatus and Reagents (Gel Clot), (Photometric Method)
  • Method
  • Result (raw data)
  • Validation Test / Confirmation of Labelled Lysate Sensitivity (Gel Clot) - 1 batch of endotoxin
  • Method
  • Result (raw data)
  • Validation Test / Test for Interfering Factors (aka Inhibition/Enhancement Test) (Gel Clot) (photometric method) - 3 Batches of Finished Products
  • Method
  • Result (raw data)
  • Validation Test / Standard Curve (Photometric Method)-1 Batch of Endotoxin
  • Method
  • Result (raw data)

• Sterility
  • Routine Test / Sterility Test
    • Method
    • Result
  • Routine Test / Growth Promotion Test
    • Method
    • Result
  • Routine Test / Test for Media Sterility
    • Method
    • Result
  • Routine Test / Preparation of Media
    • Method
    • Result
  • Validation Test / Bacteriostasis&Fungistasis Test
    • Method
    • Result
  • Summary of method validation
  • Protocol Validation, Other Documents

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

• 10. Guideline For The Submission Of Analytical Method Validation (AMV) Documents

Reference ASEAN Guidelines:

• ASEAN Guideline for Validation of Analytical Procedures
• ASEAN Guidelines for Validation of Analytical Procedures (Q&A)

Reference ICH Guidelines:

• Validation of Analytical Procedures: Text and Methodology (Q2)
• Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products -Chemical Substances (Q6A)

Please submit supporting document required during the evaluation

Please attach (if any) e.g. Letter of commitment to submit complete stability study or PV etc.