Section E Generic

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 Contract 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 by another company (not by the manufacturer); where the owner is appointing the manufacturer to be the repacker of the product.

Reference :
Glossary Guidelines


E2.4 : Letter of Acceptance from the Repacker

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

Reference :
Glossary Guidelines

• Applicable for Imported Product only
• A certificate of pharmaceutical product of the type defined in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
• Must be issued by the competent authority in the country of origin. [CPP issued by EMEA for products registered through the centralized procedure in EU will be accepted]
• Shall be in the format of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce & be issued by the Health Authorities listed in the WHO Certification Scheme
• CPPs issued by the manufacturer or other authorities are not acceptable.
• If more than one manufacturer is involved in the manufacture of a product, GMP certification should be available for all the manufacturers
• In the event a CPP is not available from the country of manufacture (not licensed for sale in said country as manufacturing under contract only for product owner from another country), the following alternatives may be considered:
• GMP Certification / Manufacturing License for the manufacturer from the relevant competent authority, together with

(1)  CPP from the country of the product owner; OR

(2)  CPP from country of release, if (1) is not available

• To confirm the right product name, manufacturer and date of issuing whether the CPP is still valid or not (valid up to 2 years from date of issue)

• Applicable for Imported Product only where the CPP is unavailable and deemed acceptable by DCA for traditional medicines, dietary supplements and for external personal care products for medicinal purpose.
• Must be issued by the competent authority in the country of origin. CFS issued by EMEA for products registered through the centralized procedure in EU will be accepted

• Please submit valid GMP certificate.

Reference :
Glossary Guidelines

• Please select YES or NO. If YES, please select the manufacturer from the database list. Please select the processing steps involved e.g. Repacker.
• Attachment of GMP Certificate to conform the GMP standard of the other manufacturer.

• 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.

Please provide all product information/package insert as approved by the drug regulatory authority from DCA reference countries and ASEAN Member States.

Please provide the latest Company Core Datasheet (CCDS).

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)

• A list of all non-clinical and clinical studies and their corresponding GLP/GCP adherence status.
• A list/ declaration of all clinical studies conducted/ongoing/planned in Malaysia and further information regarding the study sites (hospital/institution), investigator, number of patients, trial duration (date start & end) and any other relevant info. If no locally conducted trials, to provide a declaration stating that there are no local trials.
• A list/declaration of named-patient use information for this product in Malaysia (to include the name of the requesting doctor(s), the hospital/institution, the number of patients and the quantity approved for use).

• Updated list of the worldwide registration status, including the regulatory status in DCA reference countries ASEAN Member States.

  -   To provide information on any rejection, withdrawal and deferral in any other country concerning the submitted product.

Please attach (if any).

Please attach (if any).