Section E Biologics

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.

E2.3 :  Letter of Acceptance from Contact Manufacturer (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

E2.4 : Letter of Acceptance from the Repacker

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

This manufacturer shall be the one who releases the product.

• 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

• Store Name
• Store Address

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

Please provide the latest Company Core Datasheet (CCDS) (if available)

Please submit supporting document required during the evaluation

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

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

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

Please refer:

EMEA/410/01 Rev. 3: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.