Section E Veterinary Medicines

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

• Applicable for Imported Product only
• CPP is mandatory for sterile preparations
• 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 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
    • CPP from the country of the product owner; OR
    • CPP from country of release, if (1) is not available
  • Unless otherwise supported by justifications acceptable to the Authority, the following products are unlikely to be registered:
    • products not licensed/ certified for sale in the country of manufacture/ product owner;
    • products manufactured for export only (imported products).

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

• The certificate shall be valid and current at the time of submission 

E3.2 CPP Issuing Body

• Competent Authority who issued the CPP as stated on the CPP
• Check for the competent Drug Authority
• Please select from list of database. If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

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

• Please select YES or NO. If answer is ‘NO’, please specify the reasons 

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

• Please select YES or NO. If answer is ‘NO’, please specify the reasons

E3.5 Date of issue of CPP

• As stated on the CPP

E3.6 Date of expiry of CPP

• As stated on the CPP

• Applicable for Imported Product (Type B) only where the CPP is unavailable and deemed acceptable by DCA.
• 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

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

• The certificate shall be valid and current at the time of submission

E4.2 CFS Issuing Body

• Please select from list of database the competent Authority who issued the CFS as  stated on the CFS .
• If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

E4.3 Date of issue of CFS

• As  stated on the CFS

E4.4 Date of expiry of CFS

• As  stated on the CFS

• Applicable for Imported Product only.
• If more than one manufacturer is involved in the manufacture of a product, GMP certification should be available for all the manufacturers.
• Check for the competent Drug Authority issuing the cGMP, at this website: http://www.whocc.no/atcddd/
• Authority will usually recognize GMP Certification/ Manufacturing Licence issued by the relevant national or regional Veterinary Service or Department of Animal Health or Department of Agriculture

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

• The certificate shall be valid and current at the time of submission

E5.2 GMP Issuing Body

• Please select from list of database the competent Authority who issued the cGMP as stated on the cGMP .
• If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

E5.3 Date of issue of GMP

• As stated on the GMP certificate 

E5.4 Date of expiry of GMP

• As stated on the GMP certificate 

Rereference :
Glossary Guidelines

• Manufacturer Name
• Manufacturer Address
• Processing Step
• GMP Certificate
  • Please enter name of company and click button ‘search’ to select other manufacturer (e.g. repacker) listed in the database.
  • For a new other manufacturer (repacker) which is not listed in the database search, please click ‘Not Listed Manufacturer’ button.
  • Please select from processing type drop-down list, e.g. assembly, packing, production, labelling, fill and finish, others.

• 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.

• For Imported Product only
• Please attach (where applicable)
• Product information as approved by the drug regulatory authority(The SmPC serves as the source of information for health personnel as well as for consumer information on labels and leaflets of pharmaceutical products and for control of advertising
• Information must be in line with the Package Insert

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

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.

Please refer

• Appendix 10: Guidelines for the Submission of Protocol of Analysis and Analytical Method Validation Documents, Registration Guideline of Veterinary Products (REGOVP).

*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.

Please refer

• Appendix 10: Guidelines for the Submission of Protocol of Analysis and Analytical Method Validation Documents, Registration Guideline of Veterinary Products (REGOVP).

Please submit supporting document required during the evaluation

• For imported product ONLY

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