Veterinary biologics and pathogens

"Veterinary biologics" means any viruses, serums, toxins and analogous products of natural or synthetic origin, including genetically modified organisms, diagnostics, antitoxins, vaccines, live micro-organisms, killed micro-organisms and the antigenic or immunizing component of micro-organisms intended for use in the diagnosis, treatment or prevention of diseases of animals and birds, or for purposes of research in animals or birds.

Regulation of vet biologics is part of AVA's role in safeguarding the health of animals and birds.

1. Registration before import application, namely licensing for possession of veterinary biologics (veterinary vaccines; and pathogens on AVA's select list) and registration of new vaccines;
2. Application for Licence (for every consignment);
3. Inspection and Sampling (where applicable); and
4. Audits of licensed premises.

1. His/Her qualifications;
2. Nature of company business,
3. Research work (brief description), if applicable;
4. Information on item(s) to be imported;
5. Purpose of import;
6. Site of operation;
7. Mode of transportation to storage premises;
8. List of customers, if applicable;
9. Name and qualifications of personnel involved in handling the items; and
10. Standard operating procedures (SOPs) for the handling and disposal of biohazardous materials (including the usage and type of personal protection equipment, waste treatment and pest control).

The application may be submitted to the Licensing Division, Agri Establishment Regulation Department, Agri-Food and Veterinary Authority at 75, Pasir Panjang Road, Singapore 118507 (Attn: Dr Joanna Khoo).

1. Table of Content
   
2. Product and Manufacturer Information
   1. Name of product and product code number;
   2. Description of product with specimen label, product insert and packaging label;
   3. Composition of product, including history/source of master seed;
   4. Name and address of manufacturer;
   5. Copy of the licence to manufacture the product granted to the manufacturer by the relevant authority of the country of manufacture;
   6. Other supporting documents, such as:
      • Product registration certificates
      • GMP certificates
      • Certificates of free sale
      • Document from relevant authorities, certifying that: "ingredients of bovine origin used in veterinary biologics must be obtained from countries where there are no cases of BSE"
      • A list of all ingredients of animal origin used in the production of the biological products from the manufacturer. The list should contain information such as name of the material and the country of origin.
        
3. Outline of Production (including potency test or immunogenicity test of master seed)
   
4. Quality Control Tests with Full Description
   1. Sterility test
   2. Purity test
   3. Inactivation test (for inactivated vaccines)
   4. Safety test
   5. Efficacy/Potency test
   6. Specimen copy of the quality control certificate for each batch of the product.
      
5. Developmental Studies (Summary Reports)
   1. Safety studies:
      • Safety of multi-doses in target animals at minimum age of application
      • Inoculation site reaction
      • Transmissibility of master seed virus (live vaccine) to non-target species
      • Reversion to virulence of vaccine
   2. Inactivation test for inactivated products
   3. Stability studies under proposed storage conditions
   4. Efficacy studies:
      • Challenge protection in target species
      • Correlation studies (for non-challenge studies)
      • Duration of immunity
      • Compatibility studies with other vaccines, treatment or conditions (where applicable)
      • Effects of maternal antibody level and annual booster dose (where applicable)
   5. Field trials of the final product, especially for safety and efficacy.
   6. Other studies (where applicable):
      • Residue study
      • Occupational health and safety study
      • Environmental risk study

Import licence of veterinary biologics and AVA's veterinary conditions

An AVA import licence is required for each import of veterinary biologics (veterinary vaccines; and pathogens on AVA's select list). For application to import, the applicant must have a licence to possess veterinary biologics.

Veterinary vaccines
Please submit your application for an import licence online, via the AVA website: http://www.ava.gov.sg/Services/LicensesPermitsAndCerts/Permit_Import_Export_Transship_Animals_Birds_Eggs_Biologics.htm.  You will need a SingPass if you are a Singapore citizen or Permanent Resident before you can make the application.  If you are a foreigner, you can make your application by using the foreign link provided.  An application number will be given after the application is submitted or saved as draft.  Retain the number, as you will need it to resume the draft application, enquire on your application status, make payment online, or download/print your licence from eCLiPS after fee payment.  The fee for the import licence is S$22 per consignment and is valid for 30 days.

Generally, a complete application (with necessary supporting documents and prior approval of storage/research premises) will be processed 2 working days after receipt of the application. Any incomplete or incorrect submission may result in a delay in the processing time. If the licence is required within 2 working days, an express service fee of an amount equivalent to the licence fee will be charged, in addition to the licence fee.

Pathogens on AVA's select list
For pathogens on AVA's select list, application for an AVA import licence is made through the TradeNet system.  A declaration for items which have been imported previously will generally be processed one working day following receipt of necessary supporting documents (eg. letter of authorization, product specification, certificate of analysis, etc.); and payment (for non-GIRO applicants).  In the case of pathogens which will be imported for the first time, a risk assessment will need to be submitted for import consideration, and prior approval from AVA must be obtained before making the application at TradeNet.  The import licence fee is S$22 per consignment.

Applications to register or import new pathogens should be submitted to AVA.  Applicants are advised to submit their applications at least 1 month before the proposed import.

The import of veterinary biologics (veterinary vaccines; and pathogens on AVA's select list) must comply with AVA's Veterinary Conditions.  For the veterinary conditions to import, please select:

(a)    Vaccines
        1.    Final Labelled Products
        2.    Bulk/Unlabelled Products
        3.    Seeds/Samples    

(b)    Micro-organisms of animals and birds
        1.    Type Cultures/Stains
        2.    Laboratory Isolates

(c)    Viruses of animals and birds
        1.    Type Cultures/Strains
        2.    Laboratory Isolates