Exporting Medicines from Australia – TGA Certification Requirements

Purpose of Export Certificates

Export certificates assist Australian sponsors and manufacturers in meeting overseas regulatory or customs requirements by certifying:

• The medicine is included in the Australian Register of Therapeutic Goods (ARTG) and lawfully supplied in Australia, or
• The medicine has been manufactured and tested in accordance with Australian standards (for products not supplied locally).

Common certificate types:

• Certificate of Pharmaceutical Product (CPP) – aligns with WHO format.
• Certificate of Free Sale (CFS) – confirms free availability in Australia.
• Certificate to Foreign Government – attests to compliance with Australian requirements.

Eligibility and Product Categories

• Registered medicines (prescription, OTC assessed): Eligible for CPP or CFS if included in ARTG.
• Listed medicines: Eligible for CFS if included in ARTG.
• Exempt medicines: May qualify if manufactured under GMP and meet relevant standards.
• Biologicals and therapeutic goods: Specific rules apply; some require additional evidence.

Devices and biologicals follow separate export pathways.

Application Process

• Submit via TGA Business Services online portal.
• Required information:
  • ARTG entry number (if applicable).
  • Product name, active ingredients, dosage form, strength.
  • Batch details (if batch-specific).
  • Destination country and importer details.
  • Requested certificate type/format.
• Upload supporting documents (e.g., GMP certificate, ARTG extract).
• Pay applicable fee (standard or priority processing options).
• TGA reviews for completeness, compliance, and accuracy.

Processing and Issuance

• Standard timeframe: 20 working days.
• Priority service available for urgent requests (additional fee).
• Certificates issued electronically (PDF) with TGA electronic signature.
• Validity typically 2 years or tied to ARTG inclusion/GMP certificate expiry.

Key Obligations and Notes

• Sponsors must ensure ongoing compliance; changes to ARTG or GMP may require reapplication.
• TGA does not verify or guarantee acceptance by foreign authorities.
• False or misleading information may lead to refusal or revocation.
• For products not in ARTG, additional evidence of GMP and quality control required.
• Maintain records of exported batches for traceability.

Detailed eligibility by product type, certificate formats, required documents, fee schedule, processing timelines, country-specific requirements, and application checklists are outlined in the TGA guidance on exporting medicines. Source: Exporting medicines - TGA

This certification process supports Australian medicine exporters while upholding regulatory standards for international markets.