The Australian regulator, the Therapeutic Goods Administration (TGA) and Department of Foreign Affairs and Trade (DFAT) recently announced that the Vietnam Food Authorities (VFA) have agreed to accept Certificates of Pharmaceutical Product (CPPs) or Certificates of Listed Product (CLPs) for supplement products from Australia.
Previously, there were uncertainties surrounding export certification requirements, especially since certain supplements and complementary medicines that were regulated as therapeutic goods in Australia were regulated as foods in Vietnam.
The VFA had rejected CPPs and CLPs and instead requested Certificates of Free Sale (CFSs), which the TGA was unable to provide.
This sparked multiple rounds of discussions between Australia and Vietnam, after which the VFA finally agreed to accept CCPs and CLPs in place of CFSs, so long as the CLPs or CPPs in questions contained the necessary information stipulated in Vietnamese law to satisfy the requirements for export into the country.
Notably, the approvals for products that had previously been issued with a CFS by Australia’s Department of Agriculture, Water and Environment (DAWE) or State and Territory Chambers of Commerce need not be revoked.
Vietnamese requirements for Aussie supplements
Under the VFA’s legislative requirements for certification, a CLP must contain the name of the issuing authority, the certificate number and date of issue, the eligible goods and which category they fall under, the manufacturer’s name and address, and the full name and signature of the certificate’s signatory, as well as the seal of the issuing authority.
The CLP must also contain a clear indication that the goods were produced and are being freely sold in the market of the country of production or the country by which the certificate is issued. Presently, the CLP fulfils all but one of the aforementioned requirements — the “type or category of goods eligible”, for which the VFA has three supplement categories: health supplement, dietary supplement and food supplement.
To meet this requirement, the TGA has proposed using the sponsor comment field on the certificate to denote the product category, as the TGA itself cannot advise which product category should be listed on the export certificate. This would require the sponsor to provide this information when applying to the TGA for the CLP.
What’s next?
Currently, the TGA is updating its guidance document, Export of Medicines from Australia, to include information about the CLP application process, and instructions on how to include sponsor comments on product categories in applications specifically for export to Vietnam.
At present, each applicant must submit a Word document as an attachment to their application, specifying the product category as per VFA requirements. The TGA is at the same time working on the best way to automate this process through the online form, and will consult with Complementary Medicines Australia (CMA) before making a final decision.
