Certificate of Listed Product, Certificate of Pharmaceutical Product and Certificate of Exempt Product
Sponsors of listed medicines which have been approved for supply in Australia have the choice of either requesting a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Product (CLP). A CLP is similar in format to a CPP but is not issued under the WHO Certification Scheme On the Quality of Pharmaceutical Products Moving in International Commerce. The CLP includes a statement from the TGA regarding the legal status of the product on the Australian market and omits the "on the market" question.
The CPP has comment boxes for sponsors and the TGA. A standard range of comments are available for sponsors to clarify reasons as to why a product has been approved but is not "on the market". The Certificate of Listing, stating the conditions imposed on the product, and the TGA comment box on the CPP and CLP, is used by the TGA to communicate any additional information to overseas regulators which is relevant to the product. This Export Advisory Procedure has generally replaced the earlier process which, in cases where required, involved seeking approval of importing country prior to listing the product. Authorities in the importing country are now contacted, prior to listing, only where the TGA has serious safety concerns regarding the product to be exported.
Certificate of Exempt Product is issued for products, which are exempt from the requirement of entering in the Australian Register of Therapeutic Goods (ARTG) but still subject to therapeutic legislation. It is not issued under the WHO Certification Scheme On the Quality of Pharmaceutical Products Moving in International Commerce, however, it is designed in accordance with the WHO model, for exempt medicines that are manufactured in a GMP licensed manufacturing facility. The Therapeutic Goods Regulations 1990 Schedule 5 has more details regarding the products that are exempt from the requirement of listing in the ARTG.
What will TGA certify?
As a matter of general principle, the Export Unit only certifies documents, as schedules to CPPs or CLPs, that it can verify. Therefore certification is limited to the following documents only:
- formulation details;
- manufacturing details;
- labels for finished products; and
- product information which is the same as that approved by DSEB for a product registered in the ARTG.
It is not appropriate for the staff of the Export Unit to certify certificates of analysis, methods of analysis, product specifications, raw material specifications or a copy of the TGA manufacturing licence as they are not certifiable under the WHO scheme. This approach is consistent with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom which only certifies specific information in the Product licence (eg product information) and the Food and Drug Administration in the United States which only certifies manufacturing details and product labels.
However, the abovementioned documents, if required by regulatory authorities in the country of import (such as the United Arab Emirates), may be submitted for stamping as "Seen by TGA" Additional documents which may be stamped as "Seen by TGA" include test methods, shelf life and storage conditions (where these details are not part of the ARTG record) and product information which has not been approved by the TGA (eg for products listed for supply in Australia). At the same time, the Export Unit will endeavour to keep such export destinations informed on the relevance of these documents in the context of the Australian system and the WHO Scheme.
It is hoped that these changes will facilitate trade, enhance the timeliness of the export approval process and refocus the activities of the Export Unit.