Sunscreen licensing: Australian manufacturers

The licensing of sunscreen manufacturers in Australia is under way. Conformance with the "Australian Code of GMP for Therapeutic Goods - Sunscreens" <http://www.tga.gov.au/docs/html/gmpsunsc.htm> is one of the criteria for issuing a licence (others include payment of associated fees and charges). Copies of this Code are available from the TGA.

Changes made last year to the Therapeutic Goods Act 1989 regulations made it an offence to manufacture sunscreens, other than those below SPF 4, without a licence.

Manufacturers who made a licence application before the end of June 1994, when the change to the regulation was given effect, were permitted to continue to manufacture without a licence until their application was determined. The industry was told that this determination would be made one way or another before July 1995.

Manufacturers who already held a relevant therapeutic goods manufacturing licence, in this case over 20, were not required to re-apply for a sunscreen licence.

Fifteen applications were made before the due date and were permitted to continue manufacturing. Two who applied after the due date have had to wait to be licensed before manufacture is permitted.

Four companies were unacceptable on the initial audit. One withdrew its application and ceased manufacturing sunscreens after the initial audit showed unacceptable non-conformance with GMP, including possible cross-contamination with potent veterinary preparations. Three were sent a warning letter indicating the consequences, that is refusal of application, if they failed another GMP audit. All subsequently withdrew their applications to concentrate on their core businesses.

Two marginal companies are moving to a new facility in late 1995 and may be given an extended period of grace to complete the transfer of manufacture. Three other applicants are completing new facilities and hope to be "on-line" before the manufacturing for the next summer season commences.

Five companies are either already licensed or in the process of being given final approval for a licence.

The remaining manufacturers are now in the process of being re-assessed to make a final determination on their applications.

Overseas sunscreen manufacturers

Sponsors who have their sunscreen products made overseas have now been asked to provide evidence that the manufacturing process conforms to the Australian Code of GMP for Therapeutic Goods - Sunscreens <http://www.tga.gov.au/docs/html/gmpsunsc.htm> or an equivalent Code. Guidance on forms of acceptable evidence has been provided and a period of grace of nearly 12 months has been advanced in order for them to comply.