GMP clearance for prescription medicines
March 2008
The TGA's 16th edition of the "Guidance on the GMP Clearance of Overseas Medicine Manufacturers" became effective March 2008, and provides detailed information on how to obtain GMP clearance for overseas manufacturers. Enquiries should be emailed to gmpclearance@tga.gov.au.
Category 1 applications for new medicines
Any category 1 application submitted to the Drug Safety and Evaluation Branch (DSEB) for registration of a new medicine in which overseas manufacturing sites are involved should, where possible, be accompanied by current and relevant GMP clearance letters issued by the Manufacturers Assessment Section (MAS) of the TGA. If clearances have not been issued, the application may be submitted and copies of the clearances forwarded to DSEB as soon as they become available. Final approval of the application cannot be granted until the clearances are submitted and, if GMP clearance is not forthcoming, a rejection of the application is almost certainly inevitable.
Category 3 applications and self-assessable notifications
Any category 3 application for approval of a change involving overseas manufacturers or any self-assessable notification (SAN) of such a change must be accompanied by a current and relevant GMP clearance letter issued by the MAS, in addition to any other required supporting data for the change. Where a GMP clearance is required but has not been provided at the time of submission, the application or notification cannot be accepted for processing. Merely providing evidence or an assurance that relevant GMP certificates have been submitted to the MAS for the issue of a GMP clearance letter is not acceptable for this purpose.
Company name change with no change in site address
GMP clearance may also be required when an overseas manufacturer changes company name. Acceptable evidence of GMP, together with the new company name should be submitted to the MAS. Any GMP clearance letter issued by the MAS, together with a covering letter from the sponsor, should then be forwarded to the Information Technology (IT) Section of the TGA with a request to update the client database in SIME. This will ensure that ARTG entries for the products concerned include the new company name.