Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
D. Crisis management (including tampering of therapeutic goods)
A crisis is an unprecedented set of circumstances which represents an immediate and significant threat to a company, consumers of its products, employees and/or the community. This may include threats to the product, damage to the public image/reputation of a company or its products or a disruption of the production process. Such events are likely to attract media interest.
"Crisis Management Guidelines" have been developed by the Australian Self Medication Industry (tel 02 9922 5111, fax 02 9959 3693, ASMI website) in consultation with Medicines Australia, the Complementary Healthcare Council of Australia, the Medical Industry Association of Australia, Consumers' Health Forum, the Therapeutic Goods Administration, State and Territory Health Departments and Police Departments.
Companies are urged to implement these Guidelines as quickly as possible and to ensure that the appropriate personnel are trained in their operation.
Tampering of Therapeutic Goods - All threats of criminal tampering with a company's products should be considered to be genuine and therefore serious and be immediately reported to the Australian Recall Co-ordinator. (There is also a legal obligation to report such matters - see Section K). The Australian Recall Co-ordinator will convene a Crisis Reference Group (CRG) which will co-ordinate the activities required to resolve the crisis.
For any tampering crisis, the CRG will comprise:
The Australian Recall Co-ordinator nominated in the Uniform Recall Procedure for Therapeutic Goods;
The State or Territory Health Department Recall Co-ordinator nominated in the Uniform Recall Procedure for Therapeutic Goods;
The appropriate State Police officers nominated for this purpose by the Police Ministerial Council; and the senior personnel of the company concerned.