The new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) was published on 3 October 2017. This version replaces its 2004 predecessor. Sponsors were given a familiarisation period of three months and the URPTG came into effect on 15 January 2018.
What hasn't changed?
For the large part, the procedures for undertaking a recall and non-recall action of therapeutic goods have remained unchanged.
The four levels of recall are still classified as follows:
- wholesale level;
- hospital level;
- retail level; or
- consumer level.
The levels of risk have also remained unchanged, the highest being Class I (serious safety-related), followed by Class II (urgent safety-related) and Class III (lowest risk).
Some of the key changes in the new URPTG include:
Two types of recall actions have been introduced:
Product defect correction: The previous recall action for 'product correction' has been replaced with 'product defect correction'. A 'product defect correction' is undertaken to correct a specific or potential deficiency. It includes:
- the repair, modification, adjustment or re-labelling of therapeutic goods for reasons relating to deficiencies in quality, safety, efficacy, performance or presentation;
- corrections involving a product's expiry date; and
- updates or changes to any accessories, operating instructions or software.
Product defect alert: 'Product defect alerts' are available for use in instances where discontinuation of treatment may be riskier than the continued use of the deficient product. For example, this may occur where there are no alternative products available or where a recall action will result in an interruption of patient treatment or a medicine shortage. A product defect alert may be followed by a recall once unaffected or alternative products become available.
The previous non-recall action for 'recovery' by the sponsor has been replaced by the definition of 'quarantine'. A 'quarantine' suspends further supply pending investigation of an issue or incident. The outcome of the investigation will determine further actions, including a recall, if necessary.
Minor amendments have been made to the other types of non-recall actions, being, 'safety alert', 'product notification' and 'product withdrawal'. However, the overall meanings remain largely unchanged.
Although compliance with the URPTG is not mandatory, it is highly recommended that it is followed. Sponsors face the risk of civil and criminal penalties for non-compliance of mandatory recall procedures.
Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries. www.dentons.com.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.