📘 Regulatory basis
The person responsible is one of the core elements of a pharmaceutical licence application. Without a qualified person responsible, the applicant entity is no longer complete and the application process must be suspended. This reflects the regulator’s recognition of the critical role of people in a quality system.
📗 Drew Tang's recommendations
To deal with this unexpected situation, we recommend appointing and training one or two deputy RPs at the start of the project. If the RP leaves, you can immediately apply to the Department of Health to appoint the most experienced deputy RP as the formal RP. As this deputy RP’s details will already have been submitted with the application and they will already have received training, the Department of Health’s review is likely to be much faster, minimising delays caused by personnel changes.
📕 Risk notice
The greatest risk is “delay” and “concealment”. If you try to conceal the fact that the RP has left, or delay appointing a new RP, your application may ultimately be refused on the grounds that you “cannot meet the basic requirements”. This not only wastes all the time and resources invested so far, but also seriously damages your credibility with the regulator.