If a company holding a pharmaceutical licence undergoes a major shareholding change, such as being acquired by another company, must it reapply for the licence?

This depends on the circumstances, but a completely new application is generally not required; instead, strict notification and approval procedures must be followed. When a licensed company undergoes a major shareholding change or transfer of control, the legally licensed entity (that is, the company as a legal person) remains unchanged, so the licence itself remains valid. However, the company must immediately notify the Drug Office, Department of Health, in writing of this major change. The new major shareholders, directors and ultimate beneficial owners must submit their personal particulars to the Pharmacy and Poisons Board (PPB) and undergo a “fit and proper person” assessment. The PPB must be satisfied that, under the new control, the company can and will continue to comply with all licence conditions. In some cases, if the PPB has concerns about the new shareholders’ background or intentions, it may impose additional licence conditions or conduct inspections more frequently.