Does a shareholding change or change of directors at a company holding a pharmaceutical licence need to be reported to the Department of Health?

Yes, it must be notified. A pharmaceutical licence is issued to a specific corporate entity, and the regulatory authority pays close attention to the individuals who control and manage that entity. Any change that may affect the company's control or management must therefore be notified to the Drug Office, Department of Health, in a timely manner. For a “Wholesale Dealer Licence” or a manufacturer's licence, if the company's directors change or there is a significant change in its shareholding structure (for example, a change of controlling shareholder), the licence holder is responsible for notifying the Drug Office in writing within a reasonable time after the change. For a licence as an “Authorised Seller of Poisons (ASP)” (pharmacy), the licence is linked to a specific “Authorised Person” (usually the company itself) and the pharmacist responsible for management, so any change of director should be reported immediately. In addition, if a pharmacy business is transferred to another company, the new operator must apply for a new licence because licences are not transferable.