What specific requirements apply to the physical facilities of premises (such as a warehouse or shop) when applying for a pharmaceutical licence?

When applying for a pharmaceutical licence, the premises' physical facilities are a key focus of the Department of Health's assessment and must meet stringent standards to ensure medicine quality and safety. A wholesaler's warehouse must meet GDP requirements, including sufficient space for segregated storage (such as areas for quarantined goods pending examination, released goods, returned goods and recalled goods); smooth, easily cleanable walls, floors and ceilings; equipment for continuous monitoring and recording of temperature and humidity, particularly for medicines requiring cold-chain storage; and a reliable security system to prevent unauthorised access and theft. Retail pharmacies must have a separate dispensing area with sufficient space and work surfaces. Prescription medicines must be kept in an area inaccessible to the public, preferably in locked cabinets or drawers. A suitable refrigerator must be provided for medicines requiring refrigerated storage, and a security system must also be installed. All premises must be kept clean and tidy, with appropriate pest control measures.