Ireland

Pharmaceutical companies engaged in the selling of medicines must hold a Wholesale Distribution Licence (WDL). In order to obtain the WDL the pharmaceutical company must satisfy Health Products Regulatory Authority (HPRA) that it has a sufficient Quality System including the named ‘Responsible Person’. The legislation doesn’t require that the Responsible Person has a specific qualification but HPRA will require evidence of sufficient educational qualifications and experience.

Our team of experts at JensonR+ Limited can support you with:

• Prepare a set of SOPs which describe quality relevant processes
• Supervise a set of Technical Quality Agreements tailored to your specific situation
• Assist you during the inspection