Qualified Persons

The United Kingdom pharmaceutical industry has set high standards of research, development, manufacturing and testing of its products in order to promote the healthcare of patients.  The key factor in the success of the pharmaceutical industry is the quality of the people it employs and the training it provides to ensure the maintenance of the established high standards.  A Qualified Person, who is responsible for certifying the suitability for release of medicinal products as part of this industry, requires specialised training and experience in order to fulfil the requirements.

The Medicines and Healthcare products Regulatory Agency (MHRA) of the Department of Health and the Veterinary Medicines Directorate (VMD) of the Department of the Environment, Food and Rural Affairs (DEFRA), require the Society of Biology, the Royal Pharmaceutical Society of Great Britain and the Royal Society of Chemistry to assess the eligibility of their members for Qualified Person status.

Please refer to the following documents when making an application for certification as a Qualified Person:

• Application form
• Guidance Notes for Applicants and Sponsors
• Study Guide
• Code of Practice for Qualified Persons
• Sponsor Form

The documents collectively aim to provide detailed information on the requirements for certification and the application process. Applicants should contact the officer at their respective professional body if further information is required.