The Qualified Person (QP) is essential to the safe control of medicines and needs to have extensive training and in-depth critical understanding of all the aspects associated with pharmaceutical manufacturing.
The primary legal responsibility of the Qualified Person (QP) is to certify batches of medicinal products prior to use in a clinical trial (human medicines products only) or prior to release for sale and placing on the market (human and veterinary medicinal products).
The Medicines and Healthcare products Regulatory Agency (MHRA) of the Department of Health and the Veterinary Medicines Directorate (VMD) of the Department for Environment, Food and Rural Affairs (DEFRA) require the Royal Pharmaceutical Society, the Royal Society of Biology and the Royal Society of Chemistry to certify the eligibility of their members for nomination as a Qualified Person.
The MHRA / VMD are responsible for determining who can be named as a Qualified Person on a Manufacturer's Authorisation.
The MHRA has issued information for Transitional IMP QPs (named as a QP in a valid application for a manufacturing authorisation for IMPs made prior to 1st May 2006 under the Medicines for Human Use (Clinical Trials) Regulations 2004). Further details are available on the MHRA website.
An online network has been set up for all members interested in Qualified Persons including anyone interested in becoming a QP and members listed on the RPS register of Eligible QPs.
Joint Professional Bodies Qualified Persons’ Scheme
Please refer to the following Application 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
Additional information is in our Frequently asked questions
Updated Application Documents have been launched (February 2017). The study requirements have not changed. We updated the documents to include new terminology and to provide more advice. We encourage you to now be using the new documentation but currently, for a short period, will accept applications using the previous version of application form and/or sponsor form.
The fee for all applications under the Permanent Provisions (category A) is £600.
If further information is required, applicants should contact the officer at their respective professional body. For information relevant to members of the Royal Pharmaceutical Society please choose from these options:
For general QP enquiries
Some educational establishments and commercial providers run courses aiming to equip prospective candidates with the body of knowledge set out in the Study Guide. It is not compulsory to take any course, and the Joint Professional Bodies do not accredit or endorse training courses. It is for you and your sponsor to decide on how to prepare for assessment, which may or may not include attendance at formal training courses.
A list of training course providers is provided for information only.