Qualified Person, Responsible Person & RPi Services
Qualified Person services as per Directive 2001/83/EC
- KeyQP can provide Contract Qualified Person services (Contract QP) where Qualified Person has obtained QP Qualification under Permanent Provision of 2001/83/EC and are approved on MIA licence by MHRA and other EU Authorities.
- They have experience of Medicinal product Release / Certificate in the UK or EU in different dosage forms such as non-sterile, sterile, and parallel imported products.
Act as Responsible Person (RP) as per GDP requirements (2013C/ 343/01)
- KeyQP can provide Contract Responsible person (Contract RP) services via Cogent Gold standard approved Responsible Persons who are approved on WDA licences by MHRA and other EU Authorities.
- They have experience of full filling RP duties in UK and other EU Authorities. They can handle authorised medicinal products, Unlicenced medicinal products, export to EU or Rest of the world, medical devices etc.
Act as Responsible Person Import (RPi) in UK from Jan. 2021.
- KeyQP can provide Contract Responsible person Import (Contract RPi) services through persons having Qualified Person status in the UK. They are approved as RPi on WDA licences granted by MHRA.
- They have experience of full filling RPi duties in the UK alongside implementation of quality system for it when medicinal products are imported from EU/ Approved country list in the UK.
