The Qualified Person (QP) Role is well established for certification of medicinal products in the European Union (EU) and European Economic Area (EEA). It was first introduced in EU Directive 75/319/EEC, replaced with Directive 2001/83/EC and most recently further defined in Annex 16 of the EU Good Manufacturing Practice (GMP) guidelines. The QP plays a critical role ensure the quality and safety of Medicinal Products in both the EU and wider markets when medicinal product is released from within the EU.
Some may ask: “why involve an EU QP when product is destined for the UK Market, which, as of 01 January 2021 left the EU?”. The answer can be simple if the product is supplied direct to the UK from outside the EU, no EU QP involvement is necessary.
If however the supply chain requires import of medicinal product to the EU, followed by release to the UK market, certification from an EU QP is necessary because once a medicinal product is imported to the EU, regulations (specifically Annex 21 of the EU GMP guide) require batch certification from an EU QP once the product has been physically imported, even if the final destination of the product is outside of EU/EEA.
Instead of duplicating QP responsibility and potentially delaying supply of medicines, legislation was introduced in the UK to create the role Responsible Person (import) RPi which allows recognition of EU/EEA QP certification and release under wholesale dealer arrangements.
The RPi is named on a specific WDA(H) licence based on their qualifications and experience. They are responsible to ensure supply chain security by checking the batch of medicinal product has been imported from an approved country and confirmation of QP certification including independent batch release certificate for biological products.
Medicinal Products often have complex supply chains, requiring specialised qualified services all of which are highly regulated, the introduction of an RPi has been an effective solution, to leverage from existing controls of EU QP release and avoid supply disruption.
MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. MIAS Pharma provides Commercial QP solutions, WDA support and Marketing Authorisation support. In 2023 MIAS Pharma is expanding to extend these services to the UK market also.
MIAS can develop tailored strategies and procedures to meet the importation requirements and maintain high-quality standards for imported medicinal products.
Get more information about our QP services here.
For any questions get in touch with us at info@miaspharma.com
