Frequently Asked Questions
Find answers to the most common questions about Good Distribution Practice, MHRA compliance, and our consultancy services.
Whether you are new to pharmaceutical wholesaling or an experienced operator looking to strengthen your compliance, our FAQ section covers the essentials. If you cannot find the answer you are looking for, please get in touch and we will be happy to help.
Good Distribution Practice (GDP) is a quality system for the proper distribution of medicinal products for human use. It ensures that the quality and integrity of medicines is maintained throughout the supply chain, from the manufacturer to the pharmacy or person authorised to supply medicines to the public. GDP is a legal requirement in the UK and EU, enforced by the MHRA.
A Wholesale Dealer Authorisation (WDA) is a licence issued by the MHRA that permits the holder to distribute medicinal products by way of wholesale dealing. Anyone who procures, holds, supplies, or exports medicinal products needs a WDA (or WDA(H) under Human Medicines Regulations 2012). Without this licence, it is illegal to wholesale medicines in the UK.
A Responsible Person (RP) is the individual named on a Wholesale Dealer Authorisation who is responsible for ensuring that the conditions of the licence are met. The RP must have appropriate qualifications and experience, and must ensure GDP compliance at all times. Under UK law, every WDA holder must have a named RP.
Yes. If you do not have a suitably qualified person in-house, you can appoint a Contract Responsible Person. Paradigm Shift Consulting provides Contract RP and Deputy RP services, offering named RP support via phone, email, and regular on-site visits. This is a cost-effective solution that ensures full regulatory compliance.
An MHRA GDP inspection typically involves a review of your quality management system, documentation, premises, equipment, and operations. Inspectors will examine your SOPs, training records, temperature monitoring, complaint handling, and recall procedures. The inspection usually takes 1-3 days depending on the size of your operation. Paradigm Shift can help you prepare through pre-inspection audits.
MHRA classifies deficiencies found during inspections into three categories: Critical deficiencies pose a serious risk to public health and may result in immediate suspension of your licence. Major deficiencies indicate significant non-compliance that could potentially affect product quality. Other (minor) deficiencies are lesser issues that should be addressed but do not immediately threaten product quality or public health.
The cost varies depending on several factors including the MHRA application fee (currently around GBP 3,000-4,000), the cost of preparing your premises, documentation, quality management system, and consultant fees if applicable. Paradigm Shift can provide a tailored quote based on your specific circumstances and help ensure your application succeeds first time.
Yes. Pharmacies involved in wholesale distribution activities must comply with GDP requirements. This includes pharmacies that supply medicines to other pharmacies, care homes, or healthcare providers. The level of GDP compliance required depends on the scale and nature of the wholesale activities being conducted.
We offer comprehensive GDP training for all staff levels, available both face-to-face and online via gdptraining.co.uk. Our courses cover all aspects of Good Distribution Practice, from introductory awareness training to advanced RP preparation. Training can be tailored to your specific operational needs and delivered at your premises.
You can verify supplier compliance by checking the EudraGMDP database maintained by the European Medicines Agency, which lists all authorised wholesale distributors. You should also conduct due diligence checks including requesting copies of their WDA, reviewing their compliance history, and potentially conducting supplier audits. Paradigm Shift can assist with supplier qualification processes.
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