Protecting the UK medicines supply chain

Under good distribution practice (GDP), distributors of medicinal products have a key responsibility in preventing falsified medicines entering the legal supply chain. Weak due diligence checks on customers and suppliers increases the risk of falsified medicines entering the legal supply chain and causing serious risk to public health.

Falsified Medicines Directive

The Falsified Medicines Directive (Directive 2011/62/EC) was published to prevent the entry of falsified medicinal products into the legal supply chain. The Commission Delegated Regulation (EU) 2016/161 was later published and set out detailed rules for safety features to appear on the packaging of medicinal products intended for human use; a unique identifier in the form of a 2D barcode and an anti-tamper device as well as the establishment of a medicines verification system to decommission packs prior to dispensing. With the abandonment of the UK National Medicines Verification System for Great Britain from 1 January 2021, which was a key part of the Falsified Medicines Directive (FMD), this has left Great Britain vulnerable. FMD remains active in Northern Ireland.

There is always a degree of risk when adding a new supplier, or when an existing supplier is expanding their product range. Many offers look too good to be true and some cases may be genuine. High-value, low-turnover products that are intended for supply to hospitals pose a particularly high risk. Any unsolicited offers for products should be treated with extra caution, particularly where a supplier appears eager or pressured to sell the stock quickly.

medicines supply chain - hospitals

Unregistered Brokers

The MHRA are seeing cases of unregistered brokers soliciting transactions between legitimate wholesalers. Representatives were negotiating deals between licence holders and taking a commission for those services. They were not registered as a broker and therefore anyone found using their services had breached the conditions of their wholesale dealer’s licence. If using brokers, always implement and conduct independent checks on their registration status.

There have also been cases seen where call centres based outside the UK are being employed to conduct telesales on behalf of UK wholesalers. Any activities of procurement and supply must take place on sites named on a wholesale dealer’s licence. Therefore, procurement and sales offices outside the UK is NOT compliant with GDP and puts you in breach of your licence if using these services.

medicines supply chain - call centre

The importance of a Quality Management System

The implementation of robust customer and supplier qualification procedures within your Quality Management System provides reassurance that medicinal products are being procured from reputable sources and are only supplied to customers who themselves are authorised to be in possession of medicines.

When conducting due diligence checks, a company should not rely on information solely provided by the supplier. There is the risk of illegally obtained or falsified documentation being provided. You should also be careful of who you share copies of your own licences with, if asked. The MHRA has published a blog which outlines questions to consider when receiving suspicious offers for medicinal products. They have previously published guidance on qualification of suppliers, customers, phishing emails, and fraudulent websites.

Effective stock control and proactive reporting of loss/stolen items is also crucial to preventing falsified medicines being sold on. Always remain vigilant, sign up for MHRA alerts and staff should be trained and aware to report anything suspicious to the Case Referrals team within the MHRA.

Avoid putting your company at risk. Failure to identify and report suspicious activity to the MHRA will lead to regulatory action being taken against your licence, which may lead to licence suspension and/or removal of the responsible person (RP).