Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
How to be a Broker in Good Distribution Practice
How to be a legitimate Broker of Pharmaceutical Products
If you are interested in becoming a licensed broker in the pharmaceutical industry, you need to be aware of the legal and quality requirements that apply to your activities.
Brokers are intermediaries who arrange transactions between buyers and sellers of medicinal products, but do not take physical possession of the products or own them at any point. They can operate within the UK, within the EU, or between the UK and third countries, depending on the type of products and the market conditions. It should be recognised that brokers do NOT require a registration outside of the UK and EU, however it does add a degree of trust that other middlepersons will lack.
Legal Requirements
Brokers are subject compliance with the Human Medicines Regulations 2012 (HMR2012) , which implement the EU Directive 2001/83/EC and its amendments.
According to these regulations, brokers must:
- Register with the Medicines and Healthcare products Regulatory Agency (MHRA) before starting their activities. This highly complicated registration process involves providing information about the broker’s identity, contact details, scope of activities, and a full quality system including relevant SOPs, forms and logs. The MHRA maintains a public list of licensed brokers on its website.
- Comply with the relevant principles and guidelines of Good Distribution Practice (GDP) which aims to ensure that the quality and integrity of medicinal products are maintained throughout the supply chain. GDP covers aspects such as personnel, premises, equipment, documentation, operations, subcontracting, complaints, recalls, transportation, and risk management, however the broker is primarily responsible for ensuring that there are procedures for emergency recall, action in the event of falsified medicines, handling complaints, ensuring brokered products have a Marketing Authorisation, and a procedure for the qualification of customers and suppliers.
- Report any suspected falsified medicinal products or serious quality defects to the MHRA as soon as possible. Falsified medicinal products are those that deliberately misrepresent their identity, history, or source. Quality defects are those that may affect the safety, quality, or efficacy of the products.
- Cooperate with the MHRA and other competent authorities in case of inspections, audits, or investigations related to their activities. The MHRA has the power to suspend or revoke your registration if you do not comply with the legal requirements or pose a risk to public health.
Quality Requirements
In addition to the legal requirements, a broker should seek training and support from a company qualified to assist them.
Paradigm Shift Consulting is a consultancy that specialises in Good Distribution Practice training and regulatory compliance for brokers and other actors in the pharmaceutical supply chain.
Conclusion
Brokering is challenging activity that requires a high level of knowledge, professionalism and competence.
By following the principles and guidelines of GDP, registering with the MHRA, reporting any issues or incidents, cooperating with the authorities, and adhering to the best practices of their industry, brokers can demonstrate their commitment to excellence and gain trust and recognition in the market.
Brokers must comply with the legal and quality requirements that apply to their activities and ensure that they protect the interests of their customers and public health.
Getting help with GDP Compliance
It is recommended to have an approved and registered consultancy train you and your staff in Good Distribution Practice.
Paradigm Shift Consulting Ltd have a comprehensive team of specialists with extensive experience within their fields who can support you in your compliance needs. If you’re getting started as a new broker, we can assist and advise.
Contact us using the form below to request more information. You can also view more posts with useful data and information on this site’s blog page.
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