How to be a Broker in Good Distribution Practice

If you are interested in becoming a 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.

Legal Requirements for a Broker

Brokers are subject to 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. The registration process involves providing information about the broker’s identity, contact details, scope of activities, and quality system. The MHRA maintains a public list of registered brokers on its website.

Comply with the principles and guidelines of Good Distribution Practice (GDP) , which ensure that the quality and integrity of medicinal products are maintained throughout the supply chain. GDP covers aspects such as personnel, premises, equipment, documentation, subcontracting, complaints, recalls, transportation, and risk management.

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, composition, 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, brokers should also follow the quality standards and best practices recommended by professional bodies and industry associations.

One such example is the British Association of European Pharmaceutical Distributors (BAEPD) , which represents brokers and parallel distributors in the UK. The BAEPD has developed a Code of Practice that sets out the expectations and responsibilities of its members in relation to GDP, ethics, transparency, and customer service.

Another example is a consultancy firm that specialises in GDP training and compliance for brokers and other actors in the pharmaceutical supply chain. They must also be registered, UK based and able to advise you in whatever area you need help with. Most of all, they must be fully versed in the current regulations (5 year old regulations are no good) in both the HMR 2012 and the EU GDP Guidelines (2013/C 343/01).

Conclusion

Brokering is a challenging but rewarding activity that requires a high level of 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.

A Broker must comply with the legal and quality requirements that apply to their activities and ensure that they protect the interests of their customers and the 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.

We 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 by calling 0330 133 0920, or email us on info@ukgdpassociation.co.uk.

You can also view more posts with useful data and information on this blog page.

Below is a selection:

EU GDP Guidelines (2013/C 343/01) Chapter 10

Human Medicine Regulations (2012) Chapter 3 Pt.45

Gov.uk

British Association of European Pharmaceutical Distributors

Why Good Distribution Practices Matter for Pharmaceutical Products

What Is A Wholesale Distribution Authorisation?

the Legal Supply Chain: Protecting The Patients