This month, as part of our deep dive series, we wanted to build on our article late last year on the authorisations required to manufacture, import and market medicines.  This time we will look at trading in medicinal products in the UK and EU.  

Trading in pharmaceutical products is a complex regulatory process requiring adherence to stringent compliance standards. From manufacturing and distribution to marketing and post-market surveillance, every step demands meticulous attention to legislation, regulations and guidelines.  While manufacturing or importing medicines requires a Manufacturers and Importers Authorisation (MIA), trading in medicines requires a different licence called a Wholesale Distribution Authorisation (WDA).  This is sometimes still referred to by its old name of Wholesale Dealers Licence in the UK by those of us with one or two grey hairs!

A WDA is a crucial license for businesses involved in distributing medicinal products within the pharmaceutical supply chain. This authorisation ensures that medicines are stored, handled, and distributed in a manner that safeguards public health and complies with legal and regulatory standards. Certain activities are permitted under this authorisation, and similarly, there are some limitations, which we will discuss.

What is a Wholesale Distribution Authorisation and why is it important?

A WDA is a regulatory license issued by the national competent authority of a country, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or National Competent Authorities (NCAs) such as ANSM (France), GIF (Poland), HPRA (Ireland), etc. in the EU. This license allows businesses to engage in the wholesale distribution of medicinal products, including their storage, transportation, and supply to other businesses, such as pharmacies, hospitals, and other wholesalers.

A WDA enables companies to operate in the highly regulated pharmaceutical market while complying with legal requirements.  There are some situations where a sale can proceed, such as the initial sale by an MIA holder; however, in most cases, wholesale distribution of medicinal products without a WDA is illegal. 

The primary aim of the WDA is to ensure that medicinal products are distributed in accordance with Good Distribution Practice (GDP) guidelines, safeguarding their quality, safety, and efficacy throughout the supply chain. By adhering to GDP standards, businesses ensure that medicines remain safe and effective.

Steps to Obtain a WDA

Understand Business Model and Regulatory Requirements:  Each supply chain is unique, and it is an important first step to map out the proposed business model and ensure that a WDA is the correct option and what type of WDA is required (Procure+Supply, Hold, Export, etc.).  Also, each country has its specific requirements for obtaining a WDA. In the UK, for example, the MHRA oversees the application process. At the same time, in the EU, it’s typically handled by National Competent Authorities or, in the cases of Germany and Italy, by local state authorities.  It would be necessary to either research the specific requirements in your jurisdiction, or to engage with a local consultant who thoroughly understands the process in that jurisdiction.

Prepare Your Application:  The application process usually involves submitting detailed documentation about your business, including:

 - The address of the premises where the licence will be held, and where distribution activities will take place.

 - Details of the Responsible Person (RP), who oversees compliance with GDP.  

 - Standard Operating Procedures (SOPs) outlining how you will manage storage, transportation, and quality assurance.

 - In the UK, there will also be a requirement to detail a Licence holder and a Responsible Person for Import or RPi if the wholesaler intends to import medicines from the EU that have already been certified by an EU Qualified Person.

Appoint a Responsible Person (RP):  The RP is a key requirement for obtaining a WDA. This individual must have relevant qualifications and experience to ensure compliance with GDP standards. The RP is responsible for:

 - Overseeing validation, storage and transportation conditions.

 - Managing changes and conducting risk assessments/ investigations.

 - Ensuring staff training on the principles of GDP.

Prepare Your Facilities:  The premises used for wholesale distribution must meet stringent requirements, such as:

 - Adequate storage facilities with temperature and humidity controls.

 - Security measures to prevent theft and unauthorised access.

 - Proper documentation and record-keeping systems.

Undergo Inspection:  Once the application is submitted, the regulatory authority will typically conduct an inspection of your premises and procedures to ensure compliance with GDP.  The Licence holder and RP should promptly address any deficiencies identified during this process in order to gain approval.

Scope and Limitations of a WDA

A WDA allows businesses to store, handle, transport, and distribute medicinal products to authorised entities such as pharmacies, hospitals, and other wholesalers. It ensures compliance with Good Distribution Practice (GDP) standards to maintain product quality and traceability throughout the supply chain.  It is important to note that post-Brexit an EU WDA allows these activities across the EU 27 member states but not in the UK; for that, a separate UK WDA is required.  Similarly, a UK WDA only allows companies to store, handle, transport, and distribute medicinal products in the UK, and once exported to the EU, a separate EU-based WDA is required to trade further in the EU.

While a WDA authorises significant activities within the pharmaceutical supply chain, it does not permit the following:

Manufacturing Medicinal Products:  A WDA does not allow you to manufacture medicinal products. For manufacturing activities, a Manufacturing Authorisation (MIA) is required.

Retail Sale to Consumers:  Wholesale distributors cannot sell directly to consumers. This activity is reserved for licensed pharmacies and healthcare providers.

Distribution of Unlicensed Medicines:  A WDA is typically limited to the distribution of licensed medicinal products. Special authorisation is required for unlicensed medicines or 'specials'.

Deviation from GDP Standards:  Non-compliance with GDP guidelines can result in the suspension or revocation of your WDA.

Handling Controlled Drugs (Without Additional Licenses):  Distributing controlled substances requires additional licenses and adherence to stricter regulations.

Common Challenges in Obtaining and Maintaining a WDA

Complex Regulatory Requirements:  Navigating the detailed requirements for a WDA can be challenging, especially for new businesses. Consulting with experts within your organisation or hiring an external regulatory consultant can help with this.

Cost Implications:  The costs associated with obtaining and maintaining a WDA, including facility upgrades, training, and inspections, can be significant.

Managing Compliance Across Multiple Locations:  If your business operates across several sites, ensuring consistent compliance can be difficult. Implementing centralised QMS and regular training programs can mitigate this risk.

Supply Chain Risks:  External factors, such as supply chain disruptions or transportation issues, can impact compliance. Risk assessments and contingency plans are essential.

Final Thoughts

Obtaining a Wholesale Distribution Authorisation is a critical step for businesses aiming to operate in the pharmaceutical supply chain. While the process involves meeting stringent regulatory requirements and undergoing inspections, the benefits of holding a WDA are significant, enabling businesses to distribute medicinal products legally and safely. By understanding the permitted activities, limitations, and compliance measures, you can ensure that your business thrives while upholding the highest standards of public health and safety.

Whether you are a new entrant to the market or an established player looking to expand your operations, obtaining and maintaining a WDA is not an easy undertaking.  At Orion GXP Consulting, we have assisted many clients over the years in not only obtaining but expanding and maintaining compliance with their wholesale distribution authorisations.

If this service is of interest, we would be happy to assist.  To discuss your needs further, please email admin@oriongxp.com or call +353 7198 10101 (IRL) or +44 203 4750375 (UK)