What is a WDA (H) (Wholesale Distribution Authorisation)?

WDA (H) Explained

Being in possession of a Wholesale Dealers  Authorisation WDA,  is a legal requirement for any company that procures, stores or distributes human or veterinary medicines in the UK. , which is the UK Competent Authority responsible for ensuring the quality, safety, and efficacy of medicines.

The WDA (H) is also known as a “wholesale dealer licence” or a “wholesale distribution authorisation”, and it replaces the previous term of Wholesale Dealers Licence (often called WDL or WL).

A little known fact is that the WDL was the licence permitting supply of GSL medicines, whilst WL was a full wholesale licence.

The purpose of the requirement to hold a WDA (H) is to ensure that the regulations and guidelines relating to the procurement, supply, holding and export of medicinal products are upheld, and that the quality and integrity of the medicines are maintained throughout the supply chain, from the manufacturer to the end user. It also seeks to prevent the introduction of falsified, counterfeit, substandard, or unauthorised products into the market, which could pose a serious threat to public health.

Who Needs a WDA (H)?

Anyone who procures, stores, or supplies medicines to anyone other than the patient using the medicine needs a WDA (H). This includes wholesalers, distributors, importers and exporters.

Online retailers of medicines do not require a wholesale dealers authorisation if they are supplying the end user in quantities of less than 3 months supply. Brokers require a broker registration, which permits negotiation on trades, but not the ability to buy, sell or hold.

There are different types of WDA available depending on the nature and scope of the distribution activities. For example, a WDA (H) is for medicines for human use, and a WDA (V) is for medicines for veterinary use.

WDAs will vary as to the specific conditions or restrictions attached to them, such as the type of products, the licence status of products (e.g. Licensed or Unlicensed), the source of products, or the destination of products.

There are different types of WDA available depending on the nature and scope of the distribution activities. For example, a WDA (H) is for medicines for human use, a WDA (V) is for medicines for veterinary use.

WDAs will vary as to the specific conditions or restrictions attached to them, such as the type of products, the source of products, or the destination of products.

How to Apply for a Licence

To apply for a WDA (H),  you will need to complete an online application form via the MHRA   PCL Portal
(www.pclportal.mhra.gov.uk) and submit it to the MHRA, along with the required accompanying documents and fees.

The application process is listed as being 90 days from submission (and you must be ready and sign a declaration stating so), however during times of high activity this can be elongated to 90 working days.

To be successful in your WDA (H) application,  you will need to be able to  demonstrate full compliance with the Human Medicines Regulations (2012), GDP principles and guidelines which cover the quality system, personnel, premises and equipment, documentation, operations, complaints, recalls, returns, falsified medicines, outsourced activities, self-inspections, transportation, and brokers.

These requirements are addressed in the 10 Chapters of the EU GDP Guidelines (2013/C 343/01).

The MHRA will conduct a GDP inspection of the site before granting or renewing a licence and will also conduct periodic risk-based inspections to monitor ongoing compliance.

What are the Responsibilities of the Licence Holder?

The WDA (H) holder has a number of responsibilities and obligations to ensure the compliance with the GDP standards and the WDA conditions. Some of these include:

• Implementing and maintaining a quality system that meets the GDP requirements
• Appointing a responsible person (RP) for GDP, who oversees and ensures the compliance with the GDP principles and guidelines
• Ensuring that the personnel involved in the distribution activities are adequately trained and competent
• Verifying the authenticity and quality of the products before they are procured, stored, or supplied
• Managing the risks associated with the distribution activities, such as deviations, complaints, recalls, and falsified medicines
• Conducting self-inspections and audits of the suppliers and customers
• Keeping accurate and up-to-date records of all the distribution activities
• Cooperating with the MHRA and providing them with the necessary information and documentation
• Reporting any suspected adverse reactions or quality defects to the MHRA
• Notifying the MHRA of any changes to the WDA (H) details or activities
• Renewing the licence every five years

Conclusion

Applying for a WDA (H) is a lengthy process which has to be undertaken with care and attention to detail.

It cannot be rushed and all your facilities, systems and procedures must be in place prior to submitting your application. This includes the GDP training of your staff.

Paradigm Shift Consulting Ltd are specialists in assisting start-up businesses in acquiring their first WDA licence, supporting wholesalers and manufactures in supported self-inspections, training and contract Responsible Person and QA services, and specialise in the prevention of suspension, and supporting companies out of suspension and a consequential (and hopefully temporary) loss of their WDA licence.

Call us for more information if you need advice, or  contact us via our GDP and Wholesale Questionnaire and we will get back to you.