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 authorisation if they are supplying the end user in quantities of less than 3 months supply. Brokers required a broker registration, which permits negotiation on trades, but not the ability to buy, sell or hold.
The WDA (H) covers both licensed and unlicensed medicines, as well as investigational medicinal products (IMPs) for use in clinical trials.
A wholesale distribution authorisation WDA-h is a legal requirement for any company that stores or distributes human or veterinary medicines in the UK. The WDA (H) is issued by the Medicines and Healthcare products Regulatory Agency (MHRA), which is the UK 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 dealer 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.
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, and a WDA (IMP) is for investigational medicinal products.
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.
To apply for a WDA (H), one needs to complete an online application form on the 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, one needs to demonstrate 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.
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:
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.
If you need help, we can offer a free over-the-phone initial consultation on 0330 133 0920 or you can email us on info@ukgdpassociation.co.uk. Alternatively, use the contact form at the top right of this screen.
Below are a selection of posts associated to this topic.
Inspections And First Party Audits
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What are GDP Guidelines for Medicinal products?
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