Pharmaceutical and biotechnology companies are required to comply with strict regulations to ensure medicines are safe and effective. One key requirement for wholesaling activities is the Wholesale Distribution Authorisation (WDA). In the EU and UK, all wholesale distributors of medicinal products must possess an authorisation to engage in wholesaling activities related to medicinal products, safeguarding their quality, safety, and efficacy throughout the supply chain.
A WDA is required for any company that is involved in procuring, supplying, storing (storing medicinal products for over 72 hours), handling and distributing medicinal products within the EU or UK. This authorisation is a legal certification issued by national competent authorities to entities involved in the wholesale distribution of medicinal products. In the EU, the regulatory authority is the European Medicines Agency (EMA) and, in the UK, the regulatory authority is the Medicines and Healthcare products Regulatory Agency (MHRA).
This licence ensures that companies meet specific standards for procuring, supplying, storing, handling and exporting medicinal products to ensure quality and safety of the products is maintained throughout the supply chain. Companies without this licence are prohibited from legally distributing medicinal products to hospitals, pharmacies or other entities.
Furthermore, a WDA indicates that an organisation operates in compliance with Good Distribution Practice (GDP) guidelines (see 2013/C 343/01 Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use). GDP assures that the medicinal products delivered to the end-user are safe, effective and high quality. By regulating this process, regulatory authorities aim to minimise risks related to product tampering, diversion, mishandling, contamination and the possible entry of falsified medicines into supply chains. Every WDA that is issued is legally required to have a named Responsible Person (RP) who is responsible for ensuring the conditions of the WDA are met.
Who is required to have a WDA?
Each medicinal product supply chain is unique and it is important to firstly map out the proposed business model to determine if a WDA is needed and what type of WDA is needed. Any entity who procures, holds, supplies or exports medicines to anyone other than the patient using the medicine needs a WDA:
- Procurement (purchase) of medicines for human use.
- Holding (storage) of medicinal products for human use.
- Supply (sale within the EEA) of medicinal products for human use, apart from to the public.
- Export (sale to outside the EEA) of medicinal products for human use, apart from to the public.
Without a WDA, these entities risk penalties, operational disruptions and reputational damage. Understanding whether your business operations fall under its scope is crucial to avoiding non-compliance.
Brokering of medicines is different to wholesaling, as it does not involve owning or physically handling medicines. It involves:
- Negotiation for procurement (purchase) or supply (sale) of medicines.
- Acting independently and on behalf of another legal or natural person.
Organisations that do not store medicines for more than 72 hours do not need a WDA. Furthermore, organisations that solely transport medicines do not need a WDA but are required to comply with GDP as it per pertains to transportation.
Require support with obtaining a WDA?
Navigating the requirements for obtaining a WDA can be difficult without the support of an experienced partner that is familiar with the regulatory requirements. HiTech Health has a team of Responsible Personnel (RPs) and Qualified Personnel (QPs) who are deeply experienced with working with a diverse range of life science companies to obtain a WDA. In addition to this, we provide contract RP services that allow our team to fulfil the role of RP on your behalf. This cost-effective solution includes end-to-end support from regulatory inspection through to oversight of wholesaling activities. Our team have led regulatory inspections on behalf of clients, delivering post-inspection support to address any inspection findings.
Contact our team today and schedule a call to find out how we can support your WDA application.