Anyone in the UK who acquires, stores or supplies medicinal products (including exports) must apply for an authorisation from the MHRA. Depending on what they intend to distribute – Human or Veterinary – two kinds of authorisation are available. Companies or individuals that plan to wholesale deal medicinal products across the EU must obtain a WDA(H).
Medicinal products which are medicines for human use are subject to the provisions of the Human Medicines Regulations 2012. This includes unlicensed medicinal products commonly referred to as “specials”.
The Human Medicines Regulations 2012 defines wholesale distribution of medicinal products as: “selling or supplying it, or procuring or holding it or exporting it for the purposes of sale or supply to a person who receives it for a purpose. Those purposes are selling or supplying the product or administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.”
It is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the UK through to supply to the public, so as to guarantee that such products are stored, transported and handled in suitable conditions. The requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products
The holder of a Wholesale Dealer’s Licence must fulfil certain obligations and conditions
Persons operating from the UK require a Wholesale Dealer’s Licence, if in the course of their business, they are engaged in:
EOMI Consultancy has been helping UK Medicinal Wholesale Distributors to comply with the current guidelines. We provide a comprehensive ‘one stop shop’ consultancy, assisting companies in applying for authorisations or variations to existing authorisations. When obtaining a Wholesale Distribution Authorisation (including pharmacies) to cover the category of medicines they wish to distribute, applicants must ensure that suitable secure premises are available and suitable SOPs complying with Good Distribution Practice (GDP) guidelines have been developed. Our consultancy will advise on premise requirements and help customers to prepare a set of effective SOPs. Additionally, our Senior Consultant is available for assistance during the MHRA Pre-licensing Inspection.
GDP Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) stipulate the requirement of the Responsible Person (RP) as well as their duties and obligations expected of them by undertaking this role. The RP must have a high level of knowledge, demonstrate competence and deploy the right skills so that patients and healthcare professionals have the confidence and trust to use medicines.
Empowering pharmaceutical distributors worldwide to uphold impeccable standards of Good Distribution Practice (GDP), ensuring the safe and reliable delivery of medicinal products to those in need.
Our mission is to partner with GDP customers, providing tailored consultancy services that foster compliance, efficiency, and excellence in pharmaceutical distribution. Through expert guidance and unwavering support, we aim to safeguard public health and instill confidence in the integrity of the pharmaceutical supply chain.
In the intricate dance of pharmaceutical distribution, our consultancy serves as the guiding light, ensuring each step is taken with precision and care.
info@eomisconsultancy.co.uk
01933712313
138 Fitzhugh Rise, Wellingborough, Northamptonshire, NN8 6BU
