For those who do not already know, the “5% rule” for pharmacies disappeared some time ago and to purchase products from a site without a WDA (Wholesale Distribution Authorisation) is a critical deficiency in Good Distribution Practice.
Prior to 14 August 2012, section 10(7) of the Medicines Act 1968 provided a pharmacist in a registered pharmacy (or someone acting under their supervision in that pharmacy) who sells, supplies or offers sale or supply of a medicinal product by way of wholesaler dealing, with an exemption from the requirement to hold a WDA.
This exemption allowed up to 5% of the total turnover to be traded.
This was repealed under the Human Medicines Regulations 2012 (S.I. 2012/1916), which were laid on 24 July 2012 and came into force on 14 August 2012. The exemption was outside the European Directive 2001/83/EC (6 November 2001) on medicines for human use within the community.
This means that any wholesale supply of stock medicines on a commercial basis by a pharmacy now requires a WDA(H).
The MHRA has published guidance on this issue. This recognises the valuable work that pharmacies (both hospital and community) provide within their local health economies in respect of supplying medicines to others who need to hold them to pass on to their patients.
By way of an example, the MHRA guidance provides that pharmacists in a pharmacy needing to obtain small quantities of a medicine from another pharmacy to meet a patient’s individual needs may do so without the need for the supplying pharmacy to hold a WDA(H). However, the transaction must meet all of the following criteria:
– It takes place on an occasional basis;
– The quantity of medicines supplied is small and the intention is to meet the needs of an individual patient; and the supply is made on a not for profit basis.
This is to prevent abuse of the regulations and to ensure that the supply chain and integrity of the product is maintained.
It is still possible for a pharmacy to supply a small amount of medicine to a nearby pharmacy, possibly for emergency supply, but not for profit. Realistically this would be a few packs every few months. More than that is likely to draw negative attention.
To be able to buy from a pharmacy that site must hold a WDA otherwise you are at risk of licence suspension for buying from an unlicensed site.
If you do (or wish to) supply to dentists, other pharmacies, GP surgeries/clinics, hospitals or wholesalers you MUST have a WDA.
Need help, or some advice on whether you need a WDA?
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