Cannabis Based Medicinal Products – CBPMs

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Since the approval for specialist prescribers to write scripts for CBPMs (Cannabis based medicinal products) was given for 01 Nov 2019, there has been a flurry of activity to get licensed.

Paradigm Shift have had multiple enquiries about licensing for the procurement and supply of CBPMs, and are working with a number of companies in their applications for WDA (Wholesale Distribution Authorisation), Home Office narcotic licence and in some cases their MS (manufacturer specials licence).

There have been many questions raised by prospective and existing clients, including pharmacies. The NPA have posted a Q and A on their website on the selling / supplying of cannabis based medicinal products and CBD containing products.

It’s true that the legislative and regulatory minefield is perplexing many, not least dealing with the MHRA and Home Office teams, and applications for licences.

Interested in becoming licensed for procurement and supply of CBPM?

Contact us with information on your;

1) Business model – what do you wish to achieve, and what is your route to patient. If you have need of assistance we can support with the infrastructure, however we do not provide customers ;
2) Your Company structure: An organisation chart, staff and proposed chart for when you grow, including details of your team (job descriptions, responsibilities, deputies/interrelationships);
3) Experience: What knowledge do you with wholesale and controlled drugs and business in general?;
4) And… Anything else that may help us support an application.

As with all WDA or Home Office drug licences organisations that apply are expected to have a soundly defined business model.

You must have a robust quality management system, defined and qualified suppliers and customers, a sufficient number of competent personnel with training and job descriptions, approved third parties for any outsourced activities (including us), suitable and sufficient premises, risk assessments, route and lane validations for distribution, an approved and audited storage and distribution site, temperature mapped and qualified delivery vehicles and a senior management team who will be leading the business with a quality focus and have evidence of their active participation.

Errors/deviations should be appropriately documented and corrective actions put in place.

If you don’t have the knowledge or structure, we can help build it, but only if you embrace quality risk management principles and take the appropriate training and advice.

Paying lip service will ultimately end in a poor inspection and potential suspension of your ability to trade.

We offer regular training at our Rushden offices, and recommend anyone thinking about getting a WDA attends to see what it really involves.

Interested in growing cannabis products? This is also a licensed activity.

More information can be found HERE

Want to know more, or to set up a CBPM wholesale operation?

Contact us at info@paradigmshiftconsulting.co.uk to arrange a no obligation consultation, and we will advise you on your best route.

Please note that the best route may be to reconsider.

We have had a good number of enquiries that were ill-advised and had “no legs.” In these cases our advice is to go and think it over.

In relation to whether this is a good investment, it’s still too early to tell.

The “party” has not yet started, and if you invest now you may have opportunities later… or you may be better off saving your money and looking to purchase a business later.

Either way if you wish to go into business supplying CBPM then you need to understand the expectations of the competent authority and be able to deliver them.

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