Approval was given in 01 November 2018 for specialist providers to write scripts for Cannabis-Based Products for Medicinal Use (CBPM).
Since then, there has been a lot of activity to get licenced. The Paradigm Shift Consulting office has received a number of enquires about licensing for procurement and supply of CBPMs, and we are subsequently working with companies to assist them with applications for Whole Distribution Authorisations, Home Office narcotic licences and MS (Manufacturer Specials licence). Growing cannabis is also a licensed activity.
Dealing with CBPM: What’s involved?
If you are interested in getting involved with CBPMs there are a number of things you will need to have:
- A strong quality management system
- Qualified, legitimate customers and suppliers
- Competent personnel that have suitable training and defined job descriptions
- Approved third-parties for outsourced activities
- Risk assessments
- Route and lane validations for distribution
- A storage and distribution site that has been audited and approved
- Vehicles that have been temperature mapped and qualified
- A senior management team who actively partcipate (with evidence) with quality focus
- Documented errors/deviations with corrective actions in place
If you don’t have the correct structure we can help you to build it, but only if you are willing to embrace quality risk management (QMS) and take the appropriate training and advice.
Setting up a CBPM wholesale operation / Becoming licensed for procurement and supply of CBPM?
At first, it can seem exciting and a great opportunity for both business and patients alike. However it is not straight-forward.
There are important things to be done and put in place before it becomes your reality. When you contact us, you must expect to be asked for the following:
1) Your business model: What do you wish to achieve, and what is your route to the patient. If you need assistance, we can support with your infrastructure. However we do not provide you with customers, nor do we supply any kind of database (phone numbers etc) to that effect.
2) Your company structure: An organisation chart, your staff and proposed chart for when you grow, including details of your team (job descriptions, responsibilities, deputies/interrelationships), management structure.
3) Experience: What knowledge do you have of wholesale, controlled drugs and business in general?
4) And… Anything else that may help us support an application. This may include photographic evidence of your premises, and evidence of your company’s fiscal health: Do you have the sufficient funds to finance this undertaking? (this is a serious question as some who have approached us have transpired to have insufficient funding and have had to abandon their application at considerable cost).
Expect: A physical audit from us at any point of the proceedings.
However, the best option may be to reconsider…
We have had enquiries from companies that have been ill-advised and did not turn out to be suited to this route. We advised in all cases to go back and think it over. You may be better off saving your money and looking into this later when there is more information to go on.
Getting set up and licensed for CBPMs is an expensive business and cannot be walked into with rose-tinted spectacles. Paradigm Shift Consulting Ltd will never lead your company down a path it cannot afford or is hopelessly ill equipped for and take your money regardless, even when failure is certain. That is not how we work.
We have a range of courses available to help you and your staff achieve a robust GDP in your company. If you know or suspect that your GDP is not up to scratch, or if you are considering getting involved in the procurement, storage, transportation and distribution of CBPMs, then call us. We have specialist consultants in this and all related areas of expertise. Alternatively, use the contact form below. Do take a moment to browse our courses using the below button link.
CONTACT FORM
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