With the “New” GDP guidelines now having been in effect since September 2013, and the requirement for registration of brokers of pharmaceutical products the Paradigm team are quite surprised at how few brokers are registered.
AT last check (4th Feb 2015) count there are only seventeen/17 pharmaceutical brokers registered, whether as companies or individuals.
Why so few, I hear you ask, and this is the question that many are asking.
In our opinions many brokers have gone “underground” by attaching themselves to a wholesaler, or wholesaling pharmacy, and getting themselves a job title, business card and email, to work on a commission basis, but effectively broking.
Is this really the case? We honestly don’t know and can only speculate on this, but with around two and a half thousand/2500 wholesale distribution authorisations, with five thousand/5000 sites in the UK it seems a very low number.
Many broker unknowingly. Introduce people by all means, but start negotiating and working between others in a commercial capacity in any way (I’ll buy you a drink… here’re a few quid… Christmas is coming) and you are liable to be judged as a broker. An unlicensed broker.
So what is a “broker” or “broker of pharmaceutical products?”
The definition of a broker from the EU GDP Guidance of November 2013 is;
A ‘broker’ is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.
What does this mean?
The term “middle man” could be used (or should that be middle person?!), but like any “commodity” (and I apologise for the use of that term) medicines are a traded item.
Whether it’s cotton, coffee, frozen orange juice, pork bellies or pharmaceuticals, there is a market.
So… a broker is not a wholesaler. They don’t physically handle the goods, but negotiate.
There is a requirement for a quality management system, although an abridged one compared to wholesale distribution sites.
So, what needs to be in place if you want to be a pharmaceutical broker in the EU?
1) A procedure for management and handling of complaints
2) A procedure for advising the CA (Competent authority) and MA (Marketing authorisation) holders of suspected falsified/counterfeit products
3) A procedure for recalls
4) A procedure to ensure that any brokered products have an MA
5) A procedure for verifying that suppliers have a WDA (Wholesale Distribution Authorisation) or MA, and that customers are authrosied to supply medication in their particular member state (bona fides checks)
6) Records of transactions of products brokered, containing date, name of the medicinal product, and the quantity brokered; name and address of supplier and customer; and the batch number of any product with safety features, but ideally any products traded.
Also, you need contacts. Suppliers, and customers. The more reputable and well know, the better.
We have assisted one of the 17 UK pharmaceutical brokers attain a licence and will help approve one more shortly, however is the cost worth it?
Some will definitely say yes, as they commit resource and expertise to their pharmaceutical wholesale business, and get great results by giving high levels of service for reasonable returns. Others say “wholesaling is done…” but in our experience these are the easy-riders and get-rich-quick crowd.
In any business you should aim for excellence. We are considering ISO:9001 accreditation to give some comfort to our corporate customers, and value to our services. Remember that a good pharmaceutical wholesaler or pharmaceutical brokers licence is close to being ISO standard, and if your operation is slapdash, staffed with untrained and demoralised personnel you are a risk to human health.
Want to negotiate independently and on behalf of another legal or natural person, with pharmaceutical products?
We can help, and consider practical, compliant solutions that fit your business model or needs. There are many ways to be compliant and ensure product quality.
Call for a free five minute consultation… or send a message via our contact page.
Consultancy need not be a dirty word.
Welcome to a new Paradigm!
13 Mar 2017
24 Feb 2017