Are your suppliers and customers validated or bona fide?
Bona fides checks are a critical piece of the GDP puzzle. Within the EU Guidance 2013/C 343/01 the term “bona fide” is not used, however this is a common turn of phrase in the industry.
One of the twelve key duties of the Responsible Person is to ensure that “suppliers and customers are approved” (Chapter 2 – Personnel. 2.2 (vi) ensuring that suppliers and customers are approved).
Approval of suppliers and customers is also listed in Chapter 5, operations.
CHAPTER 5 — OPERATIONS 5.2. Qualification of suppliers Wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question (article 80(b) of Directive 2001/83/EC).
Wholesale distributors receiving medicinal products from third countries for the purpose of importation, i.e. for the purpose of placing these products on the EU market, must hold a manufacturing authorisation (article 40(3) of Directive 2001/83/EC)
Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor, must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10 (1). Appropriate qualification and approval of suppliers, should be performed prior to any procurement of medicinal products. This should be controlled by a procedure and the results documented and periodically rechecked.
When entering into a new contract with new suppliers, the wholesale distributor should carry out ‘due diligence’ checks in order to assess the suitability, competence and reliability of the other party.
Attention should be paid to:
(i) the reputation or reliability of the supplier;
(ii) offers of medicinal products more likely to be falsified;
(iii) large offers of medicinal products which are generally only available in limited quantities; and
(iv) out-of-range prices.
N.B: These are no longer exhaustive examples of where falsified products may be supplied. It is often the case that one or a few samples of genuine product are supplied, with falsified goods following. It may be that prices offered are not considered out-of-range i.e. a few percent less.
5.3. Qualification of customers
Wholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public.
Checks and periodic rechecks may include: requesting copies of customer’s authorisations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation. Wholesale distributors should monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Steps should be taken to ensure fulfilment of any public service obligation imposed upon them.
So… what does this mean to you? In plain English?
Before commencing any trade activities you should ensure that;
You obtain a full copy of the potential customers/supplier WDA(H) aka Wholesale Distribution Authorisation for Medicines Human Use. Sign, date and print your name to show when you reviewed the documents. A basic copy of the licence is not helpful, nor does it show you reviewed it.
These licences can be viewed on the MHRA list of WDAs. This list also includes the sites named on the licence and the types of product each site can handle.
Special attention should be paid to the product classes listed, to reduce the risk of handling products that you are not licensed to be handling or supplying.
Consider sending a “GDP Questionnaire” for completion, or a new customer/supplier form containing similar requests for information.
A copy of the company’s GDP Compliance certificate should be requested, but in the case of a site that has not yet been inspected since the 2013 update to GDP their post inspection close out letter is a viable alternative (N.B. This is NOT your letter containing deficiencies, but the letter confirming that your site has been inspected and that all deficiencies have been closed out). Search for this GDP Certificate via Eudra GMDP if you are able. This is more important for suppliers than customers, but we like to check. Ensure that there are no sanctions or comments on the GDP Compliance cert that concern you.
When reviewing the GDP Compliance certificate ensure that the date on it is valid! Also the length of time listed. Five years indicates a site that is controlled. Two years may indicate a newly licensed site due for re-inspection within a year OR deeper compliance issues.
Note: This is not always consistent, we have viewed some sites that have a five year GDP Compliance Certificate, but are due a re-inspection as a new site.
Remember that pharmacies CANNOT supply product, without a WDA. An “insignificant amount” may be traded at NO PROFIT only. This might constitute a few packs over a year, no more.
Wherever possible the company is a known entity and has a good reputation. This is not always realistic, but part of your bona fides due diligence could be that you check companies house when setting up an account, as well as the other checks listed above.
The regularity of your bona fides checks for existing customers/suppliers can vary, depending who you talk to.
Paradigm Shift recommends that full bona fides checks are carried out at LEAST annually, but more frequently if feasible, and especially on a risk basis… If you decide to keep trading with a company that has been suspended, you may want to audit them or carry out more frequent checks… or cease trade. Sites overseas or 100 hour pharmacies may require more frequent, quarterly, checks.
Checks on the MHRA website for suspended or revoked licences should be carried out at LEAST once per month, but the MHRA recommend every fortnight in the Green Guide. Recently the MHRA have started sending emails when the lists are updated.
The list of Terminated and Cancelled licences should also be checked twice a month, as there is always the risk that someone is using an old WDA “borrowed” from someone else.
Where you supply a pharmacy or surgery (or dentist or midwife etc.) make sure that you check the professional body website quarterly, or at least three times per year.
You should also be carrying out due diligence on any customers or suppliers.
How do I do that, I hear you ask?
A few suggestions are;
– Are they listed as an active business on companies house?
– Are they registered for VAT?
– Are they known to you or others in your network… in a positive way?
– Can you get references, and DID YOU CHECK THEM? Check, sign and date.
– Are they offering hard to source lines at out of range prices? Even 5 Sutent may be an odd quantity now it’s become a “hospital” line.
– What other evidence of their ID do you have? Do you have a redacted utility bill, or a copy of their bank details? The money trail is one of the key things to track.
– Check the www.who.is website and see how old their website is. Companies claiming to be “one of the largest distributors in <country>” who are less than 3 months old may be telling you stories.
– Are they supplying you with a product you’ve never bought before?
– What shows up on google searches? Is there anything negative when you type in their company name?
This list is not exhaustive! Be inquisitive, because if you aren’t there may be a bigger price to pay.
Still need help? Call us for a free five minute consultation and wherever possible we help you for free!
Want it straight from the horses (or regulators) mouth?
See these excellent blog posts by Tony Orme, Senior Inspector of the MHRA.
We still recommend the regular exchange of paperwork, as it is a chance for contact.
Where possible make a call and make personal contact, rather than email requests.
Remember suppliers are as important as customers, and that to have good supply you need to have a good relationship with the right supplier.
10 Mar 2020
2 Apr 2019
2 Apr 2019
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