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 fulfillment 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.
The regularity of your bona fides checks for existing customers/suppliers can vary, depending who you talk to.
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;
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.
12 Feb 2019
24 Jan 2019
24 Jan 2019
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