Dear Valued Customer / Business Associate,
It has been brought to our attention by a number of concerned customers, that certain wholesalers or their agents have been making unsolicited approaches offering to sell OSTENIL® range products at discounted prices. This type of practice has persisted for many years, but it is incumbent on TRBUK as both the UK subsidiary of the manufacturer, and sole manufacturer-approved seller of OSTENIL® in the UK, to reiterate the potential problems associated with purchasing and re-selling non-UK liveried, unapproved supply chain OSTENIL® products.
CE Mark and Online Providers
For too long CE-marked devices have found their way into the UK market when they may not even have verified CE status. TRB Chemedica (UK) Ltd is aware of a number of internet-based and physical wholesaler companies offering TRB Chemedica proprietary products (primarily OSTENIL® and OSTENIL® PLUS) at heavily discounted prices. We must advise customers purchasing any of the OSTENIL® products from any source other than TRBUK or their registered wholesalers/suppliers, that TRB Chemedica (UK) Ltd cannot offer any provenance or quality assurance in relation to the authenticity, quality, safety or efficacy of these products.
Whilst we are often unable to seek verification of product authenticity from third-party re-sellers, as we have no legal jurisdiction to compel them to reveal their supplier’s details, we receive many enquiries every year from people who have purchased from non-approved sources, asking TRBUK to verify their products. Unfortunately, we cannot attest to the accuracy regarding the batch numbers, use by date, manufacturing integrity, storage, or transportation conditions of any TRB Chemedica products purchased from a non-accredited third-party re-seller, nor can we accept any liability arising from their use within the UK.
Pack Identifiability
At TRB Chemedica UK we continuously review our stringent safety procedures, and we are focused on optimising the integrity of our transportation and storage standards. As of June 2019, new measures came into effect to safeguard against counterfeit OSTENIL® range products being sold in the UK. New packaging livery on all genuine Ostenil and OSTENIL® PLUS injections, featuring the UK flag for easy pack identifiability, will ensure our customers purchase only verified and quality assured products. In addition, the English-only pack insert with “Instructions for Use” or SPC, reduces the possibility of counterfeit suppliers “passing off” their wares – which usually include multi-language instruction sheets - as genuine.
Brexit, CE mark and UKCA Mark - Supply Chain Changes
Now that the changes from the Medical Device Directive (MDD) to Medical Device Regulations (MDR) have been effected in the EU and UK, all genuine OSTENIL® intra-articular products are now compliant, and the MDR certification applies to all TRB Chemedica intra-articular injections. As of July 1st, 2023, [UPDATE: This has now been delayed until 2024] only genuine OSTENIL® range products delivered via closed logistic supply chain from our manufacturing plant to TRBUK will carry the UKCA mark, and this will render any Ostenil range products purchased from any other source illegitimate. TRB Chemedica UK as the manufacturer and sole approved distributor of the OSTENIL® Range in the UK can, of course, guarantee secure supply arrangements, and we will exchange any products purchased from us that go out of date on the shelf free of charge upon receipt of the out-of-date unit/s. In addition, by entering into a Supplier Agreement with TRBUK, customers can take advantage of the generous discounts available.
For more details, please contact info@trbchemedica.co.uk.
Please get in touch if you have any questions.
Yours sincerely,
TRB Chemedica UK