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Updates on OSTENIL® Range Packaging and the Ostenil Approved Clinic Scheme

June 2019
  

Dear Customers and Business Associates,

In this circular we are announcing a few changes to our OSTENIL® and OSTENIL® PLUS packaging and to our “Find an Expert” webpage, and we encourage you to take note of how these changes may affect you.

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 sales 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 these sites that TRB Chemedica UK cannot offer any provenance or quality assurance in relation to the authenticity, quality, safety or efficacy of these products. 
Whilst we are unable to seek verification of product authenticity from these online providers, 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 these websites, asking TRB Chemedica UK 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 in recent weeks we have focused on optimising our transportation and storage standards. Furthermore, as of June 2019, new measures will come into effect to safeguard against counterfeit OSTENIL® range products being sold in the UK. New packaging livery on all genuine 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. The new livery will also be adopted on all OSTENIL® injection packaging in autumn 2019.

Brexit and Supply

Helping to calm the uncertainty around the Brexit issue, TRB Chemedica UK as the manufacturer and sole distributor of the OSTENIL® Range in the UK can, of course, guarantee secure supply arrangements. For more details please also see our “Brexit Contingency Plan” page.

Ostenil Approved Clinic Scheme + Find an Expert Page

In March of this year we sent out a circular explaining the changes to our “Find an Expert” web page, including a form to apply for inclusion in the new “Ostenil Approved Clinic” scheme. Briefly, the page has been renamed “Find an Ostenil Approved Clinic” and now includes search functions by postcode or location, to make it easier for patients to find a clinic in their area that can offer genuine OSTENIL® injections. Approved clinics will shortly receive a unique, numbered certificate from us which they can display in their patient waiting areas. Please note that in order to reassure patients that the treatment they receive is an authentic OSTENIL® product, only clinics who use the new OSTENIL® and OSTENIL® PLUS livery can be included in the scheme.

Please get in touch if you have any questions.

Your team at
TRB Chemedica UK

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