Immunotherapy vaccines now need VMD cert

Re: Immunotherapy vaccines now need VMD cert

Graham Bilbrough — Tue, 16 Nov 2010 22:46:00 GMT

Hi, Laurence

There have been many lengthy debates about whether you should attempt to match the source of allergens used in the testing system (in this case coating the wells of an ELISA plate) and the allergens used in the immunotherapy. For several reasons, this would be surprisingly difficult to do:

1. Many reference laboratories have a different supplier of testing "kit" and immunotherapy

2. Despite efforts to obtain pure allergens, there is inevitable variability in biological materials

3. The supply chains for allergens are surprisingly complex and there is a lot of intercompany trading to cope with fluctuations in availability i.e. even if you reference laboratory sources testing and immunotherapy from one supplier, the manufacturer may buy the raw ingredients from many different allergen sellers.

Bottom line: whatever you do, you are unlikely to be able to get an exact match and it doesn't seem to cause a lack of efficacy.

Generally speaking, I have no concerns with taking the results from other laboratories and using them to generate immunotherapy. However, not all systems for serological allergy assessment are built equally--most labs in the UK are doing a great job, but one or two are not. I know from previous posts that you use IDEXX for a lot of your testing--thank you--and I'll give you a ring tomorrow and we can get the testing done again (free-of-charge) if warranted.

All the best

Graham

Re: Immunotherapy vaccines now need VMD cert

Laurence Webb — Tue, 16 Nov 2010 17:55:28 GMT

[quote user="Graham Bilbrough"]

[/quote]

Graham. Is it appropriate to use the results from one laboratory that uses immunotherapy from the USA but order the immunotherapy from a lab that uses the one with an EU MA? I'm not talking about changing a dog that is stable on a US product but to start new cases on. The reason for asking is that we've got results back for a sample that was sent away by a locum who didn't use our normal lab.

Re: Immunotherapy vaccines now need VMD cert

Rob Loxley — Thu, 11 Nov 2010 14:57:04 GMT

[quote user="Louise Alexander"]because of this certificate, which was never needed until now[/quote]

It was always needed, because you are importing a medicine from the USA. We have also found that some labs that didn't previously ask to see the STC are now asking to, and thus prompting the practice that they need the paperwork. Other labs or drug importers have always wanted to see the STC/SIC.

Would be interested if you are PSS or VMD inspected and whether the lack of STCs was flagged up?

[quote user="Louise Alexander"]Is anyone using a provider which manufactures the vaccine in the UK and will therefore not need a VMD certificate?[/quote]

There are none - it's either a free SIC and get from the EU or a fee for the initial STC and get it from the USA. Not sure anyone would suggest moving supplier of vaccine as they may not be exactly the same...

Re: Immunotherapy vaccines now need VMD cert

Graham Bilbrough — Thu, 11 Nov 2010 14:43:21 GMT

If the immunotherapy has Marketing Authorisation (MA) from a country within the EU, then you will require a Special Import Certificate (SIC) from the VMD. If the product does not, then you will need a different type import certificate, confusingly known as a Special Treatment Certificate (STC). An SIC is available free-of-charge and, when obtained on-line, is immediately available. An STC can only be applied for with a paper form (it can be renewed on-line) and costs ~£30. It takes about 10 working days to receive the STC. You should not order immunotherapy until after you have the appropriate certificate (SIC or STC).

Various labs (IDEXX, SENSITEST, others) offer the one immunotherapy with MA from a country within the EU, making the process of getting the certificate far, far easier and less costly for the pet owner. These requirements have been in place for many years and it is work of the responsible MRCVS to make sure the certificate is in place. The cynic might argue that, unless pushed to do so, it may not be in the interest of your laboratory to draw attention to the fact that their product does not have marketing authorisation when an alternative product exits.

All the best

Graham

Re: Immunotherapy vaccines now need VMD cert

Mark Holmes — Thu, 11 Nov 2010 13:55:32 GMT

I have never done a postal one they have all been online and all free!

Re: Immunotherapy vaccines now need VMD cert

Bob Russell — Thu, 11 Nov 2010 13:50:56 GMT

I think the first one has to be applied for by post and is charged at £30 but repeats can be done on-line and are FOC.

Re: Immunotherapy vaccines now need VMD cert

Mark Holmes — Thu, 11 Nov 2010 13:42:07 GMT

It has always been the case I don't know if it has changed but when we request a VMD STC number online there is no charge.