Big Changes Ahead in the UK

[B.Scott]

I was just reading a post on Koi-Quest and it seems that the UK (and possibly the rest of Europe?) is heading for a drastic change in the laws governing the sale and distribution of Koi medications and treatments.

The Veterinary Medicines Directorateare are on the brink of outlawing most medications and all anaesthetic used to treat koi at the moment. The only remaining treatments will be the prepackaged, over priced, stuff sold by firms like Tetra that are basically worthless to the koi hobby

Take a wade through the new regs and decide if it might not be in our best interest to make a lot of noise on this matter?

http://www.vmd.gov.uk/Industry/SAES/saes.htm

Read the thread on Koi quest as well if you wish.
http://www.koiquest.co.uk/forum/viewtopic.php?t=1268

B.Scott

[bekko]

Brian Scott,

I do not understand it all, but would like to. Aren't the only products affected things like nitrofurazone and streptomycin, which are popular in the aquarium hobby, but are not used on koi? To tell you the truth, I do not like antibiotics hanging on the shelf at the local pet store anyway. The injectables are not legal for over-the-counter now, and would not be legal under the new scheme.

Am I missing something?

-steveh opk ins

[marco]

Hi , nice thread for a really big problem which is really in the actuallity.

Normaly the delivery of antibiotics for animals should be delivered only with a vet prescription and sold by somebody who is allowed to sell drugs (chemist, vet ). If some petshop has to sell drugs, they should have a vet covering the responsability, normally the big one have a salaried vet.
When the vet make a prescription, he should indicate the complete identification of the animal so that confusion is impossible (ex Male Girin kushibeni sadan kohaku or electronic identification for company animals), the name of the owner and the way of using it.

You can imagine that the low is so difficult to follow that it's quiete impossible to respect it for all animal, so why ,until now, it was accepted that some people were selling some stuff that they weren't allowed to sell.
Actually in europe, governements try to put some order and make a lot of control by shops, chemist, vet and when they find some irregularity they give some tax penality.

I know a vet in North of France who had a control in his office for all the prescription he made for one year and they found 150 small irregularity so he has been condamed to pay 250.000 €uros !!!!!! Of course he doesn't accept his bankrupt, so he's going in court but we don't know what will be deceided.
The low is also more complicated for vet working with big animals so that a few one have deceided to stop their big animals activity and only work with small one.
In fact all begin to be really complicate for everybody.
I don't know how things will go on, but the time when it was easy to find antibiotics and other drugs is over.
Marco

[gaetano]

I understand there are a lot of problems with the level of antibiotics used in animals bred for consumption, but they should really allow people to treat their pets adequately!

[marco]

Hi Gaetano I agree with you, but the main problem is as soon you have acces to such drugs (anesthesic, antiobio ...), you could use them also for animals that will be eaten by others. Why couldn't you use it for sheep or cow ..
Most of antibiotic used for koï (Nuflor, Baytril, amycacine ..) are mainly used for big animals. So the pressure of the consumer about safety of the food is so strong that public powers must do something to reassure them and to keep the consumption of meat and animals products.
Marco

[B.Scott]

Thanks for the extra input Marco

Bekko this whole issue is VERY complex and involves a great deal of in depth reading and cross referencing to get the whole picture.
As far as I can tell what it basically boils down to is that in the UK and the entire EU soon to follow, drastic restrictions are about to be placed on the manufacturer, distribution, import and sale of most medicines used to treat our fish.


Small Animal Exemption Scheme
Species included within the scheme

• aquarium fish, (meaning fish kept in closed water systems)
• cage birds (meaning birds kept in cages or aviaries),
• homing pigeons (meaning pigeons kept for racing or exhibition),
• terrarium animals (meaning reptiles, amphibians and arthropods kept in tanks and cages and including animals free-living in domestic gardens),
• small rodents (meaning domestic mammals of the order rodentia),
• ferrets,
• rabbits.

The exemption applies only to pet animals not intended for human consumption.

Even though a few medications for non-consumption fish will be exempt, medicines that are still approved will subject to new (read expensive) safety and control regimes placing the manufacturing capacity outside the capability of smaller koi-specific suppliers like Kasuri etc. All producers must still meet the same stringent norms and controls relating to the manufacture of any veterinary medicine.

Requirements for manufacturers and distributors
Although products covered by this Scheme are exempted from the requirement to hold a marketing authorisation, they are still legally classed as veterinary medicines. They must therefore meet all the requirements of the Veterinary Medicines Regulations 2005 relating to the manufacture and wholesale dealing of veterinary medicines.


Some meds will be available simply as a generic product e.g Potassium Permanganate would be sold as pure KMnO4 with no mention of fish, dosages or koi use. As this is a chemical that has many uses it will be on sale but not as a medicine.
From what I can glean at this point all anesthetics will be for vet use only. So no Eugenol, MS-222 or comparable will be available. Topical treatments if used to fight illness will require the presents of a licenced Veterinarian. No more DIY.
As of October 1st 2005 the ban has already taken effect though we are now in a transition phase that will end as of November 2007.

The sad thing is that this has been in the pipeline for quite some time and any number of organisations and hobby related periodicals could have made us (the koi hobby) aware of what was about to happen. This would have given us the capacity to raise our voices in protest and lobby the appropriate agencies for a bit of flexibility within the law pertaining to our hobby.

Realise that a Koi Mag that had ties with a company like Tetra would risk losing a client if they were to start shouting about this from the rooftops and thereby endangering the companies impending near-monopoly. But what is this all about, adds and making money or sustaining the koi hobby. I fear the lines have been drawn.

Now I fear it is too late and as of November next year many people are going to be in for a shock when they try to purchase what were up to that point normal supplies used in the koi hobby. They will find empty shelves of products that are of either too great a cost, insufficient quantity or both. The only recourse will be to have a vet make an expensive pond visit and hope that the good fellow has some basic understanding of how koi are diagnosed and treated.

IMO this whole subject is a much greater threat to the hobby that KHV and SVC combined. Things are about to change and the lack of interest and attention to this subject is absolutely pitiful.
For most of us the only option is to stock up and enjoy your supplies while they last!

B.Scott

[johnm]

This has been discussed on many UK forums, particularly the yorkshire koi society. The feeling here is that items such as malachite and formalin will still be available over the counter from dealers, as will pottassium permanganate, ms222 will be available, though not sure if this will be prescription only. Antibiotics will only be available from the vet, topical wound cleansers etc will still be available over the counter.

[B.Scott]

John,

The big problem here is the UK (and EU) aren't telling us exactly what is going on in plain words. The whole area is a big patch of grey.
The whole issue boils down to some simple facts.

• If a substance is used to "treat" any animals (ie fish) a license must be applied for.
• Anyone receiving a license will be forced to manufacture under approved EU laboratory conditions regarding safety, storage, waste management and product control.
• Any non-exempted products will be available only with the specific written prescription from a qualified vet.
• Prescribed substances must be for a single course of treatment only with a maximum water volume of 25,000 liters.
• Any issued substance must be approved for that specific treatment or the vet is liable to prosecution.

At this point in time you can buy certain substances and use them on your koi providing you do not purchase then as a treatment for koi. Possible contenders are things like sodium thiosulfate which you can purchase at a maximum of 1 liter per time (and then walk out of the store and return to buy a second liter) unless you buy it from a swimming pool supply store for your pool in which case you can buy a couple of gallons. KMnO4 in a maximum amount of 35 grams unless you wish to clean the canvas of your tent in which case you can buy a kilo.

At this point in time there is ONE approved dealer in the UK for pond meds and that is British King Products which produce for the aquarium trade and are not of any use to the pond hobby. http://www.vmd.gov.uk/ProductInfo/AuthMed/small.htm.
Tetra has also applied but has yet to be approved. Kasuri doesn't expect to get an approval and is in the process of closing down it's line of koi-med products.

Now certain products will be available through your local vet BUT there are some big problems involved here. The vet may prescribe a single course of treatment and only prescribe those drugs that have been approved for a specific treatment. Do you wish to anesthetize a fish? Then you may buy a single treatment of MS-222. If you widh to use benzocaine or 2-Phenoxyethanol or even Eugenol, you are stuffed. While these products do an excellect job they are NOT APPROVED for use with koi. To do so would be breaking the law. The same applies for most antibiotics. If you want Nufloor, Azactam or any other in a large arsenal of antibiotics you will have to buy them on the black market because they are not approved for fish.

Topical treatments are up in the air at this point. The law states all exempted treatments must be applied through the water So if you wish to apply them directly to a wound you must go to a vet and as yet none of these treatments has been approved for fish. You can buy orthobase sealer to keep your dentures in place but don't put it on your fish, you will be breaking the law.

With a maximum treatment ceiling of 25,000 liters you will be forced to make multiple trips if you need to treat a large pond. Accordingly the price will be very high for many small treatments.

I still have a lot to find out but I'll let you know as I glean more info.

B.Scott

[Bruno]

Hi, some explanatory notes were published in one of our UK racing pigeon magazines last year. Have posted cut-down version for your info.

British Homing World October 7th,2005

Veterinary Medicines – Small Animal Exceptions Scheme.

New regulations will be published that contain an exemption from the requirement for a marketing authorisation (ma) for certain veterinary medicines.



This exemption scheme applies to veterinary medicines labelled exclusively for use in one or more of the following animals: aquarium fish, cage birds, ferrets, homing pigeons, rabbits, small rodents and terrarium animals.



A draft guidance and information note (14) is enclosed, also available at www.vmd.gov.uk



Further questions about the scheme to: s.hack@vmd.defra.gov.uk





Small Animal Exceptions Scheme (saes) – Information Note



A public consultation was held in January 2004. A guide to the actions needed to market a product under the saes scheme is given. The regulations come into effect on 30th October 2005 but certain parts of saes have been deferred until 1st November 2007.



Products currently on the market without an ma:



..may only be administered to the groups of animals included in the scheme – other species must be deleted from the indications.



Products which are antibiotics, narcorics, or psychtropic drugs must be withdrawn from sale, as these do not fall under the scheme. Products must not be for parenteral or ophthalmic administration or for administration into the ear canal. Fish treatments administered via the water but not intended for ophthalmic administration are permitted.



Products that you wish to market after 1st November 2007 (including current products)

1. Submit the active ingredient details to us
   
   
   
2. We will consider these and inform you of our decision
   
   
   
3. We will publish ingredients we deem suitable to be included in the scheme
   
   
   
4. Apply for ma
   
   
   
5. If manufactured overseas, ensure site has ma license AND import license
   
   
   
6. Amend the product labelling ‘this veterinary medicine is marketed in accordance with the saes’
   
   
   
7. Ensure pack sizes are only sufficient for single course of treatment
   

Standard format for active substance details



Name of active substance

Standard English name, for herbs use Latin species name.

Species to which substance will be administered



Ornamental fish, pigeons, cage birds, terrarium animals (reptiles, amphibians, insects) small rodents (specify hamsters, guinea pigs, mice, rats, chinchillas or others) rabbits, ferrets.



Indications



The name of the disease to be treated.



Route of administration



Specify topical, oral, or any other route.



The pack size



The maximum pack size that will be marketed.



The concentration of the active substance



Use standard terms of mg/ml, mg/tablet etc.



The directions for use



The dosage rate, frequency of treatment and any other information to be provided to the user.



Your justification for requiring this substance in the scheme



Provide information on alternative authorised products (or lack of) welfare issues if product were to be lost from the market, experience of safe use (including date of first use / length of time product has been on market) and any other information you consider helpful. Please do not submit any studies or reports unless requested.







As you can see there's a web address for the legislation - beware runs to 115 pages ; and a contact email address for getting reliable answers to any questions you may have. Hope this helps.

[marco]

Quote: Originally Posted by B.Scott John, The vet may prescribe a single course of treatment and only prescribe those drugs that have been approved for a specific treatment. Do you wish to anesthitize a fish? Then you may buy a single treatment of MS-222. If you widh to use benzocane or 2-Phenoxyethanol or even Eugenol, you are stuffed. While these products do an excellect job they are NOT APPROVED for use with koi. To do so would be breaking the law. The same applies for most antibiotics. If you want Nufloor, Azactam or any other in a large arsenal of antibiotics you will have to buy them on the black market because they are not approved for fish. B.Scott

Hi Scott, it's not so complicated, if a treatment has been aproved for fish (MS-222 for exp) the vet won't be allowed to give or to use an other one wich is not aproved (benzocaïne) BUT if no treatment at all has been aproved for a specific pathology, the vet will be allowed to use a product that he think suitable ,as soon as the animal won't be eaten.

I don't know what will be the solution for most of the hobbist, maybe some koïclub could have a vet between the members that will find a local solution.
I agree that most of vet doesn't know a lot about koi pathology, but I suppose a lot of them will be interested to find discover something new (i meen only interest, not money). Maybe they will know a little more about drugs then the guy who take care of a petshop or who sell the drugs at the moment.
Any way that could also stop some people to use drugs like salt and peper in a kitchen, without knowing their toxicity.

IMHO the solution could be in the koïclub organisation.

Marco