Review/Oorsig Volume 22, Issue 04 - Page 32

Oorsig/Review HALOCUR – FRIEND OR FOE? NF- 23 Nov 2017 It looks like the Cryptosporidium problem is exploding. To my knowledge the only active that really works is halofuginone. This product is registered in several countries but not in SA yet. Many vets bring it in after obtaining a Section 21 permit from MCC. This however, is not an easy process and it takes some time. By the time you have product, the calves are dead. I know that the dossier for registration in SA has been submitted to the MCC. MF- 25 Nov 2017 (Translated from Afr. – Ed) My first permit application for Halocur took approx. 1 year, but now it goes a lot quicker. However, to obtain the product in Europe sounds like a major effort. 4 Weeks after my permit was approved some product was sourced in Ireland and then it takes another 5 weeks to clear customs. All this while calves and lambs fall ill and die (one of my clients had to treat 400 lambs). It creates the impression that the people in charge of the registration of the product do not realise the impact of the condition. The Halocur that I have used has shown dramatic effect, provided it is used correctly and with commitment from the farmer. I have given this feedback to the people at Section 21. Good luck with the registration. I hope that it happens soon so that it will be easier and cheaper for everyone. LW - 25 May 2018 • • • • • • • Halocure, the only product registered for Crypto in the world, is really difficult to import through Section 21. (My application from 3 months ago has not been approved yet...., they came back with wanting proof of payment – which was included, then they wanted, lab results – which was included. Still waiting patiently). Is our practice the only vet practice, not winning? Or are there answers yet? I know MSD has applied for registration of Halocure many years ago. Is there anything we can do to fast tract the process? We are absolutely desperate! Do these emails ever reach the regulatory authorities? Are they even aware of the thousands of dead lambs and calves in the country? 32 MvV - 25 May 2018 The Veterinary Medicines Unit of the MCC currently receives about one Section 21 application for Halocur per day. As it is received it is forwarded to a member of the Veterinary Clinical Committee of the MCC for approval/ disapproval. If the documents are correct and the laboratory confirmation of the diagnosis is included, the application is approved within a day or two. I cannot comment on Liezel's application specifically, but there is no delay currently with applications for Halocur. WvN- 25 May 2018 I've sent 5 applications in for Halocur permits about two weeks ago. Faxed them through. Received all 5 this week. I was very surprised. Can't tell you that I've done something different? JC - 28 May 2018 By the time the diagnosis, laborious epidemiological report and eventual MCC release occurs AND the slow red tape/import procedure is eventually achieved a huge number of calves and lambs are affected with huge economic loss to the livestock sector and to the reputation of the veterinary profession. Why can the product not be made readily available from the ‘shelf’ in South Africa so that the disease can be addressed within 24-72 hours and not the weeks it takes. To quote Moritz “the MCC currentl ɕٕ́Ё)Mѥāѥȁ!ȁȁtM)Ё́ѡ͕ٕ́ɔѡЀȁѠ́ɕѕ)ݡЁ́ѡѽѡ̃aѥѡɟd=)͔́ЁѕѼͥչ́)ɕɕ͕́ձѥ䁱ٕѽȁ͔M)ݡЁ́ѡɕ͔́ɍٕѡ䁽)ѕɕЁѼɕѕȁѡ!)Q! UII9PM%QUQ%=8)Qݥ́ݕɔ͕ЁѼ)ݕɔЁՉ͡ѡIɅٕЁ͍ͥ)մ)Q<)հ)ЁɕЁIYM4́ٽѕ)IYMѼɽՍ͡Ё͕́յа)Ёɵ̰ѥѱq ѽɥմ)եϊtQѥɅЁ݅́ɥѕ)ɥMɐѼݡݔɔЁɅѕհ)Qɕѽ́IYMݽձɕє)Ё՝ѕ́Ѽѡ