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European Regulation 2019/6 on VMPs: Implications on Innovation



After a lengthy process of nearly 10 years, the new regulation on veterinary medicinal products (VMPs) has been published on January 8th, 2019 to come into force on January 28th, 2022. The new regulation constitutes of three parts: regulation 2019/4 on medicated feed, regulation 2019/5 amending regulation 726/2004 and regulation 2019/6 replacing directive 2001/82 as amended. One of the major objectives of a new veterinary regulation was to foster innovation. Dr Klaus Hellmann and Dr Regina Wolf of Klifovet run through those articles that will influence innovation and thus the availability of VMPs in the EU.

DATE » 11.04.2019

AUTHORS » CEO, Klifovet AG, Dr. Klaus Hellmann Head of Regulatory Affairs, Klifovet AG, Dr. Regina Wolf

PUBLISHED » International Animal Health Journal
https://www.animalhealthmedia.com/european-regulation-2019-6-on-vmps-implications-on-innovation/


Publications in Magazines - 21.11.2024





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Quality Assurance and Remote Site Audits in Veterinary Clinical Field Studies 30.07.2021 | ht ... EMA/CVMP proposals for the requirements for limited markets and minor species: an update in 2021 30.03.2021 | https://www ... A Guide to Electronic Data Capture in Veterinary Clinical Studies 26.01.2021 | International Animal Health Journal, Volume 7, Issue 4 The Multicomponent, Multitarget Therapy SUC in Cats with Chronic Kidney Disease: A Multicenter, Prospective, Observ ... 18.01.2021 | Complement Med Res 2020;27:163–173 DOI: 10.1159/000506698 Received: February 7, 2019 Accepted: February 20, 2020 ... Products for Shaping the Gut Microbiome – Regulatory Opportunities and Challenges 18.11.2020 | https ... Proposals to Annex 2 of the European Regulation 2019/6 on VMPs 30.03.2020 | International Animal Health Journal <a href="https://www.animalhealthmedia.com/proposals-to-annex-2-of-the-european-regulati ... 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Network on Veterinary Medicines initiated by the European Federation for Pharmaceutical Sciences 31.10.2017 | Journal of Veterinary Pharmacology and Therapeutics, accepted, Oct. 2017 Efficacy of a single oral dose of a live bivalent E. coli vaccine against post-weaning diarrhea due to F4 and F18-p ... 08.08.2017 | The Veterinary Journal 2017, Available online 21 July 2017, ISSN 1090-0233 <a href="https://doi.org/10.1016/j.tvjl.2017.07.0 ... Evaluation of the Clinical Efficacy and Safety of a Spot-on Combination of Imidacloprid 10%/ Moxidectin 2.5% (Advoc ... 25.07.2017 | Parasitol Res (2017) 116:S65-S74 Free Access Article Randomised controlled field study to evaluate the efficacy and clinical safety of a single 8 mg/ kg injectable dose ... 06.06.2017 | Porcine Health Management (2017) 3:10 Open access: <a href="http://em.rdcu.be/wf/click?upn=lMZy1lernSJ7apc5DgYM ... Randomised controlled field study to evaluate the efficacy and clinical safety of a single 8 mg/kg injectabledose o ... 10.05.2017 | Porcine Health Management 2017 <a href="http://em.rdcu.be/wf/click?upn=lMZy1lernSJ7apc5DgYM8Qd7QFm5u6neFYUta5bXJ7U-3D ... Immunogenicity and protective efficacy of a single-dose live non-pathogenic Escherichia coli oral vaccine against F ... 05.12.2016 | Vaccine, available online 1 Dec 2016, ISSN 0264-410X <a class="S_C_ddDoi" href="http://dx.doi.org/10.1016/j.vaccine.2016.11. ... Position Paper: EUFEPS Network in Veterinary Medicines Initiative: an interdisciplinary forum to support Veterinary ... 27.07.2016 | European Journal of Pharmaceutical Sciences 91 (2016), I-VII; Elsevier Free Access link: <a href="http://www.sciencedirect.c ... The potential impact of animal welfare legislation on new veterinary medicines 01.03.2016 | Regulatory Rapporteur, Vol. 13, No. 4, April 2016 Inspections to VICH-GCP studies: EU Country Implementing Inspections of Field Investigational Sites 22.01.2016 | QUASAR, Issue 134, 4th International Edition, January 2016. Efficacy of a single dose of milbemycin oxime/ praziquantel combination tablets, Milpro®, against adult Echinococcu ... 11.12.2015 | DOI 10.1007/s00436-015-4855-7, Parasitol Res, pp. 1-8, Springer Berlin Heidelberg. Published online: 11 December 2015. Inspections to VICH-GCP studies: EU Country Implementing Inspections of Field Investigational Site 09.11.2015 | RQA magazine QUASAR, Issue 134. Preface Veterinary Parasitology, Volume 208 25.03.2015 | Veterinary Parasitology, Volume 208, Issues 1-2, Special issue: Vectors and Vector-Borne Infections The European Commission Authorises the Marketing of Prevtec Microbia's Coliprotec(R) F4 25.03.2015 | Press Release, 24MAR2015 <a href="http://www.marketwired.com/press-release/the-european-commission-authorises-the-marketing- ... Development of Veterinary Immunological and Biological Products - Now and Then? 18.03.2015 | IAJH - International Animal Health Journal, Volume 2, Issue 1 <a href="http://animalhealthmedia.com/wp-content/uploads/2015/ ... Regulatory Guidelines (Microbiology) for Veterinary Medicinal Antimicrobial Products 20.11.2014 | In: Industrial Pharmaceutical Microbiology: Standards & Controls Editors: Geoff Hanlon, Tim Sandle Edition 2015, E ... Improved Weight Gain in Calves by Addition of Digextra BB to the milk 05.11.2014 | Tierärztliche Umschau 69, 477-480 (2014) Field clinical study evaluating the efficacy and safety of an oral formulation containing milbemycin oxime/praziqua ... 21.08.2014 | Parasites & Vectors 2014, 7:347 Published: 29 July 2014 Antimicrobials for the animal health market 07.05.2014 | Regulatory Rapporteur – Vol 11, No 5, May 2014 Efficacy of deslorelin implants as the first line treatment of spayed bitches with clinical signs of urinary incont ... 07.07.2013 | 16th EVSSAR Congress (European Society of Small Animal Reproduction) Toulouse, France 5th - 7th July 2013 W.A.A.V.P. second edition: Guidelines for evaluating the efficacy of parasiticides for the treatment, prevention an ... 22.04.2013 | Veterinary Parasitology 194 (2013), 84-97 www.elsevier.com Antiparasitics as biocides or VMP: challenges and opportunities 10.04.2013 | 12th Int. Symposium on Ectoparasites in Pets. Munich, Germany 7. - 9. April 2013 Final Program and Proceedings<b ... 12th International Symposium on Ectoparasites in Pets (Proceedings) 10.04.2013 | 12th Int. Symposium on Ectoparasites in Pets. Munich, Germany 7. - 9. April 2013 Final Program and Proceedings<b ... Canine Hypothyreose - Wirksamkeit eines neuen L-Thyroxin-Prrparates (Wethyrox 4000g) bei täglicher Einmalgabe 03.04.2013 | Veterinärspiegel 1/2013, 11-16 Overview of Regulatory and Practical Aspects of Providing Veterinary Clinical Supplies to Investigational Centres i ... 30.01.2013 | In: QUASAR, Jan13, pages 17-19 Regulations for Borderline Products: Feed Additive versus Veterinary Medicinal Product 11.11.2012 | Part I: European Regulations. In MORE News about Feed Safety Borderline Products difficult to define and deal with 11.08.2012 | Review Article in: All About Feed, Vol. 20 No. 8 - 2012 Evaluation of the long-term efficacy and safety of an imidacloprid 10%/flumethrin 4.5% polymer matrix collar (Seres ... 15.05.2012 | Parasites & Vectors 2012, 5:66 doi:10.1186/1756-3305-5-66 Treatment of neonatal diarrhoea in calves with natural medicine compared to a standard therapy 31.01.2012 | Behandlung von KKlberdurchfall mit biologischen Prrparaten im Vergleich mit einer Standardtherapie Prakt Tierarzt (2012) 93; 150- ... Dirofilariosis in dogs in the Czech Republic - occurrence, therapy, and prevention 27.10.2011 | Veterinarstvi 2011; 61: 578-581 Field Evalutations of the Efficacy and Safety of Emodepside plus Toltrazuril (Procox(r) Oral Suspension for Dogs) a ... 08.08.2011 | Parasitol Res (2011) 09: 21-28 Behandlung von puerperaler Septikaemie und Toxaemie (MMA) bei Zuchtsauen mit biologischer Therapie im Vergleich zu ... 03.08.2011 | Tieraerztl. Umschau 66, 303-311 (2011) Evaluation of the Therapeutic and Preventive Efficacy of 2.5% Moxidectin/10% Imidacloprid (Advocate(r), Bayer Anima ... 26.07.2011 | Parasitol Res (2011) 109: S77-86 Effectiveness of the Homeopathic Preparation Zeel Compared with Carprofen in Dogs with Osteoarthritis 29.12.2010 | Journal of the American Animal Hospital Association 2011, 47, Jan/Feb p. 12-20 Efficacy and Safety of Emodepside 2.1%/Praziquantel 8.6 % Spot-on Formulation in the Treatment of Feline Aelurostro ... 11.08.2009 | Parasitology Research, Volume 105, Supplement 1, August 2009, p. 83-90 Efficacy and Safety of Imidacloprid 10%/Moxidectin 1% Spot-on Formulation n the Treatment of Feline Aelurostrongylo ... 11.08.2009 | Parasitology Research, Volume 105, Supplement 1, August 2008, p. 55-62 Field Evaluation of the Efficacy and Safety of Emodepside plus Praziquantel Tablets (Profender(r) Tablets for Dogs) ... 11.08.2009 | Parasitology Research, Volume ´05, Supplement ´, August 2009, p. 23-30 Prevalence of Serum Markers of Feline Chronic Kidney Disease for Quality of Life 13.03.2009 | In: Kleintiermedizin; 3, 2009 Page A24 Therapeutic and Metaphylactic Efficacy of Tulathromycin (DRAXXIN(r)) in Porcine Respiratory Disease in Europe Assoc ... 03.11.2008 | Tierärztliche Umschau / 2008, pages 6´5-620 Rickettsia felis in Fleas, Germany 29.10.2008 | Emerging Infectious Diseases, Vol. ´4 No. 8, Aug 2008 Metaphylaktische Wirksamkeit von Tulathromycin bei Schweinen während eines Ausbruchs von Bronchopneumonie in Slowen ... 26.08.2008 | Tierärztliche Umschau, 63, No. 8, Pages 419-425 Rickettsia felis in Fleas, France 29.04.2008 | Emerging Infectious Diseases, Vol. 14, No. 4, April 2008 Evaluation of the efficacy and safety of a novel formulation of metaflumizone in cats naturally infested with fleas ... 15.12.2007 | Veterinary Parasitology 2007, 50 (3): 246-250 * KLIFOVET AG; ** Fort Dodge Animal Health; *** Ludwig-Maximilian-University, Mun ... Evaluation of the efficacy and safety of a novel formulation of metaflumizone plus amitraz in dogs naturally infest ... 15.12.2007 | Veterinary Parasitology 2007; 50 (3): 239-245 Behandlung von degenerativen Gelenkserkrankungen des Hundes mit Zeel ad us. vet. im Vergleich zu Carprofen 20.08.2007 | Kleintiermedizin Nr. 7/8-07 Juli-August 2007 Bacteriological and virological status in upper respiratory tract infections in cats 09.03.2007 | Berl. Münch. Tierärztl. Wochenschr. 120, 120-125 (2007) Clinical Efficacy of Catosal in the Treatment of Ketosis of Cows 23.05.2006 | Tierärztl. 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