›› KLIFOVET › EXPERTISE › PUBLICATIONS


Proposals to Annex 2 of the European Regulation 2019/6 on VMPs



With the support of the EMA/ CVMP, the European Commission appears well on track with the process of drafting the delegated act (Art.146) on Annex II of the Regulation (EU) 2019/6. The scientific recommendations provided by EMA/CVMP on Annex II will require a variety of further guidance documents, which need to be adapted for the development of new and innovative products. Dr. Klaus Hellmann and Dr. Regina Wolf at Klifovet examine how the contents of Title IIa, Title III.8 and IV define new specific requirements to obtain marketing authorisations for non-immunological biological veterinary medicinal products (VMPs) and novel therapies.

DATE » 30.03.2020

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/proposals-to-annex-2-of-the-european-regulation-2019-6-on-vmps/



Publications in Magazines - 07.11.2024





Is it Safe & Effective? Clinical Studies Evaluating Veterinary Medicines: Increasing Focus on High Quality and Repr ... 18.10.2022 | <a href="https://international-animalhealth.com/is-it-safe-effective-clinical-studies-evaluating-veterinary-medicines-increasing-f ... Multicenter Randomized, and Blinded European Field Study Evaluating the Efficacy and Safety of Felpreva®, a Novel S ... 31.01.2022 | https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4064464< ... Multicenter Randomized, and Blinded European Field Study Evaluating the Efficacy and Safety of Felpreva®, a Novel S ... 19.01.2022 | https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4064463< ... Registration of Novel Parasiticides under the New 2022 EU Regulation 11.10.2021 | https://www.mdpi.com/2673-9976/5/1/2/pdf biology and ... We thank Zoetis for their acknowledgement in this publication: A prospective, randomized, blinded, placebo-controll ... 22.08.2021 | Veterinary Anaesthesia and Analgesia 2021, 48, 943-955 h ... 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 ... Innovation in the EU - trends and hurdles 10.12.2019 | REGULATORY RAPPORTEUR | Vol. 16, No 12, December 2019 Equine allogene chondrogen induzierte mesenchymale Stammzellen für eine wirksame Behandlung degenerativer Gelenkerk ... 28.06.2019 | Tierärztl. Umschau 74, 268-281 [2019] European Regulation 2019/6 on VMPs: Implications on Innovation 11.04.2019 | International Animal Health Journal <a href="https://www.animalhealthmedia.com/european-regulation-2019-6-on-vmps-implicatio ... Veterinary Medicinal Antimicrobial Products 12.03.2019 | Chapter 28 in: Industrial Pharmaceutical Microbiology, Standards & Controls. Editor Tim Sandle, 5th Edition, 2019. Publ. Eurom ... Equine allogeneic chondrogenic induced mesenchymal stem cells are an effective treatment for degenerative joint dis ... 09.01.2019 | <a abstractlink="yes" alsec="jour" alterm="Stem Cells Dev." aria-expanded="false" aria-haspopup="true" href=" ... Efficacy of a one-shot marbofloxacin treatment on acute pleuropneumonia after experimental aerosol inoculation of n ... 22.06.2018 | Porcine Health Management (2018) doi.org: 10.1186/s40813-018-0089-2 Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences. 20.12.2017 | J vet Pharmacol Therap. 2018;41:378–383. https://doi.org/10.1111/jvp.12472 Data Management in Veterinary Clinical Studies 20.12.2017 | International Animal Health Journal <a href="https://www.animalhealthmedia.com/category/volume-4-issue-4/page/2/" target="_b ... 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. Umschau 61 (4), 187,190 (2006) Comparison of the effect of Zeel ad us.vet. in lameness of horses caused by non-infetious arthropthy to the effect ... 29.03.2006 | Der Praktische Tierarzt 87: 5 (2006), 362-370 Clinical and epidemiological characteristics of Eimeria infections in first-year grazing cattle 28.03.2006 | Veterinary Parasitology 136 (2006), 215-221 Treatment of clinical mastitits with Advocid(r) 180 05.03.2006 | Grosstierpraxis 7:01, 38-41 (2006) Efficacy of toltrazuril as a metaphylactic and therapeutic treatment of coccidiosis in first-year grazing calves 24.10.2005 | Parasitol Res (2005) 97: 127-133 Field Evaluation of the Safety and Efficacy of Emodepside / Praziquantel spot-on solution against naturally acquire ... 24.10.2005 | Parasitol Res (2005), 97: 58-64 Efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of sarcoptic mange and otoaca ... 24.10.2005 | Parasitol Res (2005) 97: 81-88 Evaluation of the efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of generali ... 24.10.2005 | Parasitol Res (2005) 97: 89-96 Topical tea tree oil effective in canine localised pruritic dermatitis - a multi-centre randomised double-blind con ... 26.11.2004 | Deutsche Tierärztliche Wochenschrift, 10/2004 Teebaumöl bei Dermatitis mit Juckreiz - eine randomisierte Doppelblindstudie bei Hunden 16.07.2004 | Kleintiermedizin 5/6 (2004) Survey of the use of Cobactan 2.5% in veterinary practice: Small and companion animals 02.07.2004 | Survey of the use of Cobactan 2.5 % in veterinary practice: Horse 02.07.2004 | Tierärztliche Umschau 7, 410-411 (2004) Survey of the use of Cobactan suspension 2.5 % in veterinary practice: Swine 23.06.2004 | Tierärztliche Umschau 59, 356-358 Survey of the use of Cobactan suspension 2.5 % in veterinary practice: Cattle 23.06.2004 | Tierärztliche Umschau 59, 356-358 European multicenter field trial on the efficacy and safety of a topical formulation on Imidacloprid and Permethrin ... 19.08.2003 | Parasitol Res 90, 2003: 125-126 The anthelmintic efficacy and the safety of a combination of Imidacloprid and Moxidectin spot-on in cats and dogs u ... 19.08.2003 | Parasitol Res 90, 2003: 142-143 Recent investigation on the prevalence of gastrointestinal nematodes in cats from France and Germany 19.08.2003 | Parasitol Res 90, 2003: 146-147 Prävalenzen von Floharten bei Hunden (prevalence of flea species in dogs) 20.03.2003 | DVG Tagung der Fachgruppe Parasitologie, Leipzig, 20.-21. März 2003 A comparative field study of the efficacy of Cefquinome and Amoxycillin against acute meningitis of weaned piglets. 14.01.2003 | Pig Journal 50, 2002: 28-41 Die klinische Wirksamkeit von Cefquinom (Cobactan 2,5% Injektionslösung) in der Behandlung der Epidermitis exsudati ... 15.05.2002 | Tierärztliche Umschau 57(7), 2002: 367-374. Verkürzung der Messdauer bei der rektalen Temperaturmessung in der tierärztlichen Praxis 20.12.2001 | Tierärztliche Umschau 56(12), 2001: 657-661. Qualitätssicherung (QS) und Qualitätsmanagement (QM): Bedeutung für die tierärztliche Praxis (Teil 1) 31.08.2001 | Der Praktische Tierarzt 82(3) 2001, BPT Info: 8-9 Qualitätssicherung (QS) und Qualitätsmanagement (QM): Bedeutung für die tierärztliche Praxis (Teil 2) 01.04.2001 | Der Praktische Tierarzt, 82. Jg, 4.2001, BPT INFO, Seite 9 – 10 Qualitaetsmanagement (QM): Bedeutung fuer die tieraerztliche Praxis (Teil 1) 01.03.2001 | Der PraktischeTierarzt, 82 Jg,3.2001, BPT INFO, Seite 8 – 9 Comparative efficacy of Flunixin in the treatment of bovine enzootic pneumonia in cattle 01.03.2001 | Der Praktische Tierarzt, 82. Jg, 3.2001, Page 190-196 Die klinische Wirksamkeit von Danofloxacin 2,5% (Advocin(R)) bei der Behandlung von Escherichia coli-Infektionen so ... 05.01.2001 | Tierärztl. Umschau 5, 2001: 235-243 Efficacy of selamectin against experimentally induced and naturally acuired ascarid (Toxocara canis and Toxocara le ... 23.08.2000 | Veterinary Parasitology 91 (2000), 333-345 Subklinische Mastitis: Voraussetzung für Sanierung und Therapie 01.01.1993 | Tierärztliche Umschau 48, 356-364 Lipid Peroxidation in Boar Semen. A Relevant Aspect of Semen Storage? 01.01.1991 | Boar Semen Preservation II: Proceedings - Supplement 1 to: Reproduction of domestic animalsm, Paul Parey Verlag, Berlin und Hambur ...