Monthly report on application procedures, guidelines and related documents for veterinary medicines

Transcription

1 2 June 7 EMA/3737/7 Veterinary Medicines Division Monthly report on application procedures, guidelines and related documents for May 7 This report, which is updated every month, provides current information related to the volume and evaluation of pre- and post-authorisation applications for medicinal products for veterinary use received by the European Medicines Agency (EMA) for the current and previous three years on: scientific advice requests; applications for initial evaluations, extensions, variations and renewals concerning marketing authorisations (MAs); applications for initial evaluations, extensions, modifications and extrapolations for maximum residue limits (MRLs); arbitration and referral procedures; requests for classification and re-classifications of products as Minor Use Minor Species (MUMS)/limited market. In addition, the report includes a summary table of the opinions issued by the Committee for Medicinal Products for Veterinary Use (CVMP) in the current year, as well as a list of adopted guidelines and other public guidance documents. The purpose is only to provide ongoing factual information. Commentaries and analysis are provided in the Agency's annual reports. 3 Churchill Place Canary Wharf London E4 EU United Kingdom Telephone +44 () Facsimile +44 () 366 Send a question via our website An agency of the European Union European Medicines Agency, 7. Reproduction is authorised provided the source is acknowledged.

2 Statistics on pre- and post-authorisation applications for medicinal products for veterinary use Scientific advice requests Submitted and validated Advice given Scientific advice requests submitted and advice given Submitted Advice given 9 8 Initial evaluation of marketing authorisation applications Full (submitted) Abridged/generics (submitted) 4 3 Withdrawals 3 Positive opinions 4 7 Negative opinions Pre-authorisation: submissions of MA applications by type Pre-authorisation: outcome of the evaluation of MA applications Full (submitted) Abridged/generics (Submitted) Positive opinions Negative opinions EMA/3737/7 Page 2/

3 Marketing authorisations Granted Withdrawals 3 Refusal Not renewed Extensions applications Submitted Withdrawals Positive opinions 2 6 Negative opinions Variations applications submitted 4 6 Type-IA variations Type-IB variations Type-II variations Transfers Post-authorisation: submissions of variations and transfers Type IA variations Type IB variations Type II variations Transfers Renewals applications Submitted 24 3 Positive opinions 9 4 Negative opinions EMA/3737/7 Page 3/

4 Establishment of MRLs for new substances applications Submitted Withdrawals 2 Positive opinions 2,3 4 3 () 2 2 Negative opinions Extensions/modifications of MRLs 4 applications Submitted Withdrawals Positive opinions Negative opinions Review of opinions/extrapolations of MRLs requests from Commission or Member States Submitted 2 Opinion Substances considered as not falling within the scope of Regulation (EC) No 47/9 requests Submitted Agreed Not agreed 2 Scientific advice recommended MRL-related submissions New applications Extensions/modifications Review/extrapolations Out of scope Establishment of MRLs for new substances under article 3 of Regulation (EC) No 47/9. 2 Including opinions recommending the extension of the expiry date for provisional MRLs or definitive MRLs for substances previously with provisional MRLs. 3 Re-examinations of opinions are indicated in brackets. 4 Extension or modification of MRLs under article 3 of Regulation (EC) No 47/9. Review of opinions under article of Regulation (EC) No 47/9 or requests under article 27 of Regulation (EC) No 47/9. EMA/3737/7 Page 4/

5 MUMS/limited market (re)classification requests outcome MUMS/limited market with financial incentives MUMS/limited market without financial incentives MUMS/limited market reclassification with financial incentives 6 MUMS/limited market reclassification without 3 2 financial incentives 6 Not MUMS/limited market Outcome of MUMS/limited market (re-)classification requests MUMS with financial incentives MUMS without financial incentives Not MUMS Re-classification with incentives Re-classification without incentives Arbitrations and referrals Arbitrations and referrals submitted Opinions 7 () 7 4() Arbitrations and referrals submitssions and opinions Referrals submitted Opinions and re-examinations 6 For re-classification the first year available is 4. 7 Re-examinations of opinions are in brackets. EMA/3737/7 Page /

6 CVMP opinions in 7 on medicinal products for veterinary use Positive opinions Product Invented name INN/Common name Credelio Lotilaner CYTOPOINT Lokivetmab Zulvac BTV Ovis Bluetongue vaccine (inactivated) (multistrain: -2 strains out of a set of 3) Ingelvac PCV FLEX Porcine circovirus vaccine (inactivated) RESPIPORC FLUpan HN Swine influenza vaccine (inactivated) Zeleris Florfenicol/meloxicam Prevomax Maropitant Marketing Target species Regulatory information authorisation holder Procedure number Opinion date Elanco Europe Ltd Dog EMEA/V/C/4247/ 6/2/7 Zoetis Belgium SA Dog EMEA/V/C/3939/ 6/2/7 Zoetis Belgium SA Sheep EMEA/V/C/48/ 6/2/7 Boehringer Pig EMEA/V/C/464/ Ingelheim 6/3/7 Vetmedica GmbH IDT Biologika Pig EMEA/V/C/3993/ GmbH 6/3/7 CEVA Santé Cattle EMEA/V/C/499/ Animale 6/3/7 Le Vet Beheer B.V. Dogs, Cats EMEA/V/C/433/ 2/4/7 EMA/3737/7 Page 6/

7 CVMP opinions in 7 on establishment of MRLs Positive opinions Product Target species Regulatory information Substance Procedure number Opinion date Alarelin All food producing species EMEA/V/MRL/476/FULL/ 2/4/7 Bromelain Porcine EMEA/V/MRL/4479/FULL/ //7 EMA/3737/7 Page 7/

8 Arbitrations and referrals in 7 Ongoing procedures Type of procedure Date Clock start CVMP opinion Product Product name INN 34 of Directive /82/EC 3 of Directive /82/EC 3 of Directive /82/EC (re-examination) 3 of Directive /82/EC 3 of Directive /82/EC 34 of Directive /82/EC 34 of Directive /82/EC 3 of Directive /82/EC 9/9/ Denagard 4% and associated names 2/4/7 Tiamulin hydrogen fumarate // All veterinary medicinal products //7 containing moxidectin to be administered to cattle, sheep and horses Moxidectin 7/2/6 All veterinary medicinal products 8/2/6 containing zinc oxide to be 6/3/7 administered orally to food producing species Zinc oxide 8//6 Veterinary medicinal products 6/3/7 containing methylprednisolone hydrogen succinate presented as solutions for injection for intramuscular use in cattle Methylprednisolone hydrogen succinate 3/7/6 Veterinary medicinal products 6/3/7 containing tylosin to be administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp Tylosin 3/7/6 Girolan and its associated name Apralan Apramycin sulfate 3/7/6 Lincocin and associated names Lincomycin 7/9/6 Zanil and associated names, and generic products thereof Oxyclozanide EMA/3737/7 Page 8/

9 Guidelines and working documents in 7 CVMP quality EMA/CHMP/CVMP/QWP/BWP/42 83/6 EMA/CHMP/CVMP/QWP/82677/ 6 Draft Concept paper on the need for Revision of Note for guidance on quality of water for pharmaceutical use (H+V) Corrigendum to Reflection paper on the Requirements for selection and justification of starting materials for the manufacture of chemical active substances Adopted for consultation January 7 (End of consultation TBC) Adopted January 7 CVMP safety EMA/CVMP/SWP/37724/6 Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products Adopted for consultation February 7 (End of consultation 3 August 7) CVMP efficacy EMA/CVMP/344/999-Rev.2 EMA/CVMP/EWP/7336/3 EMA/CVMP/EWP/6/-Rev.3 Guideline on the conduct of efficacy studies for intramammary products for use in cattle Reflection paper on anthelmintic resistance Revised guideline on the conduct of bioequivalence studies for veterinary medicinal products Adopted January 7 Adopted April 7 Adopted for consultation April 7 (End of consultation 3 October 7) CVMP pharmacovigilance EMA/CVMP/PhVWP/722/6 Revised recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data for centrally authorised products (CAPs) Adopted for consultation February 7 (End of consultation 3 August 7) EMA/3737/7 Page 9/

10 EMA/CVMP/PhVWP/33762/2 - Rev. EMA/CVMP/PhVWP/3739/ Revised Questions and answers on serious non-fatal adverse events and reporting rules Reflection paper on nonspontaneous adverse event reports (literature, internet and social media) for veterinary medicinal products Adopted April 7 Adopted May 7 CVMP antimicrobials CVMP immunologicals EMA/CVMP/IWP/9262/4 EMA/CVMP/IWP/23243/6- Rev.3 CVMP Risk Management Strategy - Managing the risk of the potential presence of replication competent endogenous retrovirus RD4 in starting materials and final products of feline and canine vaccines Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market Adopted February 7 Adopted April 7 CVMP environmental risk assessment EMA/CVMP/ERA/3/ EMA/CVMP/ERA/6894/ EMA/CVMP/4482/ Guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater Guideline on the plant testing strategy for veterinary medicinal products Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vpvb) substances Adopted for consultation February 7 (End of consultation 3 August 7) Adopted March 7 Adopted April 7 EMA/3737/7 Page /

11 CVMP novel therapies Replacement, Reduction, Refinement of animal testing (3Rs) General EMA/CVMP/7793/6 Question and answer on the information contained within section. of the SPC on pharmacodynamic properties for pharmaceutical products Adopted February 7 EMA/3737/7 Page /