8 July 2016 EMA/CVMP/477115/2016 Committee for Medicinal Products for Veterinary Use (CVMP)

Committee for Medicinal Products for Veterinary Use Draft agenda of July 2016 meeting

Chair: David Murphy Vice-chair: vacant 12 July 2016, 09:00 – 14 July 2016, 13:00 - Room 2A Declaration of interests In accordance with the Agency’s revised policy and procedure on the handling of declarations of interests, participants in this meeting are asked to declare any interests on the matters for discussion (in particular any changes, omissions or errors to the already declared interests). Discussions, deliberations and voting will take place in full respect of the restricted involvement of Scientific Committee members and, where relevant, experts attending the plenary meeting, as announced by the Scientific Committee Secretariat at the start of meeting. Disclaimers Some documents mentioned in the agenda/minutes cannot be released at present within the framework of Regulation (EC) No 1049/2001 on access to documents because they are subject to ongoing procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). i.

Adoption of the Agenda

ii.

CVMP delegates list of intended participation and identified conflicts of interests

iii.

Declaration of contacts between members and companies with regard to points on the agenda

iv.

Adoption of the minutes of the previous meeting

v.

Confirmation of topics for rapporteur’s meetings and breakout sessions Scientific Advice Working Party (room 2A)

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

Tue 12 Month 2016

16.00-20.00

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

1.

ESTABLISHMENT OF MAXIMUM RESIDUES LIMITS

1.1

Opinions



Substance

For adoption: CVMP opinion,

EMEA/V/MRL/003298/MODF/0004

CVMP assessment report

Bovine milk



Substance

For adoption: CVMP opinion,

EMEA/V/MRL/0031518/EXTN/0003

CVMP assessment report

Extension to ovine species

1.2 • 1.3 •

For information: Summary of opinion

For information: Summary of opinion

Oral explanations and list of outstanding issues No items List of questions Substance

For adoption: CVMP scientific overview and list of

EMEA/V/MRL/003596/FULL/0002

questions

Honey 1.4 • 1.5 •

Re-examination of CVMP opinions No items Other issues No items

2.

COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS

2.1

Opinions



Product

For adoption: CVMP opinion, CVMP assessment report,

EMEA/V/C/004239/0000

product information

New vaccine Rabbits 2.2 •

For information: Summary of opinion

Oral explanations and list of outstanding issues Product EMEA/V/C/0003993/0000 New vaccine Pigs

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

For decision: Need for oral explanation For adoption: Scientific overview and list of questions, comments on product information

Page 2/12

2.3 •

List of questions EQUIOXX EMEA/V/C/000142/X/0015 Extension to add a new pharmaceutical

Rapp: J. G. Beechinor Co-rapp: M. Azevedo Mendes

form

For adoption: Scientific overview and benefit-risk

Horses

assessment and list of questions, comments on product information



Product

For adoption: Scientific overview and benefit-risk

EMEA/V/C/004247/0000

assessment and list of questions, comments on product

New antiparasitic product

information

Dogs •

Product

For adoption: Scientific overview and list of questions,

EMEA/V/C/004376/0000

comments on product information

New product for psycholeptic use Dogs and cats •

Product

For adoption: Scientific overview and list of questions,

EMEA/V/C/004375/0000

comments on product information

New product for disorders of the musculo-skeletal system Dogs 2.4 •

Re-examination of CVMP opinions DRAXXIN EMEA/V/C/000077/X/0029 Extension to include a new target

Rapp: C. Friis Co-rapp: G. Beechinor

species

For adoption: Composition of AHEG, list of proposed

Cattle, pigs

experts, draft assessment by the rapporteurs, draft LoQ for AHEG For discussion: Comments from co-rapporteur

2.5 •

Other issues No items

3.

VARIATIONS TO COMMUNITY MARKETING AUTHORISATIONS

3.1

Opinions



Suvaxyn Circo+MH RTU EMEA/V/C/003924/II/0002 Quality



Comfortis, Trifexis EMEA/V/C/002233/WS0906/0016/G EMEA/V/C/002635/WS0906/0009/G

Rapp: B. Urbain For adoption: CVMP opinion, CVMP assessment report, product information Rapp: C. Ibrahim For adoption: CVMP opinion, CVMP assessment report

Quality •

Vectormune ND EMEA/V/C/003829/II/0004 Quality

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

Rapp: F. Klein For adoption: CVMP opinion, CVMP assessment report

Page 3/12



BLUEVAC BTV8 EMEA/V/C/000156/II/0007 Quality

3.2 • 3.3 •

No items List of questions Stronghold Quality

• 3.5 •

For adoption: CVMP opinion, CVMP assessment report

Oral explanations and list of outstanding issues

EMEA/V/C/000050/II/0055/G

3.4

Rapp: E. Werner

Rapp: H. Jukes For adoption: List of questions

Re-examination of CVMP opinions No items Other issues Activyl Tick Plus EMEA/V/C/002234/II/008 To add a new therapeutic indication

Rapp: J. Schefferlie Co-rapp: R. Breathnach For adoption: Request for extension of clock stop

4

REFERRALS AND RELATED PROCEDURES

4.1

Article 33 of Directive 2001/82/EC

• 4.2 •

No items Article 34 of Directive 2001/82/EC Denagard 45% and associated names EMEA/V/A/114

Rapp: C. Ibrahim Co-rapp: C. Muñoz Madero

Tiamulin hydrogen fumarate

For decision: Request from Elanco Animal Health for a

SPC harmonisation

1-month delay for the submission of responses to the list of outstanding issues



Girolan and its associated name Apralan EMEA/V/A/122

Rapp: to be appointed Co-rapp: to be appointed

Apramycin sulfate

For discussion and decision: Notification from Spain

SPC harmonisation

under Article 34 of Directive 2001/82/EC and Annex to notification Appointment of rapporteur, co-rapporteur and peer reviewers For information: List of products concerned

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

Page 4/12



Lincocin and its associated names

Rapp: to be appointed

EMEA/V/A/123

Co-rapp: to be appointed

Lincomycin

For discussion and decision: Notification from the

SPC harmonisation

European Commission under Article 34 of Directive 2001/82/EC and Annex to notification Appointment of rapporteur, co-rapporteur and peer reviewers For information: List of products concerned 4.3 •

Article 35 of Directive 2001/82/EC Veterinary medicinal products

Rapp: C. Ibrahim

containing moxidectin to be

Co-rapp: C. Muñoz Madero

administered to cattle, sheep and horses

Background note: N/a

EMEA/V/A/116

For decision: Request from Zoetis for a 2-month delay

Environmental risk assessment

for the submission of responses to the list of outstanding issues



Veterinary medicinal products

Rapp: B. Urbain

containing gentamicin presented

Co-rapp: H. Jukes

as solutions for injection to be administered to cattle and pigs

For information: Letter from Laboratorios Hipra and

EMEA/V/A/117

EMA response

Withdrawal periods •

Veterinary medicinal products

Rapp: to be appointed

containing tylosin that are

Co-rapp: to be appointed

administered parenterally and intended for the treatment of

For discussion and decision: Notification from Finland

bovine mastitis caused by

under Article 35 of Directive 2001/82/EC

Mycoplasma spp.

Appointment of rapporteur, co-rapporteur and peer

EMEA/V/A/121

reviewers

Efficacy

For information: List of products concerned 4.4 •

Article 45 of Regulation 726/2004 Velactis EU/2/15/192/001-004 Animal safety See also 5.5

Rapp: W. Schlumbohm Co-rapp: E. Lander Persson ORAL EXPLANATION – Tuesday 12 July, 14:00 For adoption: CVMP opinion, CVMP assessment report For discussion: Rapporteur’s revised assessment report; presentation from MAH

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

Page 5/12

4.5 • 4.6 • 4.7 •

Article 13 of Regulation (EC) No 1234/2008 No items Article 30(3) of Regulation 726/2004 No items Other issues No items

5.

POST-AUTHORISATION ISSUES FOR COMMUNITY MARKETING AUTHORISATIONS (EXCLUDING VARIATIONS)

5.1

General issues

• 5.2 •

No Items Post-authorisation measures and annual reassessments EVALON EMEA/V/C/004013/ANX/001-002

Rapp: N. Garcia del Blanco Co-rapp: B. Zemann For adoption: Rapporteurs’ assessment report

5.3

Product anniversary list

Product

Period

Canigen L4 (EMEA/V/C/004079

03/07/2015 – 02/07/2016

Circovac (EMEA/V/C/000114

21/06/2015 – 20/06/2016

Convenia (EMEA/V/C/000098

19/06/2015 – 18/06/2016

Equilis Prequenza (EMEA/V/C/000094

08/07/2015 – 07/07/2016

Equilis Prequenza Te (EMEA/V/C/000095

08/07/2015 – 07/07/2016

Equilis Te (EMEA/V/C/000093

08/07/2015 – 07/07/2016

EQUIOXX (EMEA/V/C/000142

25/06/2015 – 24/06/2016

ERYSENG (EMEA/V/C/002761

04/07/2015 – 03/07/2016

ERYSENG PARVO (EMEA/V/C/002762

08/07/2015 – 07/07/2016

Innovax-ILT (EMEA/V/C/003869

03/07/2015 – 02/07/2016

LEUCOFELIGEN FeLV/RCP (EMEA/V/C/000143

25/06/2015 – 24/06/2016

LEUCOGEN (EMEA/V/C/000144

17/06/2015 – 16/06/2016

Melovem (EMEA/V/C/000152

07/07/2015 – 06/07/2016

Posatex (EMEA/V/C/000122

23/06/2015 – 22/06/2016

PRILACTONE (EMEA/V/C/000105

20/06/2015 – 19/06/2016

ProZinc (EMEA/V/C/002634

12/07/2015 – 11/07/2016

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

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Product

Period

Reconcile (EMEA/V/C/000133

08/07/2015 – 07/07/2016

Suprelorin (EMEA/V/C/000109

10/07/2015 – 09/07/2016

Versican Plus DHPPi (EMEA/V/C/003679

04/07/2015 – 03/07/2016

Versican Plus Pi (EMEA/V/C/003681

04/07/2015 – 03/07/2016

5.4 • 5.5 •

Renewals No items Pharmacovigilance - PSURs and SARs For discussion: Signal detection findings from Rapporteur on adverse events reports for Velactis - See also 4.7



COXEVAC EMEA/V/C/000155

Rapp: J-C. Rouby For adoption: CVMP assessment report on the PSUR for the period 01.04.15-31.03.16



Dexdomitor EMEA/V/C/000070

Rapp: F. Hasslung Wikström For adoption: CVMP assessment report on the PSUR for the period 01.03.13-29.02.16



NexGard EMEA/V/C/002729

Rapp: P. Hekman For adoption: CVMP assessment report on the PSUR for the period 01.09.15-29.02.16



Nobilis IB 4-91 EMEA/V/C/000036

Rapp: N. Garcia del Blanco For adoption: CVMP assessment report on the PSUR for the period 01.10.15-31.03.16



Nobilis IB Primo QX EMEA/V/C/002802

Rapp: N. Garcia del Blanco For adoption: CVMP assessment report on the PSUR for the period 01.10.15-31.03.16



Nobivac Bb EMEA/V/C/000068

Rapp: N. Garcia del Blanco For adoption: CVMP assessment report on the PSUR for the period 01.04.13-31.03.16



Proteq West Nile EMEA/V/C/002005

Rapp: J-C. Rouby For adoption: CVMP assessment report on the PSUR for the period 01.03.15-29.02.16



Purevax Rabies EMEA/V/C/002003

Rapp: B. Urbain For adoption: CVMP assessment report on the PSUR for the period 01.03.15-29.02.16

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

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Suprelorin EMEA/V/C/000109

Rapp: E-M. Vestergaard For adoption: CVMP assessment report on the PSUR for the period 01.02.15-31.01.16



Vectormune ND EMEA/V/C/003829

Rapp: F. Klein For adoption: CVMP assessment report on the PSUR for the period 08.09.15-31.03.16



ZULVAC 1 Ovis EMEA/V/C/002335

Rapp: P. Pasquali For adoption: CVMP assessment report on the PSUR for the period 01.03.15-29.02.16



ZULVAC 1+8 Ovis EMEA/V/C/002251

Rapp: P. Pasquali For adoption: CVMP assessment report on the PSUR for the period 01.04.15-31.03.16

• 5.6

For endorsement: List of products and calendar for signal detection analysis Supervision and sanctions

Information relating to GMP and Pharmacovigilance inspections will not be published as it would be undermining the purpose of such inspections 6.

CO-OPERATION WITH OTHER EU OR INTERNATIONAL BODIES

6.1

VICH



For endorsement: Draft EU comments on VICH GL22 on Reproduction testing and inclusion of the extended one generation reproduction toxicity study



For endorsement: Draft VICH GL56 on Studies to evaluate metabolism and residues kinetics of veterinary drugs in food producing species: study design recommendations for residues studies in honey for establishing MRLs and withdrawal periods, for sign-off at step 2



For information: Report from 33rd VICH Steering Committee meeting and 7th Outreach Forum meeting

6.2

Codex Alimentarius

Information on certain topics discussed under section 6.2 cannot be released at the present time as it is deemed to be confidential 6.3

Other EU bodies and international organisations

Information on certain topics discussed under section 6.3 cannot be released at the present time as it is deemed to be confidential 7.

WORKING PARTIES AND SCIENTIFIC ADVISORY GROUPS

Information on certain topics discussed under section 7 cannot be released at the present time as it is deemed to be confidential

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

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7.1

Scientific Advice Working Party (SAWP-V)

Information relating to SAWP-V procedures cannot be released at the present time as it is deemed to be commercially confidential 7.2

Quality Working Party (QWP)

7.3

Safety Working Party (SWP-V)

7.4

Environmental Risk Assessment Working Party (ERAWP)

7.5

Efficacy Working Party (EWP-V)

7.6

Antimicrobials Working Party (AWP)

7.7

Immunologicals Working Party (IWP)

7.8

Pharmacovigilance Working Party (PhVWP-V)

7.9

Novel therapy groups and related issues

7.10

Joint CVMP/CHMP AHEG on the application of the 3Rs

7.11

Other working party and scientific group issues

8.

OTHER SCIENTIFIC MATTERS

8.1

MRLs issues

Information on certain MRL related issues cannot be released at the present time as it is deemed to be confidential 8.2

Environmental risk assessment

Information on certain Environmental risk assessment related issues cannot be released at the present time as it is deemed to be confidential • 8.3 •

No items Antimicrobial resistance For adoption: Updated advice of the Expert Advisory Group on Antimicrobial Resistance (AMEG) on the use of colistin products in animals within the European Union; overview of comments received on the publication of the updated advice on the use of colistin during the consultation period



For information: Verbal report on the Reduction of the Need for Antimicrobials in Food Producing Animals (RONAFA) teleconference held on 22 June



For information: Verbal report on the 2nd Joint Inter-agency Antimicrobial Consumption and Resistance Analysis (JIACRA) teleconferences held on 14 June, 28 June, 11 July

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

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8.4

Pharmacovigilance

Information on certain topics discussed under section 8.4 cannot be released at the present time as it is deemed to be confidential 8.5

Other issues

Information on other critical issues related to centralised procedures cannot be released at the present time as it is deemed to contain commercially confidential information •

For endorsement: Presentation by the CVMP representative for the Horizon 2020 project PARAGONE Vaccines for animal parasites - consortium meeting to be held in Ghent, Belgium on 29-30 August, 2016

9.

AVAILABILITY OF MEDICINES AND MUMS CLASSIFICATION

Information relating to availability of medicines cannot be released at the present time as it is deemed to be commercially confidential 10.

PROCEDURAL AND REGULATORY MATTERS

10.1

Eligibility and appointment of rapporteurs, co-rapporteurs and peer reviewers

Information relating to notification of intent for new MRL applications and notification of intent and eligibility requests for community marketing authorisations cannot be released at the present time as it is deemed to be commercially confidential •

For decision: Transfer of rapporteurships from D. Murphy to G. Beechinor

10.2

Regulatory matters

Information relating to certain regulatory issues cannot be released at the present time as it is deemed to be commercially confidential 11. •

CO-ORDINATION GROUP FOR MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES For information: Draft agenda of the CMDv meeting to be held on 14-15 July 2016, draft minutes of the meeting held on 16-17 June 2016; presentation by the CMDv chair

12. •

ORGANISATIONAL AND STRATEGIC MATTERS For endorsement: Revision of procedure for nomination and appointment of co-opted members in CHMP, CVMP and HMPC



For decision: Election of the vice-chair of CVMP (3-year term) at the July 2016 CVMP meeting



For decision: Verbal report on the survey results concerning appointment of rapporteurs for CVMP procedures; summary report, individual responses; next steps



For discussion: Appointment of CVMP co-opted members at the October 2016 meeting; identification of expertise necessary for CVMP to accomplish the mandate and appointment of coopted members, CVMP list of expertise - 2016



For discussion: Revised VNeeS format requirements guideline coming into force on 1 July 2016 – revision of Exceptions to VNeeS format document

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

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For discussion: CVMP/CMDv Presidency meeting held on 27-28 June 2016 in the Netherlands; final agenda, presentation on summary and conclusions



For information and discussion: Annual report 2015 on the performance of the Agency’s scientific procedures: Key Performance Indicators (KPIs) for medicinal products for human and veterinary use



For information: Verbal report from the Strategic Planning Group (SPG) to be held on 12 July 2016, draft agenda; draft minutes from the meeting held on 16 March 2016



For discussion: Revision of the documents on dossier submission requirements to commence following the July 2016 CVMP plenary meeting



For information: Council Decision of 29 May 2016 on the appointment of four Management Board members, including veterinary representative



For information: Update on EU Network Training Centre project – Veterinary curriculum



For information: Information on potential issues or procedures that would require CVMP decision(s) via written procedure during August 2016

13. •

LEGISLATION For information: Update on development of CVMP recommendations for Methodological principles for the risk assessment and risk management recommendations (“Volume 8”)

14. •

ANY OTHER BUSINESS For comments: Press release of the meeting

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

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ANNEX NEXT MEETINGS OF THE CVMP AND OF ITS WORKING PARTIES CVMP

ADVENT

AWP

ERAWP

EWP

IWP

PhVWP

QWP

SA

SWP

3R’s

WP Jul 2016

12-14

Sep 2016

6-8

Oct 2016

4-6

Nov 2016

8-10

Dec 2016

6-8

5/6 22-23 6

13-14 11-12

Committee for Medicinal Products for Veterinary Use EMA/CVMP/477115/2016

19-21 20-21

29-30 14-15

12 6

22-23

4 29-30

8

1

6

18-19 24-25

Page 12/12

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