9 February 2018 EMA/CVMP/88236/2018 draft 3 Committee for Medicinal Products for Veterinary Use (CVMP)

Committee for Medicinal Products for Veterinary Use Draft agenda of February 2018 meeting

Chair: David Murphy Vice-chair: Helen Jukes 13 February 2018, 09:00 – 15 February 2018, 13:00 - Room 2A Declaration of interests In accordance with the Agency’s revised policy and procedure on the handling of competing 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 CVMP members and, where relevant, experts attending the plenary meeting, as announced by the CVMP 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.

Intended participation and competing 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 +44 (0)20 3660 6000 +44 (0)20 3660 5555 Telephone Facsimile Send a question via our website www.ema.europa.eu/contact

Tue, 13 Feb 18

16:00 – 20:00

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

1.

ESTABLISHMENT OF MAXIMUM RESIDUE LIMITS

1.1

Opinions



Substance

For adoption: CVMP opinion including EPMAR, CVMP

EMEA/V/MRL/003517/EXTN/0003

assessment report

Poultry eggs 1.2 •

For information: Summary of opinion

Oral explanations and list of outstanding issues Substance

For decision: Need for oral explanation

EMEA/V/MRL/003647/EXTN/0002 Porcine 1.3 •

List of questions Substance

For adoption: Scientific overview and list of questions

EMEA/V/MRL/004933/FULL/0001 Bovine 1.4 •

Re-examination of CVMP opinions Substance

For discussion: Rapporteur’s joint assessment report

EMEA/V/MRL/003135/MODF/0003 Salmonidae 1.5 •

Other issues No items

2.

COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS

2.1

Opinions



Product

For decision: Request from applicant for oral

EMEA/V/C/004440/0000

explanation at March CVMP

New antiparasitic product Cats

For adoption: Draft CVMP opinion, CVMP assessment report, product information For information: Summary of opinion



Product

For adoption: CVMP opinion, CVMP assessment report,

EMEA/V/C/004417/0000

product information

New product Dogs 2.2 •

For information: Summary of opinion

Oral explanations and list of outstanding issues Product EMEA/V/C/004222/0000 New product for a musculo-skeletal disorder

For decision: Need for oral explanation For adoption: Scientific overview and list of outstanding issues; comments on product information

Horses

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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Product EMEA/V/C/004265/0000 New product for a musculo-skeletal disorder

For decision: Need for oral explanation For adoption: Scientific overview and list of outstanding issues; comments on product information

Horses •

Credelio EMEA/V/C/004485/X/0001 To add a new strength for a new

2.3 •

For adoption: Scientific overview and list of

Dogs

outstanding issues; comments on product information

List of questions Zulvac BTV Ovis Extension to add a new target animal

• 2.5 •

Co-rapp: G. Kulcsár

target species

EMEA/V/C/004185/X/0001

2.4

Rapp: R. Breathnach

Rapp: N. Garcia del Blanco Co-rapp: F. Klein

species

For adoption: Scientific overview and list of questions;

Sheep

comments on product information

Re-examination of CVMP opinions No items Other issues Product

For decision: Request from applicant to extend clock-

EMEA/V/C/004291/0000

stop

New antiparasitic product Cattle •

Product

For decision: Request from applicant to extend clock-

EMEA/V/C/004611/0000

stop

New vaccine Sheep and cattle •

Product

For information: Letter of withdrawal of the marketing

EMEA/V/C/004375/0000

authorisation application

New product for a musculo-skeletal disorder Dogs 3.

VARIATIONS TO COMMUNITY MARKETING AUTHORISATIONS

3.1

Opinions



Metacam EMEA/V/C/000033/II/0127 To register an additional non-food producing target species

Rapp: F. Hasslung Wikstrom Co-rapp: G. Hahn For adoption: CVMP opinion, CVMP assessment report, product information For information: Summary of opinion

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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Oncept IL2, Parvoduk, ProteqFlu, Proteq West Nile, ProteqFlu Te, Purevax FeLV, Purevax Rabies, Purevax RC, Purevac RCP, Purevax

Rapp: B. Urbain For adoption: CVMP opinion For endorsement: Rapporteur’s assessment report

RCP FeLV, Pu8revax RCPCh, Purevax RCPCh FeLV, Vaxxitek HVT+IBD EMEA/V/C/xxxxxx/WS1195 Quality •

Porcilis PCV ID EMEA/V/C/003942/WS1277(0002) To change the SPC/leaflet wording concerning a precision regarding



For adoption: CVMP opinion, CVMP assessment report, product information

administration during associated use

For information: Summary of opinion

ERAVAC

Rapp: C. Muñoz

EMEA/V/C/004239/II/0003/G To amend the duration of immunity and extension of safety; related changes in



Rapp: P. Hekman

For adoption: CVMP opinion, CVMP assessment report, product information

the product information

For information: Summary of opinion

Vaxxitek HVT + IBD

Rapp: B. Urbain

EMEA/V/C/000065/WS1209/G Quality

For adoption: CVMP opinion For endorsement: Rapporteur’s assessment report



STARTVAC EMEA/V/C/000130/II/0005 Quality

Rapp: E. Werner For adoption: CVMP opinion, product information For endorsement: Rapporteur’s assessment report



Ingelvac CircoFLEX and Ingelvac PCV FLEC EMEA/V/C/xxxxxx/WS1249/G



Rapp: B. Urbain For adoption: CVMP opinion

Quality

For endorsement: Rapporteur’s assessment report

Vaxxitek HVT + IBD

Rapp: B. Urbain

EMEA/V/C/000065/WS1242 Quality

For adoption: CVMP opinion For endorsement: Rapporteur’s assessment report

3.2 •

Oral explanations and list of outstanding issues Porcilis ColiClos EMEA/V/C/002011/II/0007 Quality

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

Rapp: N. Garcia del Blanco For adoption: List of outstanding issues

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3.3 •

List of questions BTVPUR

Rapp: C. Muñoz

EMEA/V/C/002231/II/0010

Co-rapp: P. Pasquali

To add a new serotype

For adoption: List of questions •

CLYNAV

Rapp: N. Garcia del Blanco

EMEA/V/C/002390/II/0001/G

For adoption: List of questions

Quality 3.4 • 3.5 •

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

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 Girolan and its associated name Apralan EMEA/V/A/122 (re-examination)

4.3 •

Rapp: J. G. Beechinor Co-rapp: W. Schlumbohm

Apramycin sulfate

For adoption: Final CVMP opinion, final CVMP

SPC harmonisation

assessment report, product information

Article 35 of Directive 2001/82/EC Veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys

Rapp: H. Jukes Co-rapp: C. Muñoz For adoption: CVMP follow-up assessment report

EMEA/V/A/089 - Follow-up assessment Efficacy (dosing regimen for E. coli) •

Veterinary medicinal products containing 50 mg closantel per ml (as a single active substance)

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

presented as solutions for

For discussion and decision: Notification from the

injection for subcutaneous use in

United Kingdom under Article 35 of Directive

sheep

2001/82/EC

EMEA/V/A/126 Withdrawal periods

Appointment of rapporteur, co-rapporteur and peer reviewers For information: List of products concerned

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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4.4

Article 78 of Directive 2001/82/EC No items

• 4.5

Article 13 of Regulation (EC) No 1234/2008 Seresto



EMEA/V/A/125 Imidacloprid and flumethrin Efficacy 4.6

Rapp: H. Jukes Co-rapp: G. Hahn For adoption: CVMP opinion, CVMP assessment report

Article 30(3) of Regulation 726/2004 No items

• 4.7

Other issues No items

• 5.

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

5.1

General issues No items

• 5.2

Post-authorisation measures and annual reassessments No items

• 5.3

Product anniversary list

Product

Period

Bravecto (EMEA/V/C/002526)

11/02/2017 – 10/02/2018

Comfortis (EMEA/V/C/002233)

11/02/2017 – 10/02/2018

Fevaxyn Pentofel (EMEA/V/C/000030)

05/02/2017 – 04/02/2018

Hiprabovis IBR Marker Live (EMEA/V/C/000158)

27/01/2017 – 26/01/2018

Ingelvac CircoFLEX (EMEA/V/C/000126)

13/02/2017 – 12/02/2018

Kexxtone (EMEA/V/C/002235)

28/01/2017 – 27/01/2018

Loxicom (EMEA/V/C/000141)

10/02/2018 – 09/02/2018

NexGard (EMEA/V/C/002729)

11/02/2017 – 10/02/2018

Nobilis OR inac (EMEA/V/C/000062)

24/01/2017 – 23/01/2018

PIRSUE (EMEA/V/C/000054)

29/01/2017 – 28/01/2018

Semintra (EMEA/V/C/002436)

13/02/2017 – 12/02/2018

STARTVAC (EMEA/V/C/000130)

11/02/2017 – 10/02/2018

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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Stronghold Plus (EMEA/V/C/004194)

09/02/2017 – 08/02/2018

Suvaxyn CSF Marker (EMEA/V/C/002757)

10/02/2017 – 09/02/2018

VarroMed (EMEA/V/C/002723)

02/02/2017 – 01/02/2018

ZULVAC SBV (EMEA/V/C/002781)

06/02/2017 – 05/02/2018

5.4 •

Renewals Meloxidolor EMEA/V/C/002590/R/0007

Rapp: C. Muñoz Co-rapp: M. Turk For adoption: List of outstanding issues



ProZinc EMEA/V/C/002634/R/0013

Rapp: R. Breathnach Co-rapp: S. Louet For adoption: CVMP opinion, CVMP assessment report, product information

5.5 •

Pharmacovigilance - PSURs and SARs Bravecto EMEA/V/C/002526

Rapp: G. J. Schefferlie For discussion: Draft revised assessment report on the PSUR for the period 01.03.17 - 31.08.17



Versican Plus L4 EMEA/V/C/003680



Versican Plus Pi L4 EMEA/V/C/003683



Versican Plus Pi L4R EMEA/V/C/003682



Aivlosin EMEA/V/C/000083

Rapp: E. Werner For adoption: CVMP assessment report Rapp: E. Werner For adoption: CVMP assessment report Rapp: E. Werner For adoption: CVMP assessment report Rapp: H. Jukes For endorsement: Rapporteur’s assessment report on the PSUR for the period 01.04.17 – 30.09.17



Bovela EMEA/V/C/003703

Rapp: F. Klein For endorsement: Rapporteur’s evaluation of the PSUR for the period 01.01.17 - 30.06.17



Coliprotec F4 EMEA/V/C/003797

Rapp: N. Garcia del Blanco For endorsement: Rapporteur’s assessment report on the PSUR for the period 01.04.17 – 30.09.17

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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Econor EMEA/V/C/000042

Rapp: H. Jukes For endorsement: Rapporteur’s assessment report on the PSUR for the period 01.10.16 – 30.09.17



Fortekor Plus EMEA/V/C/002804

Rapp: E. Vestergaard For endorsement: Rapporteur’s assessment report on the PSUR for the period 01.04.17 – 30.09.17



Eravac EMEA/V/C/004239

Rapp: C. Muñoz For endorsement: Rapporteur’s evaluation of the PSUR for the period 01.04.17 – 30.09.17



Eurican Herpes EMEA/V/C/000059

Rapp: N. Garcia del Blanco For endorsement: Rapporteur’s evaluation of the PSUR for the period 01.10.16 - 30.09.17



Proteq Flu EMEA/V/C/000073

Rapp: J.-C. Rouby For endorsement: Rapporteur’s evaluation of the PSUR for the period 01.10.16 - 30.09.17



Proteq Flu Te EMEA/V/C/000074

Rapp: J.-C. Rouby For endorsement: Rapporteur’s evaluation of the PSUR for the period 01.10.16 - 30.09.17

• 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: EU comments on JMAFF proposal for advancing the work on extraneous viruses in veterinary vaccines



For endorsement: EU comments on the revised concept paper proposing development of a guideline on safety evaluation of biotechnology-derived/biological products



For endorsement: EU comments on draft concept paper for a VICH guideline providing guidance on the establishment and running of a basic pharmacovigilance system

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

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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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 7.1

Scientific Advice Working Party (SAWP-V)

Information relating to SAWP 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 Working Group on the application of the 3Rs (J3RsWG)

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 •

For adoption: Revised list of substances considered as not falling within the scope of Regulation (EC) No 470/2009

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

Antimicrobial resistance

Information on certain topics discussed under section 8.3 cannot be released at the present time as it is deemed to be confidential

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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8.4 •

Pharmacovigilance No items

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 be commercially confidential •

No items

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 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: Verbal report from the CMDv chair on the meetings held in December 2017 and January 2018, draft minutes of the meeting held on 18-19 January 2018; draft agenda of meeting to be held on 15-16 February 2018

12. •

ORGANISATIONAL AND STRATEGIC MATTERS For information: Verbal report from the chair of the Strategic Planning Group (SPG) meeting to be held on 14 February 2018, draft agenda; draft minutes from the SPG meeting held on 8 November 2017



For information: Verbal update on the EMA working group on operational preparedness for veterinary medicines

13.

LEGISLATION

Information on certain topics discussed under section 13 cannot be released at the present time as it is deemed to be confidential 14. •

ANY OTHER BUSINESS For comments: Press release of the meeting

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

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ANNEX NEXT MEETINGS OF THE CVMP AND ITS WORKING PARTIES CVMP

ADVENT

AWP

ERAWP

EWP

IWP

PhVWP

QWP

SAWP

SWP

J3Rs WG

Feb 2018

13-15

Mar 2018

13-15

Apr 2018

17-19

May 2018

23-25*

June 2018

19-21

15

20-21

20-21

28-1

20-21

27-1

13

1-2

13 17

25

29-30

29-30 5-6

Committee for Medicinal Products for Veterinary Use EMA/CVMP/88236/2018

29-30 6-7

23 5-7

17-18

19

Page 11/11

Agenda - European Medicines Agency - Europa EU

Feb 9, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. •. Product. EMEA/V/C/004222/0000. New product for a musculo-skeletal disorder.

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