Austrian Agency for Health and Food Safety www.ages.at

Mag. Beate Gasser LCM/REGA

AGES Gespräch Authorisation of Veterinary Medicinal Products (VMPs): an Update

Vienna, 08.11.2016

News from veterinary procedures - pros & cons

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•News for different types of procedures for MR/DC products

•Electronic submission

•Where can I find useful infos and contacts?

Agenda

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•Best Practice Guide (BPG) „GUIDANCE for The Processing of Generic Applications Through MRP / DCP”:

- Updated to clarify that doubts about the Reference Medicinal Product can’t be subject to the MR/DC procedure or a reason for an Art. 33 Referral. These issues have to be handled in an Art. 34 or 35 Referral.

- Clarification that Hybrid Art. 13(3) may also apply for a change in the withdrawal period.

New Applications

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•CMDv Position Paper on Agreeing Product Name During the Decentralised Procedure:

http://www.hma.eu/162.html

•Clock stop is used to agree on a product name. Change after clock stop without justified grounds will be refused. Variation will have to be submitted

afterwards

New Applications

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•Please consider CMDv standard validation checklist when preparing new applications:

http://www.hma.eu/161.html

•DDPS: http://www.hma.eu/150.html

- Following a 12 month pilot phase and based upon positive feedback from industry and agencies, the CMDv has agreed to continue the use of the DDPS declaration form on an indefinite basis. CMDv has agreed to extend the possibility to use the DDPS declaration in all application procedures (Decentralised, Mutual Recognition and National) for new marketing authorisations (but not variations), where use of such a declaration is appropriate.

New Applications

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•CMDv clarification on use of pictograms:

http://www.hma.eu/166.html

CMDv agrees that pictograms of animal species from an approved catalogue can be used to replace the wording of the target species on small immediate labels, ampoules and blisters. The CMDv has endorsed the target species pictograms as published by IFAH-Europe for use only as described within this CMDv clarification paper.

Guidance paper of QRD group will be published soon.

Pictograms

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•Variations

•Renewals

•Purely national procedures

Life Cycle Applications

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•Name/address change of MAH: Pilot started to reduce administrative burden: Only necessary to submit to the RMS and the CMS concerned.

•Change of the product name: Different names for different MS proposed can be submitted as a

single IB A.2. Clock stop will be used to come to reach an agreement and come to a single outcome.

•Part II harmonisation for national products via Worksharing is being explored.

Variations

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•Please also consider CMDv validation checklist

•Will be new in Best Practice Guide of CMDv soon: Administrative Renewal for new CMS after RUP possible

- reduced timetable and documentation

- http://www.hma.eu/164.html

BPG Handling renewals in the Mutual Recognition and Decentralised Procedure

Renewal

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•For MR/DC products the transfer of a marketing authorisation is a national procedure only (specifically excluded in Variation Regulation)

•Please note the CMDv Recommendations for Management of Post-Authorisation Procedures and Pharmacovigilance Activities after Partial Marketing Authorisation Transfer at National Level Following Mutual Recognition or Decentralized Procedure (so-called Partial MAH Transfer) http://www.hma.eu/160.html

Purely national procedures

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•Distributor/local representative: According to current CMDv practice national procedure only. Please include in next variation translation if possible, otherwise contact Ms. Martha Weiss or Ms. Birgit Haider

•Harmonisation of translations with DE and/or BE: Please harmonise during the next variation if possible, otherwise submit a national variation C.II.z as IB

Purely national procedures

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•Electronic submission mandatory in AT (Electronic Submission Regulation)

•CESP is preferred for all dossiers, CD/DVD possible

•Translations should be submitted via the eService portal of the BASG http://www.basg.gv.at/en/eservices/

•eAF mandatory for all kinds of submissions. Please sign eAF (scan sufficient)

eSubmission

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•VNeeS mandatory for all kinds of submissions in MRP and DCP (+lifecycle) from 01.01.2017

eSubmission

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•Please take note of the Guideline on eSubmissions for Veterinary products and the VNeeS checker on the Tiges Vet eSubmission website :

- http://esubmission.ema.europa.eu/tiges/vetesub.htm

eSubmission

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•http://www.hma.eu/156.html

CMDv Website

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CMDv Best Practice Guides etc.

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•General Info on Licensing System:

- E.g. Format and number of copies, Adresses for delivery and other contact points, Additional national requirements, Marketing Authorisation Transfer

•Applications:

- E.g. User Guide eAF, validation checklists, BPGs for different kinds of applications (generics, informed consent), link to national fees, ASMF procedure

•Marketing Authorisation Procedures:

- BPGs for MRP, RUP and DCP, Clarification Paper on Agreeing the product name during DCP

CMDv Best Practice Guides etc.

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•Variations:

- BPGs for different types, decisions on classification of unforeseen variations, Q&As

•Renewals:

- BPG, validation checklist

•Referrals:

- Standard Operating Procedure, Actions after Art. 33, Recommendation for MRP after Art. 34

•SPC, Labelling and Package Leaflet:

- Annotated QRD template, Clarification on use of pictograms

CMDv Best Practice Guides etc.

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•Active Substance Master File (ASMF):

- CMDv BPG Active Substance Master File (ASMF) in the Mutual Recognition and Decentralised Procedures, all other documents link to CMDh or EMA-Website better to use

link to ASMF Working Group-Website under “Applications”

•Miscellaneous:

- E.g. Changing the RMS

CMDv Best Practice Guides etc.

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CMDv website: Other information

Latest decisions of CMDv

Clock Start dates for MRP/RUP

and Second Stage DCP

DDPS declaration form and instructions, BPG PSUR

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Questions???

Thank you!