Mag. Dr. Peter Platzer

AGES Medizinmarktaufsicht, BASG

Marketing Authorisation of Medicinal Products

31. August 2017

Agenda

• Tasks of the Institute LCM

• AT as RMS

• eSubmission Roadmap AT

• Brexit Considerations

3

LCM – WHERE are we ?

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Centralised procedure Marketing authorisation (MA) in the whole EU - human

Centralised procedure Marketing authorisation (MA) in the whole EU - veterinary

Mutual Recognition and Decentralised Procedure MA in more than one Member State (MS)

[Reference Member State vs. Concerned Member State] National procedure MA in only one MS

Possible marketing authorisation routes in the EU LCM

√

√

x

√

LCM – WHAT do we do ?

• We administrate and coordinate procedures to gain Marketing Authorisations for human and veterinary Medicinal Products in MRP/DCP/national procedures and for veterinary Medicinal Products in CP procedures

• We provide Assessment Reports covering Quality and Medical assessments

• We handle Lifecycle of Medicinal Products • We actively participate in numerous international

and national Working Parties

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New marketing authorisations vs. withdrawals

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Number of Variations remains at high level

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9.182 Some figures about Medicinal Products authorised nationally in AT

Medicinal Products are authorised for veterinary use in AT by 31.12.2016

3.916

Medicinal Products that have been withdrawn in 2016 438 1.418

Medicinal Products are registered in AT by 31.12.2016

Medicinal Products are authorised for human use in AT by 31.12.2016

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121 … and some more figures in LCM

employees with academic background

77%

colleagues are on maternity leave currently 5% 74%

female employees

colleagues are working in LCM

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AT in the role as RMS

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High scientific quality / Competence Direct and individual contact to case managers (and

assessors) Rapid finalisation of Procedures and fast access to market Reliability in timely manner / flexibility Reliability of scientific assessment / Lasting decisions for

European Procedures Pragmatic decisions / Well-considered questions Active participation within EU network

What does Industrie expect ?

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Case Management to optimize communication

Case Manager

MEA internal COM

MU

NIC

ATIO

N

• DCPs, MRPs and Lifecycle (AT=RMS) contact details: http://www.basg.gv.at/en/about-us/contact-us/

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Timely initiation of the clock-stop period in consultation with the applicant.

Different options (based on the issues raised by the RMS and the CMS) in consultation with the Case Manager: • Submission of draft responses for pre-assessment to the RMS only. • Submission of final responses to the RMS and the CMS.

Clock-Stop Phase – company‘s choice

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Early closure of a procedure, if procurable. • If the RMS and all CMS have reached consensus and agree to the

authorisation of the medicinal product.

Fast national implementation, if applicable. • Following the submission of high quality national translations of

SmPC, PL and Labelling or • Conditional approval – Marketing authorisation without national

translations.

We try to reduce Approval Phase

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Slots for DCPs are visible and can be booked http://www.basg.gv.at/arzneimittel/zulassungsverfahren/oesterreich-als-rms/dcpmrprup-slots

0

10

20

30

40

50

60

70

80

90

20112012

20132014

20152016

5 2

11 11

0

10

44 47

30

90

63

81

MRPs

DCPs

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Started procedures within the last years

0

50

100

150

200

250

300

350

NL DE UK PT DK SE AT ES CZ HU FI MT PL EE FR NO SK IS IT LV SI IE HR RO BE BG LT CY EL LI LU

Started DCPs/MRPs in 2016

MRP DCP

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AT as RMS within best quarter in EU

Source: CMDh

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Domination of Generics

2%

69%

13%

7%

9%

AT=RMS legal basis of procedures (finalised in 2016)

Full dossier application

Generic application

Hybrid application

Traditional Herbal application

Well-established use application

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CEP Assessment – AT is #1 AT

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AT acts successful as RMS for herbal medicinal products

CTS 7.3.2017

AT eSubmission Roadmap http://www.basg.gv.at/en/eservices/ectdvnees/

eAF mandatory for • All national applications from 01/2016 eCTD mandatory for • National new applications from 07/2018 • National lifecycle applications from 01/2019

VNeeS mandatory for • National new applications 07/2018 • National lifecycle applications from 01/2019

eCTD – current situation

• Appr. 75% of new national applications already correspond to eCTD format

• Appr. 40% of national variation applications already correspond to eCTD format

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Brexit Considerations

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Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human use within the European Union.

In particular, the CMDh expects marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.

Brexit Considerations

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10. What if my Reference Member State (RMS) for a Mutual Recognition (MRP) or Decentralised Procedure (DCP) is the UK?

According to Directive 2001/83/EC the evaluating agency (RMS) must be established in a member state of the Union. Through the EEA Agreement this is extended to include also Norway, Iceland and Liechtenstein.

For national authorised medicinal products via MRP/DCP the marketing authorisation holder in the RMS UK will therefore need to change the task of the RMS to an agency of a member state of the Union (EEA). The procedure and the prerequisites to switch the RMS for an authorised medicinal product for human use is outlined in the CMDh procedural advice on changing the RMS.

Brexit Considerations

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MS have furthermore agreed upon that a justified reason is “RMS has triggered Article 50 of the Treaty on European Union”. In that connection agreement has also been reached by MS that a switch back to that MS who has triggered Article 50 will also be allowed if there will be an exemption agreed as a result of the negotiations between that RMS and the EU.

Brexit Considerations

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Currently approximately 1000 medicinal products authorised in AT, where UK is RMS and AT is CMS

2/3 human and 1/3 veterinary medicinal products

What do we do? We consider RMS transfers and enhancement of RMS activities

for new applications We develope business cases for various scenarios We discuss companies‘ strategies / needs within „pipeline“

meetings in order to plan ressources

Brexit Considerations - AT

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