esubmission roadmap v2.0: Industry viewpoint

TOPRA Veterinary Medicines Symposium 2017 esubmission roadmap v2.0: Industry viewpoint Patrizia Oelker Boehringer Ingelheim Animal Health ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

Presentation objectives To review the vet-relevant components of the esubmission Roadmap v2.0 To identify progress made towards reduction of administrative burden To identify further opportunities To raise awareness of practical implications for industry of on-going IT development Relevant esubmission Roadmap components: 1. VNeeS 2. Common repository 3. Integrated submission portal 4. CESSP 5. SPOR

1. VNeeS New milestones for VNeeS mandatory use in national procedures (NP) Q3 2018 for new MAA Q1 2019 for all submissions This is in agreement with IFAH-Europe s position to allow sufficient time for smaller veterinary companies to accommodate to the new requirements

2. Common Repository

2. Common Repository Applicants/MAHs submit applications only once to EMA (via current Gateway/Web Client) No further submissions by other means to any MS Single & centralised archiving of submission packages for the NCA Network with remote access to dossiers - all submission types

3. Integrated submission portal One integrated portal with one single user registration for all procedure types Mandatory use in Q3 2019 Further reduction of administrative burden Strong plea that all NCAs accept CESP-only submissions well before Q3 2019

Preparing an MRP or DCP submission today Member State 1 2 3 4 5 6 7 8 9 n CESP can be used? x x x x x x x x CESP + signed paper copy of eaf? CESP + signed paper copy of CL? eaf may bear text snippet eaf must bear scanned signature Some documents in national language? x x x x x x x x x x x x Payment in advance? x x x Bank account provisioning? Other national req.? x x x x x

4. CESSP data sets CESSP: Common European Single Submission Portal Web user interface Application datasets generated online will replace eaf For new MAA and line extensions: 2018 For variations and renewals in a 2nd step 1st UAT in May 2017

4. CESSP some technicalities Need to convert CESSP output into a human readable file format, also archivable long-term Confirmation sought that VNeeS packages with CESSP output will be accepted by all NCAs for all procedures Having to manage different systems/processes increases complexity and in consequence administrative burden To what extent is IDMP compatibility of CESSP desirable for the veterinary sector?

5. Integration with SPOR What impact for companies?

5.1 OMS impact Will be integrated with eaf and CESSP After a transition period, current free text fields for MA applicant / MA Holder / manufacturers will be replaced by drop down lists. Pre-registration of Org. details in OMS by Industry ahead of submission will be needed Change will be validated by EMA team Check OMS before starting eaf compilation! Factor more time in case a change request to EMA must be filed Refer to EMA document on SPOR SLAs

5.2 RMS impact Already integrated with eaf Will be integrated with CESSP Similar to current process: Industry to request registration of new/updated terms before regulatory submission Change will be validated by EMA team Check RMS before starting eaf compilation Factor more time in case a change request to EMA must be filed Refer to EMA document on SPOR SLAs Refer to EMA explanatory document linked to each referentials list

5.3 SMS & PMS Management Systems for Substances and Products Integration of SMS with eaf and CESSP will require preregistration of substances in SMS IFAH-Europe s vision: single data entry in CESSP (i.e. PMS consumes product data from CESSP) However, discussions at the EMA working groups are largely dominated by Human Pharma concerns and needs (legal obligation in the EU to comply with ISO IDMP requirements)

5.3 SMS & PMS IFAH-Europe calls for simple and cost effective IT solutions for the veterinary domain to reduce administrative burdens ISO IDMP is not a requirement for the veterinary sector SMS & PMS implementation must be: appropriately adapted to AH considering size and requirements only to the extent necessary thereby contributing to the goal of the EU Commission proposal for a Regulation on VMPs* *2014/0257 (COD)

Concluding remarks 100% IFAH-Europe calls for: simple and cost-effective IT solutions, harmonisation of tools amongst various procedures (CP, MRP/DCP, NP). Goal of the EC proposal: reduce administrative burdens, >> increasing the availability of VMPs and stimulating competitiveness. 6% 13% 3% *Assessment of the Impact of the Revision of Veterinary Pharmaceutical Legislation, 11 July 2011

EU esubmission Roadmap v2.0 Thank you for your attention

Acronyms CESP: Common European Submission Platform CESSP: Common European Single Submission Platform CL: Cover Letter eaf: electronic Application Form IDMP: IDentification of Medicinal Products IFAH-Europe: International Federation for Animal Health-Europe OMS: Organisations Management System MAA: Marketing Authorisation Application NCA: National Competent Authority PMS: Products Management System RMS: Referentials Management System SLA: Service Level Agreement SMS: Substances Management System SPOR: Substances, Products, Organisations, Referentials UAT: User Acceptance Testing VNeeS: Veterinary Non-eCTD electronic Submission

Back up slides Link to the EMA esubmission website http://esubmission.ema.europa.eu/tiges/vetesub.htm Link to the esubmission Roadmap v2.0 http://esubmission.ema.europa.eu/tiges/cmbdocumentation.h tml

esubmission Roadmap v1.0 (reflecting final adopted version 1.0 dated 141107) draft esub Roadmap NCA & industry survey esub Roadmap Adoption Ongoing/optional Mandatory Use of ectd v.4 All submissions in CP (human) in ectd New MAA in DCP (human) in ectd Use of NeeS and ectd in DCP and MRP (human) All submissions in MRP (human) New MAA in DCP and MRP (human) in ectd All other MRP submissions (human) All submissions in CP, DCP and MRP (human) in ectd Use of VNeeS in CP, DCP and MRP (vet) New MAA in CP and DCP (vet) in VNeeS All other in CP and all MRP submissions (vet) All submissions in CP, DCP and MRP (vet) in VNeeS egateway (CP) (human and vet) CESP (human and vet) egateway (CP, human) Use of eaf in all procedures (human and vet) in CP in all other procedures Single submission portal - combined CESP/Gateway in CP (human) Single submission portal - combined CESP/Gateway in all other procedures (human and vet) eaf in all procedures (human and vet) Single Submission Portal with integration of eaf for all submissions (human and vet) NCA use of Common Repository for CP submissions (human) NCA use of Common Repository for all CP submissions (human) Use of PSUR Repository for CAPs and NAPs (human) Use of PSUR Repository for all CAPs and NAPs (human) 2013 2014 2015 2016 2017 2018 22

IDMP (IDentification of Medicinal Products) SPOR is used to implement ISO IDMP in the EU The ISO IDMP standards were developed in response to a worldwide demand for internationally harmonized specifications for medicinal products (authorized and investigational) In the EU, for Human Pharma: ISO IDMP is a legal requirement Pharmacovigilance Legislation, in particular EC Regulation 1235/2010, and Commission Implementing Regulation 520/2012 (= the IDMP Regulation ) ISO Standards should be implemented in other regions/ countries too (US, Canada, Switzerland, ) Key Goals: - standardise the information, - have interoperable systems, - enhance patient safety (PhV!)