Using OMS data in eAF

(EMA SPOR webinar, 14 June 2018)

Content

1. About OMS
2. Using OMS in eAF/CESP
3. Submission of OMS Change Requests (CRs)
4. Key messages
5. OMS support & guidance
6. Download Webinar (PDF)

1.) About OMS

2.) Using OMS in eAF/CESP

3.) Submission of OMS Change Requests (CRs)

4.) Key messages to Using OMS data in eAF

Using OMS data in eAF in a nutshell:

• OMS dictionary (list of organisations with associated physical locations) can be used to support regulatory business processes
• OMS content is growing and data quality is expected to improve over time
• Business owner of the process using OMS data decides how/when to use it and mandates its use. OMS team will work closely with the business process owners
• eAF will not mandate the use of OMS data, free text will still be available
• CESP will mandate the use of OMS data in the form. Organisation data will have to be pre-registered in OMS and can be selected in CESP. This is not planned before Q3-2019 for Initial MA Applications
• Applicants are advised to familiarise themselves with the use of OMS data and with the process before the use of OMS data will be mandated
• Applicants and MAHs are responsible to register/update organisation data in OMS before regulatory submissions (e.g. Initial MAA, Var, Renewal)
• Submission of OMS Change Requests for Veterinary MAH & MAAs for NAPs starts from September 2018

5.) OMS support & guidance

Reference documents accessible from the SPOR portal

• OMS web user manual – guidance on OMS services, e.g. searching, exporting data, requesting CRs
• SPOR user registration manual (how to register for SPOR)
• SPOR affiliation template (to register the first industry super user)
• Change Request  (CR) Validation in OMS
• Organisation data quality standards in OMS
• SPOR SLAs (SLA are indicative and will be reviewed in future)

Training videos

OMS training videos available to view on the @emainfo channel

EMA Website

EMA corporate website also includes SPOR related information, documents and material from webinars.

EMA Account Management Portal

To create a new EMA account in order to obtain access to EMA systems (including SPOR). To request SPOR user role.

Account Management Portal.

EMA Service Desk Portal

Service requests, issues, requests for technical support shall be submitted through the Service Desk Portal.

6.) Download Webinar

Download Webinar (PDF)

Using OMS data in eAF EMA Webinar 14.6.2018 (210 downloads)