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Database Support

Substance, Product, Organisation and Referential (SPOR)

What is it?

The European Medicines Agency (EMA) is implementing the International Organisation for Standardisation (ISO) Identification of Medicinal Products (IDMP) standards for the identification of medicinal products, based on the four domains of master data in pharmaceutical regulatory processes:

  • Substance Management Service (SMS)
  • Product Management Service (PMS)
  • Organisations Management Service (OMS)
  • Referentials Management Service (RMS)

The SMS and PMS are not yet fully implemented by the EMA.

Registration with OMS is mandatory for sponsor’s performing clinical trials and for marketing authorisation holders of medicinal products in the European Economic Area (EEA).

RMS relates to referential data and is the responsibility of the EMA.

How we can help

Kinapse can assist you with the registration of Super Users and subsequently the management of your organisation within the OMS.


What is it?

EudraVigilance is the EMA’s database for managing and analysing information on suspected adverse reactions to medicinal products that have been authorised or being studied in clinical trials in the European Economic Area (EEA).

During a clinical trial, the sponsor is legally required to submit Suspected Unexpected Serious Adverse Reactions (SUSAR) to EudraVigilance within 7 or 15 days of occurrence, depending on their seriousness.

For marketed medicinal products the marketing authorisation holder is legally required to submit all adverse drug reactions that are suspected to be related to their product to EudraVigilance within 15 or 90 days of occurrence, depending on their seriousness.

How we can help

Kinapse can assist you in registering for your organisation and individual users within EudraVigilance.

We will also submit SUSARs and adverse drug reactions as part of our case processing service.

Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)

What is it?

It is strongly advised that the investigational medicinal product is entered within xEVMPD prior to completion of a clinical trial application for that product. The xEVMPD code for an investigational product is typically included within the Clinical Trial Application

Registration to EudraVigilance is a prerequisite in order to be able to submit investigational medicinal product information into xEVMPD.

As such, sponsors must therefore be registered with the EMA’s EudraVigilance database prior to starting a clinical trial within the EEA.

How we can help

Sponsors may delegate the sending of medicinal product information to clinical research organisations (CROs) or IT vendors. CROs and IT vendors may be registered by a marketing authorisation holder, applicant, commercial or non-commercial sponsor as a third party service provider acting on behalf of these organisations by providing services related to EudraVigilance.

Kinapse can also support you in the creation, submission and maintenance of xEVMPD product records. Our dedicated xEVMPD team has extensive experience, having reviewed more than 1 million product records.

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Post Authorisation Pharmacovigilance

  • Pharmacovigilance System Management
  • Risk Management Plans (RMP)
  • Safety Report Writing (PSUR/PBRER, PADER)
  • Literature Services
  • Signal Detection
  • Adverse Event Processing and Expedited Submissions
  • Independent Quality Control
  • Safety Call Centre

Clinical Trial Drug Safety

  • Case Processing and Submissions
  • Safety Data Report Writing (DSUR)