Veterinary Pharmacovigilance in EU – an Insight into Databases, Scope and Access Pre-Requisites

Let’s learn in detail about each of these database(s) with respect to Veterinary vigilance

1. Eudravigilance:

EudraVigilance is the data-processing network and database for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area. Since Eudravigilance iscentralized system from where any MAH can access different other database hence this becomes the first pre-requisite for MAH to have account in EMA.

Let’s look into pre-requisites for Eudravigilance access:

A. Identify a person from organization who should be having account in EMA. Once it is identified below details must be submitted to EMA in order to get account created

B. User's first and last name, mail id and phone no, company name, postal code, Company cover letter.

Once Account has been created, user can request for veterinary specific access. To get an access to Eudravgilance Vet below has to be ready with MAH.

• The organization is registered in the Organization Management System (OMS) as part of maintaining pharmacovigilance documentation
• Request role of EV VET MAH Responsible or EV VET NCA Responsible in the EMA Account Management portal by following steps mentioned above

Below is the overview of registration process for Eudravigilance veterinary for easy read

Reference: eudravigilance-veterinary-registration-manual_en.pdf

2. SPOR:

The SPOR are databases and services to manage the lists of controlled terminologies, which will be supplied in the electronic submission of veterinary medicinal product information into the UPD. What are the veterinary specific data available in SPOR? All Veterinary MAH need to have this account in order to add their organization details (OMS) and referential details (RMS). To get an access to SPOR, user must have active EMA account. By default, user will have SPOR unaffiliated user role. This role will enable the user to create their organization in this database.

3. Union Pharmacovigilance Database:

The Union Pharmacovigilance Database stores and makes available information on suspected adverse events for all veterinary medicinal products authorized in the Union.

Reference: 131487_f215e50d-4231-48f2-b00d-a3e475b4a7b0 (5).pdf

4. Union product database:

The Union Product Database serves as a single source of information on all authorized veterinary medicines and their availability in EU and EEA Member States. Scope: Regulation (EU) 2019/6 mandates competent authorities (national competent authorities and the European Medicines Agency on behalf of the European Commission) to electronically submit and maintain information on all medicinal products for veterinary use into the UPD. The Regulation is applicable from January 2022 after a 3-year implementation period. What UPD contains or type of data stored: For marketing authorization holders, the Union Product Database provides self- service access for specific regulatory activities, including the management of variations that do not require assessment. It will also enable and simplify several regulatory procedures.

Reference: 131487_f215e50d-4231-48f2-b00d-a3e475b4a7b0 (5).pdf

Pre-Requisite:

• Eudra SSO (Single Sign-On) username and password
• Active EMA account to raise request for user Eudra SSO username and password
• Correct Organisation details added in OMS.