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Parliamentary questions
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3 February 2022
Question for written answer  E-000474/2022
to the Commission
Rule 138
Joanna Kopcińska (ECR)
 Answer in writing 
 Subject: Adverse event reporting (AER) to EudraVigilance during the Covid-19 pandemic

Revised legislation on veterinary medicinal products has been in force in the EU since 28 January 2022. However, the impact of the pandemic has been unprecedented, so a new legal interpretation of the provisions adopted in 2019 is now required.

In accordance with Article 49 of Regulation (EC) No 726/2004 and Article 75(2) of Directive 2001/82/EC, the responsible entities are required to report electronically to the EudraVigilance Veterinary database all serious suspected adverse reactions within 15 days of learning of them.

In addition, in information provided to interested parties the EMA/HMA noted on 30 September 2021 that during the ongoing pandemic there was a risk that labour potential in industry could be reduced due to high absence levels and shortages of workers. This forced companies to activate their business continuity plans and set priorities for their activities. Therefore, where responsible entities, for legitimate reasons owing to the pandemic, cannot continue their standard reporting operations, they should prioritise their reporting obligations.

What action does the Commission intend to take to monitor the situation where there is the possibility for scaled-back AER to the EudraVigilance Veterinary system, which, in the long term, may lead to a distorted assessment of the real situation and, consequently, to a weakening of specific action, including action taken to tackle antimicrobial resistance?

Original language of question: PL
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