Latest Regulatory News


Regulatory Flexibility for Veterinary Medicines during COVID-19 Pandemic

The European Commission, EMA and the Coordination Group for Mutual Recognition and Decentralised Procedure (Veterinary) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in order to address some of the constraints posed by the COVID-19 pandemic.

According to the jointly developed question-and-answer (Q&A) document, regulatory rules for veterinary medicines should be applied with greater flexibility in the context of COVID-19 when necessary to mitigate the risk of supply disruptions caused by the pandemic. The guidance aims to ensure that high-quality, safe and effective veterinary medicines that are essential for protecting public and animal health continue to be available during the public health crisis.

The Q&A document sets out areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders in the veterinary sector may be faced with in the context of the pandemic. These measures cover different areas of regulation, including:

  • marketing authorisation procedures;
  • safety monitoring; and
  • inspections of manufacturing facilities and good manufacturing practice (GMP) for veterinary medicines.

The Q&A document was also endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership for urgent and coordinated action on possible shortages within the EU during this pandemic.

The Q&A document will be continuously updated. Veterinary stakeholders are advised to visit this page for regulatory information on the impact of the COVID-19 pandemic on veterinary medicines.

 

Latest Regulatory News

Apr-2021

Crop Protection > News

October 2020 European university publishes results on sensitivity differences in amphibians following fungicide exposure

  For the assessment of safety of crop protection products and aquatic amphibian exposure, most ecotoxicological studies concentrate on testing tadpoles in stage 25 (Gosner...

Read More

Mar-2021

Chemicals and REACH > News

EU & Nanomaterials

A survey of citizens in Austria, Bulgaria, Finland, France and Poland was published at the end of 2020 which concluded that in general, EU citizens...

Read More

Contact

LKC Switzerland Ltd
Hauptstrasse 10
P.O. Box 167
4414 Füllinsdorf
Switzerland

Phone: +41 (0) 61 906 8500
Fax: +41 (0) 61 906 8509
LKC@lkc-ltd.com

Information

Registration Number: CHE-113.597.134

Upcoming Events

2007-2021 © Copyright LKC Switzerland Ltd

Sign Up for Newsletter

x