New Regulation 2019/6, 2019/5 and 2019/4 on veterinary medicines effective

Various other EU and national legislation effective from 28JAN2022as well

Did you know, that EU Regulations 2019/4, 2019/5 and 2019/6 are effective from 28JAN2022, but various other European implementing and delegating acts also become effective ? Did you know, that also many EU countries had to modify or even completely exchanged current regulations with new legal acts, also effective from 28JAN2022?

Today, 28JAN2022 is the birthdate of many new legal requirements applicable for essentially anyone having to do with veterinary medicinal products (VMPs). On top of the European Regulations 2019/4, 2019/5 and 2019/6, various delegating and implementing acts come into force.  A major step forward it the pan-European Union Product Database with all VMPs registered across the EU. GMP and GDP will be obligatory for production and logistics providing more safety. The changes impact basically anything related to Veterinary medicines, including the relationship to human medicines, but also in relation to third countries including the UK. The impact is not limited to EU legislation but has triggered the change in many EU member states. Our home country, Germany, took this change as the step to have a fully separated legislation from (human) medicines for VMPs. The lack of legislation on medical devices sustains. The new legislation had the objective to trigger innovation and help to harmonise the EU market. There is some doubts for certain areas, if this will be achieved, but as in many cases, this is also a matter of perspective. In a recent poll by the participants of next weeks webinar on the new regulation, 60 % consider that time and cost to market will rather increase. For all parties involved, this is a major step, for vets prescribing, animal owners, the scientific community, the animal health industry, but also the competent authorities: we all have to accomodate to the new legal requirements, apply it and use it to achieve the best out of it, including utilising the new options for innovation.
Are you interested in more news: follow KLIFOVET and Argenta on LinkedIn to make sure that you do not miss important information. Join us in our upcoming webinar and workshop as part of the animal Animal Health Summit on Animal Health Nutrition and Technology Innovation EU in London on 21st to 23rd of February 2022. Please, watch out for our news on further events.