HCWH Europe welcomes today’s European Parliament (EP) adoption of the ENVI Committee report on the European Commission (EC) regulation proposal of veterinary medicinal products. The report contains several positive amendments to the EC regulation proposal.
With this vote, the European Parliament has shown its willingness to tackle the growing problem of antimicrobial resistance.
“Antimicrobial resistance is a huge problem that needs to be tackled. Limiting antibiotic use in groups of animals to only clinically-ill animals and to individual animals that are identified as being at a high risk of contamination, to prevent further spread of the disease in the group, is an important step towards reducing antimicrobial resistance” - HCWH Europe Deputy Director, Grazia Cioci.
The EP has improved the marketing authorisation of veterinary medicines. Although the marketing authorisation of veterinary medicinal products has not been limited to a time period, but has been kept valid for an unlimited period of time, a re-examination is foreseen if risks to public health, animal health and the environment are detected and in cases where new scientific knowledge is available.
In addtion, the EP today also voted in favour of veterinary medicinal products being subject to an environmental risk assessment (ERA) (in accordance with annex II) in the authorization process. However, we regret that there is no longer the obligation for medicines that have already undergone an ERA and are considered potentially harmful for the environment to be reassessed.
This vote also provides for greater accessibility to veterinary medicines’ safety data as applicants must submit to the competent authority or the European Medicines Agency, on their request, safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if there are well founded reasons to believe that authorisation can result in an increased risk to the environment from the generic product as compared to the reference product. However, medicines that are already on the market are not covered by this rule, and we regret that there is no request for the Commission to establish a substance-based review system that would complete existing environmental risk assessments with missing necessary environmental data.
We now look forward to the Council's debate on this file hoping that they will be as progressive and ambitious as the EP on restricting the use of antimicrobial veterinary medicines on animals and in improving the authorisation process of veterinary medicines.
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