Why is it important to report suspected side effects?
To ensure that veterinary medicinal products are safe and effective, their approval is made after thorough pharmacological and toxicological investigations, although only a limited number of animals may be used during the studies leading to approval. Adverse reactions, which occur rarely or occur specifically in specific breeds or groups of animals, may only become known during their widespread use in veterinary practice after authorisation. For this reason, it is important that all adverse reactions are reported to the EOF so that the benefit/risk of the product can be continuously assessed.
What should be declared?
It is important to report the following types of side effects:
- adverse reaction, which causes death.
- adverse reaction, which causes significant prolonged or permanent symptoms
- unexpected side effect, which is not mentioned on the label or package leaflet.
- adverse reaction from a veterinary drug that occurs in humans.
- adverse reaction, which is observed after using the drug other than as prescribed.
- absence of expected efficacy of the veterinary medicinal product (possible indication of development of resistance).
- problem related to waiting time.
- possible environmental problems
- known side effect (which is mentioned in the package leaflet), which is serious or appears to be increasing in frequency and/or severity.
Submit via email – Print the Yellow Card and email it to vetpharmacovigilance at eof dot gr
Legislative basis
Pursuant to Veterinary Regulation 2019/6 (EU) and Articles 76-78 & 81, the competent authority (EOF) "shall register in the pharmacovigilance database of the European Medicines Agency (EMA) all suspected adverse events reported to them which occurred in the territory of their Member State, within 30 days of receipt of the suspected adverse event report and, respectively, marketing authorisation holders shall register in the EMA pharmacovigilance database all suspected adverse events reported to them which occurred within the Union or in a third country or have been published in the scientific literature in relation to their authorised veterinary medicinal products, without delay and at the latest within 30 days of receipt of the suspected adverse event report."
How are suspected adverse reactions reported?
Veterinarians, other healthcare professionals and individuals (licensed holders of a veterinary medicinal product store, pet owners, breeders of animals producing products) must report serious or not, expected or unexpected adverse reactions that may be related to the use of veterinary medicinal products in animals and humans, either directly to the competent authority (EOF) or to the Marketing Authorization Holder.
The declaration to the EOF should preferably be made using the European declaration form. yellow card for veterinarians. It is important to report as much detail as possible. If laboratory information, necropsy reports, photographs or other relevant information are available, they should be included in the report and possible alternative diagnoses will be considered.
The forms are sent by post or digitally by email to: National Medicines Organization (EOF) for the attention of the Veterinary Department, at vetpharmacovigilance@eof.gr.
BY PARTICIPATING IN THE ADVERSE REACTION REPORTING SYSTEM, YOU WILL CONTRIBUTE TO BETTER KNOWLEDGE OF VETERINARY MEDICINES,
FOR THE BENEFIT OF ANIMALS, THE PUBLIC AND YOUR COLLEAGUES
IN THE FIELD OF VETERINARY HEALTH.
COMPETENT AUTHORITY:
National Medicines Organization (EOF)
Veterinary Department
284 Mesogeion, Cholargos 155 62
TEL.: 213 2040213
E-mail : vetpharmacovigilance@eof.gr
