Pharmacovigilance is a set of activities related to the collection, detection, assessment, understanding, preventing and responding to the adverse reactions to medicines as well as other problems related to their use.

Veterinary pharmacovigilance is a monitoring system for ensuring the safety of veterinary medicinal products, including vaccines, used for the prophylaxis, diagnosis or treatment of disease in animals. The task of veterinary pharmacovigilance is to ensure the following:

• safe use of veterinary medicinal products in animals;
• safety of animal-derived food;
• safety for people who get into contact with veterinary medicinal products;
• safety for the environment.

Reporting on suspected adverse effects directly contributes to the safety of medicinal products. Based on collected information which are to be analyzed and assessed, certain regulatory measures may be taken in order to protect public health and animal health, as defined by the Law on Medicines.

Adverse reaction reports in veterinary medicine may relate to one of the following:

• adverse reaction in treated animal following recommended use of the medicinal product;
• adverse reaction in treated animal following off-label use;
• lack of expected efficacy;
• adverse reaction in humans following exposure to a veterinary medicinal product;
• violations of residue limits;
• impact on the environment.

The field of veterinary pharmacovigilance is regulated by the following:

– Law on medicines,

– Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.

CInMED and the marketing authorisation holder are obliged to collect and assess suspected adverse reaction reports and exchange obtained data.

Veterinary and healthcare professionals are obliged to report any suspected adverse reaction to a veterinary medicinal product to the marketing authorisation holder.

Adverse reaction to a veterinary medicinal product means a harmful and unintended reaction which occurs at doses normally used in animals for the prophylaxis, diagnosis, treatment of disease, or to restore, correct or modify physiological function.

Unexpected adverse reaction means an adverse reaction, the nature, severity, or outcome of which is not consistent with the Summary of Product Characteristics.

Serious adverse reaction to a veterinary medicinal product means any adverse reaction which results in death, is life-threatening, can cause incapacitation, congenital anomalies, or result in permanent or prolonged symptoms in the animals treated.

Adverse reaction to the veterinary medicinal production in humans means noxious unintended reaction which occurs in humans following the exposure to the veterinary medicinal product.

Off-label use of a veterinary medicinal product means the use of a medicinal product that is not in accordance with the approved summary of the product characteristics, including misuse and abuse of medicinal product.

And healthcare professionals are required to report suspected serious, or unexpected adverse reaction to a veterinary medicinal product in animals or humans, both to marketing authorisation holder and CInMED.

Suspected serious, or unexpected adverse reaction report may be submitted to CInMED directly, or through the marketing authorisation holder, i.e., wholesale authorisation holder for a veterinary medicinal product in Montenegro, using the Adverse reaction reporting form.

 

How to report adverse reactions to medicines

Veterinary and healthcare professionals may report suspected adverse reaction by completing the Adverse reaction reporting form (updated on 01.09.2022., document in Montenegrin), taking into account Notes important for completing the form (document in Montenegrin).

Personal data in the report will be used for safe use of medicinal products monitoring only and treatedin the strictest confidence, unless we are given permission to send your name and address to the company concerned, if further information requested.

The reporting of adverse reactions ensures continuous monitoring of benefits and risks of veterinary medicinal products on the market and thus contributes to their safe use.

Based on available information an assessment of the causal relationship between the administration of the medicinal product and the reported reaction is made.