Safety
Reporting an adverse event or a quality defect
If an animal reacts badly to something we supplied, or a product does not perform as it should, we want to know within days rather than at the next order. This page says exactly how to tell us and what happens next.
What to report
- Any unfavourable reaction in a treated animal, whether or not you think the product caused it
- Lack of expected efficacy at the labelled dose
- Suspected residues in food-producing animals, or a withdrawal period that appears inadequate
- Accidental exposure of a person, including self-injection, splashes and ingestion
- Effects on non-target animals, including other species in the same household or herd
- Environmental effects
- Product quality defects: broken seals, particles in solution, discolouration, short fill, illegible batch coding
- Suspected falsified product
How to report
Email regulatory@sarvalokanimalhealth.com with “Adverse event” or “Quality defect” in the subject line. Include as much of the following as you have. An incomplete report sent today is more useful than a complete one sent next month.
- Product name, pack size, batch number and expiry date
- Our order reference, if you have it
- Species, breed, age, weight and number of animals affected
- Dose given, route, and how long the animal was treated
- What happened, when it started, how long it lasted and the outcome
- Any other products given at the same time
- Photographs, where there is something visible
- Your name, organisation and country, and whether you are a veterinarian, distributor or owner
What happens next
We acknowledge within two working days and give the report a reference. It goes to the manufacturer's pharmacovigilance function along with our own goods-in and storage records for that batch, so the investigation starts with the supply chain evidence attached rather than waiting on it.
If the report suggests a batch problem we check where else that batch went and contact those customers. If it suggests a labelling or dosing issue we raise it with the manufacturer for the technical sheet. You get the outcome in writing, including when the conclusion is that the product was not implicated.
Your own obligations
If you hold the marketing authorisation in your market, you have legal reporting duties to your own authority with defined timelines, and telling us does not satisfy them. Serious adverse events are commonly reportable within fifteen days. Check your national requirement, because the clock starts when you first hear about the event, not when the investigation finishes.
Common questions
Who do I report a veterinary adverse event to?
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Report it to us at regulatory@sarvalokanimalhealth.com and, separately, to your national authority if you hold the marketing authorisation. In the EU that means the competent authority and the EudraVigilance Veterinary system; in the UK, the VMD Suspected Adverse Event Scheme; in Australia, the APVMA. Our report to the manufacturer does not discharge your legal obligation as the registration holder.
Does an adverse event include a human exposure?
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Yes. Accidental self-injection, skin or eye exposure and ingestion by a handler are all reportable, and they matter more than they sound because several veterinary products cause serious harm in people. Seek medical advice first, then report.
What if the product simply did not work?
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That is lack of expected efficacy and it is reportable in the same way. It can point to a genuine product problem, a storage failure, a dosing error or emerging resistance. All four are worth knowing about.