INTCF-AEMPS Agreement 2026: What Changes in Veterinary Pharmacovigilance

Key data

The veterinary pharmaceutical sector and healthcare professionals working with animal medicines have a new active surveillance framework from September 2026. The INTCF —which manages the Toxicological Information Service, the national poison control reference centre— and the AEMPS have formalized a data exchange agreement that connects for the first time the toxicological cases of the SIT with the AEMPS veterinary pharmacovigilance database. The Resolution of 28 September 2026 publishes the text of the agreement, effective from 16 September 2026.

What does this regulation establish?

The agreement establishes a bidirectional flow of information between two bodies that until now operated with independent databases:

The ATC-VET coding (anatomical, therapeutic and chemical classification system for veterinary medicines) is the international standard that allows data comparison between countries and systems. By incorporating it into SIT reports, Spain improves the traceability and comparability of its animal medicine safety data at European scale.

The agreement also establishes a joint monitoring committee between both institutions, responsible for overseeing the execution of the agreement and resolving incidents in information exchange.

Regarding data protection, the text is explicit: the exchanged data will not identify natural persons, complying with the GDPR and LOPDGDD. This means that information flows in aggregated or anonymized form, without being able to trace individual cases of patients or animal owners.

Economic and operational impact

This agreement does not generate direct costs for private companies nor establish new fees. Its impact is mainly operational and regulatory, with indirect consequences for the veterinary pharmaceutical sector:

• Greater detection of risk signals: By crossing SIT data with pharmacovigilance data, the AEMPS will have more complete information to detect safety problems with veterinary medicines. This may result in technical sheet reviews, use restrictions or market withdrawals.
• Pressure on reporting quality: Veterinary pharmaceutical laboratories must ensure that their pharmacovigilance systems are aligned with the ATC-VET coding that the SIT will now also use. Poorly coded reporting can distort the safety signal.
• Human medicines used in animals (off-label use): The agreement expressly covers cases of human medicines administered to animals. This highlights a common practice in veterinary clinics that until now had little visibility in pharmacovigilance systems.
• Strengthening health and safety: The stated objective is to improve risk detection and strengthen the safety of people and animals, which may translate into greater regulatory scrutiny of products with toxicity signals.

Who does it affect?

• Pharmaceutical laboratories with veterinary medicines authorized in Spain: Greater exposure to safety signals detected by SIT-AEMPS data crossing.
• Clinical veterinarians: Their reports of adverse reactions and consultations to the SIT will directly feed the crossed system.
• Healthcare professionals (doctors, nurses, pharmacists): When they treat human poisonings from veterinary medicines or human medicines administered to animals, their consultations to the SIT will be registered in the new system.
• Citizens who contact the SIT: Animal owners or people accidentally exposed to veterinary medicines who call the poison control centre.
• Pharmacovigilance managers in sector companies: They must review their coding and reporting procedures to align with the ATC-VET standards that now connect both systems.

Practical example

A veterinarian at a small animal clinic administers a veterinary antiparasitic to a dog. The owner, when handling the product, suffers accidental exposure and calls the Toxicological Information Service (SIT). Until now, that consultation was recorded only in the INTCF database, with no connection to the AEMPS pharmacovigilance system.

With the new agreement, that case —anonymized and coded with ATC-VET— is crossed with the AEMPS veterinary pharmacovigilance database. If the same active ingredient accumulates a significant number of similar consultations, the AEMPS can detect a risk signal and act: request additional information from the marketing authorization holder laboratory, review the package insert or, in serious cases, restrict the use of the product. The laboratory holding the marketing authorization for that medicine may receive a request for information or see the technical sheet of its product modified as a direct result of this data crossing.

What should companies do now?

1. Review pharmacovigilance procedures: Laboratories with authorized veterinary medicines must verify that their reporting systems correctly use ATC-VET coding, as it is the standard that will connect SIT data with the AEMPS database.
2. Update off-label use protocols: Veterinary clinics that use human medicines in animals must properly document these cases and ensure that adverse reactions are reported to the Spanish Veterinary Pharmacovigilance System.
3. Train staff in reporting suspected adverse reactions: Both veterinarians and healthcare professionals must know the reporting channels to the SIT and AEMPS, as their communications now have greater regulatory impact.
4. Monitor AEMPS safety signals: Pharmacovigilance managers must be alert to possible AEMPS communications resulting from data crossing, which may require response within strict regulatory timeframes.
5. Verify data protection compliance: Although the agreement guarantees that exchanged data does not identify natural persons, companies managing pharmacovigilance data must review their own anonymization processes to comply with GDPR and LOPDGDD.

Official source

Consult complete regulation in official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-20699