Key data
| Regulation | Resolution of July 24, 2026, from the AEMPS, publishing the Agreement with the Valencian Generalitat for sending to FEDRA notifications of suspected adverse reactions to human medicinal products |
|---|---|
| BOE Publication | August 17, 2026 |
| Entry into force | July 22, 2026 |
| Affected parties | Valencian regional health authorities and notifying healthcare professionals |
| Category | Regulatory Changes |
| Year | 2026 |
| Systems involved | SIA-ABUCASIS (Valencian Community) and FEDRA database (AEMPS) |
| Communication protocol | REST API with HTTPS |
| Maximum batch size | 100 notifications per submission |
Healthcare professionals and public health authorities in the Valencian Community have had since July 22, 2026 a binding technical and legal framework for reporting suspected adverse reactions to human medicinal products. The Resolution of July 24, 2026 from the AEMPS publishes the agreement that formalizes this integration and establishes specific deadlines, responsibilities, and technical requirements for both parties.
This is not a recommendation: it is an agreement with specific obligations, maximum deadlines, and an incident management protocol that directly affects Valencian health information systems and the professionals who report adverse effects.
What does this regulation establish?
The agreement regulates the technical integration and operational obligations between two health information systems:
| Element | Detail |
|---|---|
| Regional system | SIA-ABUCASIS (Valencian Community) |
| National database | FEDRA (AEMPS) |
| Integration protocol | REST API with HTTPS encryption |
| Serious cases deadline | Maximum 10 calendar days from receipt |
| Non-serious cases deadline | Maximum 80 calendar days from receipt |
| Maximum batch size | 100 notifications per submission |
| Failure management | Automatic retries in case of submission failure |
| Incident management | Specific protocol included in the agreement |
| AEMPS responsibility | Administration and security of the FEDRA database |
| Generalitat responsibility | Correct implementation of the API on its end |
The objective of the agreement is to strengthen the Spanish pharmacovigilance network and improve early detection of adverse effects of medicinal products in human use, integrating regional notification flows into the national system in an automated and traceable manner.
Economic and operational impact
This agreement does not generate direct costs for private companies or individual healthcare professionals in terms of fees or economic sanctions published in the regulation. Its impact is fundamentally operational and technical compliance for the Valencian health administration.
The main operational impacts are:
- Technical adaptation of the SIA-ABUCASIS system: the Valencian Generalitat assumes responsibility for correctly implementing the REST API on its end. This may involve software development, integration testing, and continuous maintenance of the connector.
- Deadline management: pharmacovigilance teams must ensure that internal notification flows allow compliance with the 10 and 80 calendar day deadlines. Any delay in internal processes can result in non-compliance with the agreement.
- Incident protocol: the agreement includes a specific incident management protocol, which requires having human and technical resources for its monitoring and resolution.
- Automatic retries: the system contemplates automatic retries in case of submission failures, which requires active monitoring to detect persistent errors that are not resolved automatically.
Who does it affect?
- Conselleria de Sanitat Universal i Salut Pública of the Valencian Community: as responsible for the technical implementation of the API in the SIA-ABUCASIS system.
- Valencian regional pharmacovigilance teams: responsible for ensuring compliance with notification deadlines (10 days for serious cases, 80 for non-serious).
- Healthcare professionals notifying in the Valencian Community: doctors, pharmacists, and nurses who detect and report suspected adverse reactions to human medicinal products.
- AEMPS (Spanish Agency for Medicines and Health Products): as administrator and responsible for security of the FEDRA database.
- Health information system managers: technical teams that manage SIA-ABUCASIS and must maintain the API integration with FEDRA operational.
Practical example
A doctor at a Valencian public hospital detects on September 1, 2026 a suspected serious adverse reaction in a patient treated with a human medicinal product. He reports the case through the SIA-ABUCASIS system.
According to the agreement, the pharmacovigilance team of the Valencian Community has until September 11, 2026 (10 calendar days) for that notification to be registered in the AEMPS FEDRA database. The submission is performed automatically through the REST API with HTTPS, grouping the notification in a batch that can include up to 100 simultaneous cases. If the first submission attempt fails, the system executes automatic retries. If the problem persists, the incident management protocol provided for in the agreement is activated.
If the case had been non-serious, the deadline would be extended until November 20, 2026 (80 calendar days from receipt on September 1).
What should organizations do now?
- Verify the status of the API integration: technical managers of SIA-ABUCASIS must confirm that the REST API with HTTPS to FEDRA is operational since July 22, 2026, the date the agreement entered into force.
- Review internal notification flows: pharmacovigilance teams must map the process from when a healthcare professional reports a case until it reaches FEDRA, ensuring that internal deadlines allow compliance with the 10 days (serious) and 80 days (non-serious) established.
- Activate the incident management protocol: designate responsible parties and procedures to act when automatic retries do not resolve a submission failure, preventing notifications from remaining unregistered in FEDRA.
- Train notifying healthcare professionals: ensure that doctors, pharmacists, and nurses know the correct channels and deadlines for reporting suspected adverse reactions through SIA-ABUCASIS.
- Establish a monitoring system: implement alerts or periodic reviews to detect pending notifications that could compromise compliance with the agreement deadlines.
Frequently asked questions
What is the deadline for reporting serious adverse reactions to FEDRA according to this agreement?
The maximum deadline is 10 calendar days from receipt of the case. For non-serious adverse reactions, the deadline extends to 80 calendar days from receipt. Both deadlines are binding for the Valencian Community under the agreement signed with the AEMPS.
What computer systems does this agreement connect?
The agreement integrates the SIA-ABUCASIS system of the Valencian Community with the FEDRA database of the AEMPS. The connection is made through a REST API with HTTPS protocol, allowing submissions in batches of up to 100 notifications per submission, with automatic retries in case of failure.
Who is responsible for FEDRA security and who for the API?
The AEMPS assumes administration and security of the FEDRA database. For its part, the Valencian Generalitat is responsible for correct implementation of the API on its end, that is, in the SIA-ABUCASIS system. Each party has its scope of technical responsibility clearly defined in the agreement.
When did this agreement enter into force?
The agreement entered into force on July 22, 2026, although its publication in the BOE occurred on August 17, 2026 through the Resolution of July 24, 2026 from the AEMPS.
What happens if a notification submission to FEDRA fails?
The system contemplates automatic retries in case of submission failure. If the problem persists and retries do not resolve it, the incident management protocol included in the agreement is activated, which establishes the procedure to follow to ensure that notifications reach FEDRA correctly.
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-2026-17878