Key data
| Regulation | Resolution of 14 July 2026, from the AEMPS, publishing the Agreement with Federació Farmacèutica, SCCL |
|---|---|
| BOE Publication | 23 July 2026 |
| Entry into force | 10 July 2026 |
| Affected parties | Pharmaceutical distributors, pharmacies, healthcare professionals and patients |
| Category | Regulatory Changes |
| Agreement validity | 4 years, renewable for 4 additional years |
| Economic cost | No economic obligations for the parties |
| Technological tool | ARTEMIS (wholesale data exchange platform) |
| Reporting frequency | Weekly |
| Regulatory framework | Supply Guarantee Plan 2025-2030 and EU Regulation 2022/123 |
Pharmaceutical distributors and pharmacies in Spain have a new surveillance mechanism on the table. As of 10 July 2026, the AEMPS and Federació Farmacèutica, SCCL share weekly wholesale supply data through the ARTEMIS tool, with the aim of anticipating shortages before they become a problem for patients and healthcare professionals.
The agreement, published in the BOE on 23 July 2026 through the Resolution of 14 July 2026 from the AEMPS, is part of the Supply Guarantee Plan 2025-2030 and the EU Regulation 2022/123 on pharmaceutical crisis management at European level.
What does this regulation establish?
The agreement formalizes a structured information flow between the AEMPS and Federació Farmacèutica, SCCL. The key elements of the agreement are as follows:
- Reported data: Federació Farmacèutica will communicate weekly the quantities requested and received for each medication in the wholesale channel.
- Technological channel: All information is channeled through the computer tool ARTEMIS, managed by the AEMPS.
- Alert generation: With this data, the AEMPS will be able to generate early warning alerts for possible shortages before they materialize at the point of dispensation.
- Aggregated dissemination: The resulting analyses will be shared in aggregated form with FEDIFAR, with the aim of encouraging the participation of other pharmaceutical distributors in the system.
- Legal framework: The agreement is based on the Supply Guarantee Plan 2025-2030 and the EU Regulation 2022/123, which regulates pharmaceutical crisis management at European scale.
- Validity: The agreement has a duration of 4 years, automatically renewable for 4 additional years.
- Cost: The agreement does not generate economic obligations for any of the parties.
Economic and operational impact
Although the agreement does not involve direct costs, its operational impact is relevant for the entire pharmaceutical distribution chain:
- For distributors: Federació Farmacèutica assumes the obligation to generate and transmit structured weekly data through ARTEMIS. This requires adapting internal information systems to comply with the required format and frequency.
- For pharmacies: Early detection of stock breaks will allow anticipating supply problems and better managing orders, reducing shortage situations that today are detected when the patient can no longer receive their medication.
- For other distributors: The dissemination of aggregated analyses through FEDIFAR opens the door for more industry players to join the system, which could lead to future similar reporting obligations for distributors that do not currently participate.
- For the healthcare system: The reduction of shortage episodes has a direct impact on care continuity and patient safety.
Who does it affect?
- Wholesale pharmaceutical distributors operating through Federació Farmacèutica, SCCL, with direct obligation to report weekly.
- Other pharmaceutical distributors integrated in FEDIFAR, who will receive aggregated analyses and could join the system in the future.
- Pharmacies and pharmacy offices that depend on wholesale supply to guarantee dispensation to their patients.
- Healthcare professionals (doctors, nurses, hospital pharmacists) who manage treatments with medications susceptible to shortage.
- Patients with chronic treatments or high dependence on medications with a history of scarcity.
- Laboratories and marketing authorization holders, who may be indirectly affected by the alerts generated by the AEMPS.
Practical example
A wholesale distributor integrated in Federació Farmacèutica manages the supply of a medication for chronic diseases with high demand. Each week, its warehouse management system uploads to ARTEMIS the data of units requested by pharmacies and units actually received from the laboratory.
If for three consecutive weeks the units received are significantly lower than those requested, the AEMPS detects the deviation and activates an early warning alert for possible shortage. This allows the regulator to contact the laboratory, explore alternative supply sources or inform healthcare professionals in advance so they can adjust prescriptions.
Without this system, the stock break would only be detected when the pharmacy could no longer dispense the medication to the patient, with the clinical and care impact that entails. With ARTEMIS, the reaction margin goes from days to weeks.
What should companies do now?
- Verify if you operate under Federació Farmacèutica, SCCL: If you are a wholesale distributor integrated in this cooperative, the agreement is already in force as of 10 July 2026 and you must comply with weekly reporting through ARTEMIS.
- Review the compatibility of your systems with ARTEMIS: Check that your warehouse management software can export the data of quantities requested and received in the format required by the AEMPS platform.
- Designate an internal reporting manager: Assign a person or team the responsibility of ensuring that weekly data is transmitted correctly and on time.
- If you are a distributor in FEDIFAR but not in Federació Farmacèutica: Monitor the aggregated analyses you will receive and evaluate whether your organization can or should join the active reporting system in the future.
- If you are a pharmacy: You have no direct reporting obligations, but take advantage of the early alerts that the AEMPS will generate to anticipate possible supply problems and manage your stock with greater reaction margin.
- Review the framework of the Supply Guarantee Plan 2025-2030: This agreement is just one piece of a broader plan. Stay informed about future obligations that may arise from the plan for your segment of the pharmaceutical chain.
Frequently asked questions
What data must Federació Farmacèutica report to the AEMPS and how often?
Federació Farmacèutica must report weekly the quantities requested and received for each medication in the wholesale channel. Transmission is carried out through the computer tool ARTEMIS, managed by the AEMPS. No minimum threshold of medications is established: the report covers all products in the managed catalog.
How long does the agreement between AEMPS and Federació Farmacèutica last?
The agreement has an initial validity of 4 years from its entry into force on 10 July 2026, with the possibility of renewal for 4 additional years. It does not generate economic obligations for any of the parties.
What is ARTEMIS and how does it work in this agreement?
ARTEMIS is the AEMPS computer tool through which pharmaceutical wholesale data is channeled. Federació Farmacèutica uploads weekly supply data to this platform, and the AEMPS analyzes it to generate early warning alerts for possible shortages.
What role does FEDIFAR play in this agreement?
FEDIFAR is not a signatory party to the agreement, but will receive the aggregated analyses generated by the AEMPS from Federació Farmacèutica data. The objective is for FEDIFAR to encourage the participation of other pharmaceutical distributors in the information exchange system, thus expanding the coverage of the early warning system.
Does this agreement require all pharmacies to report data?
No. Pharmacies have no direct reporting obligations under this agreement. The obligation falls on Federació Farmacèutica, SCCL, as a wholesale distribution entity. Pharmacies will benefit indirectly from the early alerts generated by the AEMPS to anticipate supply problems.
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-2026-16086