AEMPS and Bidafarma: new early warning system for drug shortages

Key data

Pharmaceutical distributors and community pharmacies will have an unprecedented mechanism for early warning against drug shortages. The Resolution of July 24, 2026 from AEMPS publishes the agreement signed with Bidafarma, Sociedad Cooperativa Andaluza, by which both entities will exchange wholesale supply data on a weekly basis.

The objective is to detect tensions in the supply chain before they become actual shortages, something that until now was only possible to react to when the problem had already reached the pharmacy or the patient.

What does this regulation establish?

The agreement regulates the exchange of wholesale information between Bidafarma SCA and AEMPS. The key elements of the agreement are:

• Data provided by Bidafarma: quantities requested and quantities actually received of each medicine, with weekly submission to AEMPS.
• Analysis tool: AEMPS will process this information through the ARTEMIS platform, its pharmaceutical supply chain monitoring system.
• Alert generation: ARTEMIS will produce alerts covering the entire chain, from manufacturer to community pharmacy, allowing intervention at the exact point where tension originates.
• Results dissemination: aggregated data will be shared with FEDIFAR (Federation of Pharmaceutical Distributors) to encourage other wholesale distributors to join the same model.
• Regulatory framework: the agreement is framed within the Supply Guarantee Plan 2025-2030 and EU Regulation 2022/123, which establishes the European framework for managing pharmaceutical crises.

The agreement has an initial validity of 4 renewable years and imposes no economic obligations on either of the two signing parties.

Economic and operational impact

For companies in the sector, the impact is not direct cost —the agreement is explicit that it generates no economic obligations— but rather operational and strategic:

• Distributors adhering to the model: must prepare systems for extracting and sending weekly data in the format established by AEMPS. This may require adaptations to their warehouse management or ERP systems.
• Community pharmacies: will be recipients of alerts generated by ARTEMIS, allowing them to anticipate stock shortages and manage orders with greater advance notice.
• Laboratories and manufacturers: alerts also cover the manufacturing stage, so they could receive early warnings of increased demand or tension in certain active ingredients.
• Other distributors: the dissemination of aggregated results through FEDIFAR seeks to encourage more wholesalers to voluntarily join the data exchange, expanding system coverage.

The true economic impact is indirect but significant: an early warning system reduces the risk of shortages, which in previous episodes has generated crisis management costs, emergency therapeutic substitutions and loss of patient confidence.

Who does it affect?

• Bidafarma SCA: signatory party to the agreement, with obligation to submit weekly data.
• Other wholesale pharmaceutical distributors: not yet obligated, but FEDIFAR will act as a transmission mechanism for their voluntary incorporation.
• Community pharmacies: will receive early alerts that will improve their stock management.
• Pharmaceutical laboratories and manufacturers: the system covers the entire chain, including the production stage.
• Healthcare professionals: benefit indirectly by reducing episodes of unavailable medicines.
• Patients: final recipients of the improvement in medicine availability.

Practical example

Imagine that a high-turnover active ingredient —for example, a chronic-use antihypertensive— begins to show a divergence between the quantities requested by pharmacies from Bidafarma and the quantities Bidafarma receives from the manufacturer.

With the previous system, that tension was only detected when pharmacies started running out of stock and patients could not pick up their medication.

With the new agreement: Bidafarma sends that week to AEMPS the data on requests vs. receipts. ARTEMIS detects the divergence and generates an alert. AEMPS can contact the manufacturer, activate measures from the Supply Guarantee Plan 2025-2030 or redistribute existing stock among distributors, before the pharmacy —and the patient— notice the problem.

What should companies do now?

1. Wholesale pharmaceutical distributors: contact FEDIFAR to learn about the timeline and technical requirements for voluntary participation in the data exchange system with AEMPS.
2. Systems managers in distributors: review whether ERP or warehouse management systems can generate weekly reports of quantities requested vs. received in the format established by AEMPS.
3. Community pharmacies: verify that their communication channels with AEMPS and their distributor are updated to receive early alerts from ARTEMIS.
4. Laboratories and manufacturers: review internal procedures for notifying supply tensions to AEMPS, in line with the Supply Guarantee Plan 2025-2030.
5. All supply chain actors: familiarize themselves with EU Regulation 2022/123, the European reference framework in which this agreement is inscribed and which may generate additional obligations in the future.

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-2026-16828