AEMPS and Cofares share weekly data to prevent medicine shortages: what changes for distributors and pharmacies

Key data

Pharmaceutical distributors in Spain are entering a new era of data transparency. Since July 22, 2026, Cofares is required to report weekly to the Spanish Agency for Medicines and Health Products (AEMPS) the volumes of wholesale medicine supply, under the agreement published in the BOE on August 1, 2026 (reference BOE-A-2026-16829).

The objective is clear: detect before a stock break occurs. Spain has suffered recurring episodes of essential medicine shortages in recent years, and this agreement is the first operational piece of the Supply Guarantee Plan 2025-2030, which in turn aligns with EU Regulation 2022/123 on medicine supply crisis management.

What does this regulation establish?

The agreement formalizes a structured information flow between two key actors in Spain's pharmaceutical distribution system. These are the essential elements of the agreement:

The mechanism is simple: Cofares sends weekly data on how much has been requested and how much has actually been received for each medicine. The gap between both figures is the alert signal. ARTEMIS detects those gaps and allows AEMPS to act before shortages reach pharmacies and, ultimately, patients.

Results do not stay at AEMPS: they are shared in aggregated form with FEDIFAR (Federation of Pharmaceutical Distributors), with the explicit purpose that other wholesalers see the value of the system and join voluntarily.

Economic and operational impact

The agreement generates no direct economic costs for either party. However, it has relevant operational implications for the sector:

• Weekly reporting burden for Cofares: The cooperative must structure, validate and send supply data on a weekly basis. This involves adapting internal order and inventory management systems to generate reports in the format required by AEMPS.
• Indirect pressure on other distributors: By sharing aggregated results with FEDIFAR, AEMPS seeks for other wholesalers to join. Those who do not will be in a position of lower visibility before the regulator in a context of increasing supply scrutiny.
• Reduction of shortage risk: For pharmacies and hospitals, a functional early warning system can reduce stock breaks that generate operational costs, complaints and loss of patient confidence.
• Expanding regulatory framework: EU Regulation 2022/123 already requires Member States to strengthen supply surveillance. This agreement is the practical implementation in Spain and may anticipate future formal obligations for more sector actors.

Who does it affect?

• Cofares: Direct obligation to report weekly wholesale supply data.
• Other wholesale pharmaceutical distributors: Indirect impact through FEDIFAR; possible pressure to voluntarily join the system or future regulatory obligation.
• Pharmacies: Beneficiaries of the early warning system; lower risk of stock breaks in essential medicines.
• Hospitals and healthcare centers: Potential improvement in medicine supply predictability.
• Healthcare professionals: Reduction of situations where they must manage therapeutic alternatives due to medicine shortage.
• Patients: Final beneficiaries of a more resilient distribution system.
• Pharmaceutical laboratories: Aggregated data may reveal demand patterns affecting their production and distribution decisions.

Practical example

Imagine that during a given week, pharmacies associated with Cofares request 500,000 units of a hypertension medicine, but the distributor only receives 320,000 units from the manufacturing laboratory. That 36% gap between requested and received is recorded in the weekly report Cofares sends to AEMPS.

ARTEMIS automatically detects that deviation, AEMPS can contact the laboratory to understand the reason (manufacturing problem, logistics delay, parallel export) and activate preventive measures: export restrictions, search for alternative suppliers or communication to healthcare professionals to manage inventories.

Without this system, the alert would arrive weeks later, when pharmacies were already out of stock and patients without medication. With the agreement, AEMPS acts at the wholesale phase, before the problem reaches the pharmacy counter.

What should companies do now?

1. If you are Cofares or manage its IT systems: Immediately review order and inventory management systems to ensure they can generate weekly reports in the format required by AEMPS from the entry into force date (July 22, 2026).
2. If you are another wholesale pharmaceutical distributor: Contact FEDIFAR to learn about the aggregated results that AEMPS will share and evaluate the convenience of voluntarily joining the system before it becomes a regulatory obligation.
3. If you manage a pharmacy or pharmacy chain: Review internal shortage management protocols and ensure you have active channels with your wholesale distributor to receive early warnings.
4. If you are a pharmaceutical laboratory: Anticipate that AEMPS will have more granular data on actual wholesale market demand, which may result in requirements for additional information or more agile regulatory measures in case of supply problems.
5. For all sector actors: Familiarize yourself with the framework of EU Regulation 2022/123 and the Supply Guarantee Plan 2025-2030, as this agreement is only the first piece of a surveillance system that will be expanded.

Official source

Consult complete regulation in official source (BOE-A-2026-16829)

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-2026-16829