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AEMPS starts therapeutic positioning reports for September CHMP-backed medicines

🇪🇸 AEMPS · Thu 22 Oct 2026

Spain's medicines agency has begun work on IPTs for products with a positive CHMP opinion in September 2026, with a marketing-intention step for new medicines.

The Spanish Agency for Medicines and Medical Devices (AEMPS) has begun preparing therapeutic positioning reports (Informes de Posicionamiento Terapéutico, IPT) for medicines that received a positive centralised-procedure opinion from the EMA's CHMP at its September 2026 meeting. The notice is referenced IPT, 09/2026. The reports cover new medicines as well as new indications or modifications of existing ones.

For new medicines, AEMPS will start drafting only once the marketing authorisation holder (MAH) tells it whether it intends to market the product in Spain and requests the national code. MAHs are asked to write to ipt@aemps.es, state whether they intend to market each product, and give a contact point. Those who do intend to market must request the national code through the RAEFAR II application. If AEMPS receives no confirmation and no code is requested, it will not begin the IPT.

New indications or modifications are handled differently. Where they are linked to a new presentation, the same rule applies: the IPT starts after the MAH confirms its marketing intention and the national code has been requested. Otherwise, drafting begins without any communication from the MAH. Withdrawals of authorisation, changes of ownership and changes in marketing intention must also be reported to the same address.

The notice lists the products concerned. The available extract names Novo Nordisk's Frehemgo (denecimig), indicated for routine prophylaxis of bleeding episodes in haemophilia A with or without FVIII inhibitors, and SFL Pharmaceuticals Deutschland's Gevalka (ensartinib). The text is cut off after that, so the full list cannot be confirmed here. AEMPS also reminds readers that current funding status, where an IPT contains it, should be checked in its BIFIMED search tool.

What it means for your team

  • MAHs with September CHMP-positive new medicines should tell AEMPS at ipt@aemps.es whether they plan to market in Spain, and request the national code via RAEFAR II. Without these steps, no IPT will start.
  • For new indications or modifications not tied to a new presentation, drafting starts without any MAH action. Teams should still prepare for the IPT process.
  • Market-access teams should use BIFIMED for the latest funding status and should report withdrawals, ownership changes or revised marketing intentions to AEMPS.
  • This is a market-access process notice, not a safety or pharmacovigilance action.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

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