RegulatoryOfficial

AEMPS begins therapeutic positioning reports for medicines backed by CHMP in July

🇪🇸 AEMPS · Thu 22 Oct 2026

Spain's medicines agency has started work on therapeutic positioning reports for products with positive July CHMP opinions, with marketing-intention notices from holders determining when new-medicine reports begin.

The Spanish Agency for Medicines and Medical Devices (AEMPS) said on 22 October 2026 that it is starting therapeutic positioning reports (IPTs) for medicines that received a positive centralised-procedure opinion at the July 2026 meeting of the EMA's human medicines committee, the CHMP. The reports cover both new medicines and new or modified indications.

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

The same rule applies to new indications or modifications that come with a new presentation. For other new indications or modifications, the process starts without any notification from the MAH. Holders must also inform the same mailbox of any withdrawal of authorisation, change of ownership or change in marketing intentions.

The new medicines listed are Evlarco (obicetrapib/ezetimibe) and Ubeslo (obicetrapib), both from Menarini International Licensing; Icotyde (icotrokinra) from Janssen-Cilag International for plaque psoriasis; Lynavoy (linerixibat) from GlaxoSmithKline Trading Services for cholestatic pruritus in primary biliary cholangitis; Lyrokaul (lerodalcibep) from LIB Therapeutics for hypercholesterolaemia; Nezglyal (leriglitazone) from Minoryx Therapeutics for cerebral adrenoleukodystrophy in boys aged 2 to 12; and Zokovea (ensitrelvir) from Shionogi for post-exposure prophylaxis of COVID-19. Extensions include Enhertu with pertuzumab as first-line treatment of HER2-positive unresectable or metastatic breast cancer, and a Jivi extension; the source text is cut off before the Jivi details.

AEMPS also reminded stakeholders that the latest funding status for IPTs that include it should be checked in BIFIMED, its search tool on the financing status of medicines.

What it means for your team

  • MAHs with July CHMP positive opinions should decide on Spanish launch and email ipt@aemps.es, as no IPT starts for new medicines without that notice and a national code request.
  • Request national codes through RAEFAR II promptly where launch is planned, since this is the trigger for IPT drafting.
  • Notify AEMPS of withdrawals, ownership changes or altered marketing intentions using the same address.
  • Market-access teams should use BIFIMED for current funding status rather than relying on the IPT alone.

Official source: AEMPS ↗

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

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