Bulletin on Medical Devices. April–June 2026
Bulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.
AEMPS (Spanish Medicine Agency) · SpainAEMPS (Spanish Medicine Agency)
Regulation
Category
Type
Date
AEMPS enables procedure for prior notification of in-house manufacture of in vitro diagnostic devices
AEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainEMA and HMA open comment period on new EU-IN guidance for investigators
EMA and HMA invite comments on updated EU-IN guidance describing scientific and regulatory support tools available nationally and at EU level for medicine and technology development.
AEMPS (Spanish Medicine Agency) · SpainPRAN launches public participation process for update of the Antimicrobial Therapeutic Guide of the NHS
PRAN opens consultation on updating its Antimicrobial Therapeutic Guide, inviting proposals for new clinical questions, scientific evidence and error corrections.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicines. July 2026
Monthly bulletin reporting new safety information from periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention communications.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicines. June 2026
Monthly safety bulletin reporting periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention information materials.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicines. May 2026
Monthly bulletin reporting new safety information from periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention materials.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicines, April 2026
Monthly safety bulletin reporting periodic pharmacovigilance data evaluation, authorised risk-prevention information, and other relevant safety matters.
AEMPS (Spanish Medicine Agency) · SpainAEMPS guidance on correct use of skin disinfectants
AEMPS publishes infographic guidance on appropriate and inappropriate uses of TP1 biocides for human hygiene.
AEMPS (Spanish Medicine Agency) · SpainAEMPS information on microplastics restriction and implications for biocidal products under its remit
Regulation 2023/2055 restricts marketing of products containing intentionally added microplastics; member state authorities agree this applies to AEMPS-regulated biocides.
AEMPS (Spanish Medicine Agency) · SpainAEMPS publishes guidance on simplified special registration applications for veterinary medicines
Guidance on the procedure, requirements and application form for simplified special registration of eligible veterinary medicines.
AEMPS (Spanish Medicine Agency) · SpainEuropean Commission publishes recommendations on identifying when cascade prescribing of veterinary medicines is justified
Guidance clarifies that authorised veterinary medicines do not automatically exclude cascade prescribing for a given species and indication.
AEMPS (Spanish Medicine Agency) · SpainAEMPS notification of entry into force of Implementing Regulation (EU) 2024/1973 on the use of certain antimicrobials in animals
Implementing Regulation (EU) 2024/1973 on antimicrobial use in animals enters into force on 8 August 2026.
AEMPS (Spanish Medicine Agency) · SpainEU expands fragrance allergens requiring labelling in cosmetics from 24 to 81
EU regulation expands fragrance allergens requiring individual labelling on cosmetic products from 24 to 81, effective August 2026.
AEMPS (Spanish Medicine Agency) · SpainAEMPS validates governance model and action plan for implementing the health technology assessment regulation
AEMPS establishes governance structure and implementation roadmap for coordinated application of the new European HTA framework.
AEMPS (Spanish Medicine Agency) · SpainSpain: pioneer in EU elimination of paper package inserts for hospital medicines
AEMPS expands paperless hospital-medicine project to 656 national codes (17% of hospital medicines marketed in Spain), with authorized information accessible digitally.
AEMPS (Spanish Medicine Agency) · SpainBulletin on the Safety of Human Medicinal Products, July 2025
Monthly safety bulletin reporting periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention information for human medicines.
AEMPS (Spanish Medicine Agency) · SpainIX National Conference of Research Ethics Committees for Medicines (CEIm)
Fecha de actualización: 09 de octubre de 2026 La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), en colaboración con la Sociedad Española de Farmacología Clínica (SEFC), organiza la IX Jornada Naciona...
AEMPS (Spanish Medicine Agency) · SpainAEMPS hosts IX National Conference of Research Ethics Committees for Medicines
Generar PDF Fecha de publicación: 02 de octubre de 2026 Categoría: medicamentos de uso humano Referencia: MUH, 10/2026 La jornada tendrá lugar el 21 de octubre en el Hospital Clínico San Carlos de Madrid y podrá segui...
AEMPS (Spanish Medicine Agency) · SpainICMRA publishes joint declaration to reduce animal use in human medicine development
ICMRA coalition, including AEMPS, calls for accelerated development and implementation of alternatives to animal testing in human medicines.
AEMPS (Spanish Medicine Agency) · SpainHuman Medicines Committee Bulletin. July 2026
Boletín del Comité de Medicamentos de Uso Humano. 30 de septiembre de 2026NIPO: 134-24-002-1 Información dirigida a profesionales sanitarios Índice Opiniones positivas para nuevos medicamentos Evlarco (obicetrapib/eze...
AEMPS (Spanish Medicine Agency) · SpainAEMPS announces new Health Technology Assessment System following Royal Decree 415/2026 approval
AEMPS will serve as Medicine Evaluation Office and participate in governance of new Health Technology Assessment System aligned with EU Regulation 2021/2282.
AEMPS (Spanish Medicine Agency) · SpainAEMPS informs on prohibition of cosmetic products containing TPO
Prohibition on use and marketing of cosmetic products containing Trimethylbenzoyl Diphenylphosphine Oxide (TPO) entered into force on 1 September 2025.
AEMPS (Spanish Medicine Agency) · SpainHuman Medicines Committee meeting, October 2026
Generar PDF Fecha de publicación: 14 de octubre de 2026 Categoría: medicamentos de uso humano Referencia: MUH (CMH), 08/2026 En esta nota informativa se enumeran los nuevos medicamentos de los que el CMH informó favor...
AEMPS (Spanish Medicine Agency) · SpainXV Meeting of the EAMI Network begins in Lisbon to establish new cooperation and regulatory strengthening pathways between Iberoamerican medicines authorities
Generar PDF Fecha de publicación: 22 de septiembre de 2026 Categoría: la AEMPS Referencia: AEMPS, 23/2026 La Red EAMI celebra su 30 aniversario con un encuentro que la consolida como un foro de diálogo, colaboración y...
AEMPS (Spanish Medicine Agency) · SpainEAMI Network advances in new strategic plan following 15th meeting in Lisbon
Generar PDF Fecha de publicación: 13 de octubre de 2026 Categoría: la AEMPS Referencia: AEMPS, 27/2026 La AEMPS, miembro permanente del Secretariado de la Red EAMI, ha intervenido en distintas sesiones del encuentro, ...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Committee on Veterinary Medicinal Products: September 2026 meeting
Generar PDF Fecha de publicación: 21 de septiembre de 2026 Categoría: medicamentos veterinarios, CODEM VET Referencia: MVET (CODEM VET) 08/2026 En esta nota se enumeran los nuevos medicamentos veterinarios de los que ...
AEMPS (Spanish Medicine Agency) · SpainAEMPS: Monovalent veterinary vaccines against IBR, PIF and rabies require OBPR certificate before release and marketing in Spain
Monovalent veterinary vaccines against IBR, PIF and rabies must obtain an OBPR certificate before release and marketing in Spain from 1 November 2026.
AEMPS (Spanish Medicine Agency) · SpainAEMPS reminder: how to avoid medication errors from vitamin D overdosing
AEMPS reminds healthcare professionals to review product information for calcifediol and cholecalciferol medicines to prevent serious hypercalcaemia from dosing errors.
AEMPS (Spanish Medicine Agency) · SpainAEMPS collaborates with Ghana's regulatory agency to strengthen capacity for biological medicine evaluation
AEMPS sends expert delegation to Ghana to provide training on European pharmaceutical regulation and evaluation institutions.
AEMPS (Spanish Medicine Agency) · SpainAEMPS awards fifth PRAN Prizes 2026 to nine antimicrobial resistance initiatives
Spanish medicines agency announces winners of annual awards recognising excellence and innovation in antimicrobial resistance.
AEMPS (Spanish Medicine Agency) · SpainAntibiotic consumption in Spain resumes downward trend, falling nearly 19% since 2015
Systemic antibiotic consumption in human health in Spain fell 5.1% in 2026 compared to 2024, the largest annual decline since before the COVID-19 pandemic.
AEMPS (Spanish Medicine Agency) · SpainAEMPS becomes first European agency to participate in international internship programme with Pan American Health Organization
Generar PDF Fecha de publicación: 27 de julio de 2026 Categoría: la AEMPS Referencia: AEMPS, 17/2026 El programa, que cuenta con el apoyo del Banco Interamericano de Desarrollo (BID), busca crear un puente de intercam...
AEMPS (Spanish Medicine Agency) · SpainAEMPS initiates therapeutic positioning reports for medicines with positive CHMP opinion from June meeting
AEMPS begins drafting therapeutic positioning reports for new medicines and new indications approved by CHMP in June.
AEMPS (Spanish Medicine Agency) · SpainAEMPS initiates therapeutic positioning reports for medicines with positive CHMP opinion from May meeting
AEMPS begins drafting therapeutic positioning reports for new medicines and new indications approved by the CHMP in May.
AEMPS (Spanish Medicine Agency) · SpainAEMPS participates in Vac-Med project to strengthen regulatory capacity in Latin America and the Caribbean
AEMPS delegation met with regional authorities in Dominican Republic to discuss biosimilar medicines regulatory framework.
AEMPS (Spanish Medicine Agency) · SpainAEMPS updates safety information for veterinary medicines containing phenobarbital
European review confirms favourable benefit-risk ratio; product information to include new warnings and recommendations on identified risks in dogs.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Human Medicines Committee meeting, September 2026
Generar PDF Fecha de publicación: 16 de septiembre de 2026 Categoría: medicamentos de uso humano Referencia: MUH (CMH), 08/2026 En esta nota informativa se enumeran los nuevos medicamentos de los que el CMH informó fa...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Bulletin on Cosmetics, Biocides and Personal Care Products, April–June 2026
Fecha de publicación: 27 de julio de 2026NIPO: 134-24-003-7 Productos cosméticos Legislación Vigilancia y control Otra información de interés Biocidas AEMPS y productos de cuidado personal Legislación Vigilancia y con...
AEMPS (Spanish Medicine Agency) · SpainHuman Medicines Committee meeting, July 2026
Generar PDF Fecha de publicación: 24 de julio de 2026 Categoría: medicamentos de uso humano Referencia: MUH (CMH), 07/2026 En esta nota informativa se enumeran los nuevos medicamentos de los que el CMH informó favorab...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Committee for Medicinal Products for Human Use: June 2026 meeting
Generar PDF Fecha de publicación: 22 de julio de 2026 Categoría: medicamentos de uso humano Referencia: MUH (CMH), 06/2026 En esta nota informativa se enumeran los nuevos medicamentos de los que el CMH informó favorab...
AEMPS (Spanish Medicine Agency) · SpainAEMPS and Plena Inclusión Madrid launch easy-read guide to promote safe sun exposure
AEMPS publishes easy-read guidance on sun protection recommendations in collaboration with Plena Inclusión Madrid.
AEMPS (Spanish Medicine Agency) · SpainCommittee for Medicinal Products for Veterinary Use: July 2026 meeting
Generar PDF Fecha de publicación: 21 de julio de 2026 Categoría: medicamentos veterinarios, CODEM VET Referencia: MVET (CODEM VET) 07/2026 En esta nota se enumeran los nuevos medicamentos veterinarios de los que el CO...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Alert: Dexcom G7 Application Alert Malfunction in iOS Version 2.12
Non-critical alerts may not sound in Dexcom G7 iOS version 2.12 when phone is in silent or focus mode.
AEMPS (Spanish Medicine Agency) · SpainBulletin on Veterinary Medicines, April–June 2026
Generar PDF Fecha de publicación: 21 de julio de 2026 NIPO: 134-24-004-2 El 54º Boletín sobre Medicamentos Veterinarios de los meses de abril, mayo y junio de 2026, publicado por la Agencia Española de Medicamentos y ...
AEMPS (Spanish Medicine Agency) · SpainAEMPS Committee on Veterinary Medicinal Products: June 2026 meeting
Generar PDF Fecha de publicación: 21 de julio de 2026 Categoría: medicamentos veterinarios, CODEM VET Referencia: MVET (CODEM VET) 06/2026 En esta nota se enumeran los nuevos medicamentos veterinarios de los que el CO...
AEMPS (Spanish Medicine Agency) · SpainAEMPS enables new application for electronic submission of responsible declaration for personal care product manufacturing and/or import activities
AEMPS launches an electronic application for manufacturers and importers to submit responsible declarations for personal care product activities.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Safety Alert: Unauthorized access risk in Albert e-motion M25 wheelchair drive system
Manufacturer reports two cybersecurity attack attempts on Albert e-motion M25 wheelchair system; no risk materialised; additional security measures implemented.
AEMPS (Spanish Medicine Agency) · SpainAEMPS Safety Alert: Possible battery internal fixation failure in TD Navio Midi and TD Navio Maxi augmentative and alternative communication devices
Manufacturer identified potential battery internal fixation defect in TD Navio Midi and Maxi devices; internal components may fail under strong impact or mechanical stress.
AEMPS (Spanish Medicine Agency) · SpainAEMPS alert: possible internal electrical component failure in certain Astral 100 and Astral 150 ventilators
Internal electrical component failure in Astral 100 and Astral 150 ventilators manufactured before October 2024 may interrupt therapy delivery.
AEMPS (Spanish Medicine Agency) · Spain
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