AEMPS

What AEMPS does

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is the Spanish national regulatory authority for human medicines, veterinary medicines, medical devices, cosmetics and personal care products, and biocides. Operating as an autonomous body under Spain's Ministry of Health (Ministerio de Sanidad), AEMPS is responsible for ensuring the quality, safety, efficacy, and proper commercialization of medicines and health products within Spanish jurisdiction. It coordinates with the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM), and acts as Notified Body 0318 for the CE marking of medical devices under ENAC accreditation with IAF MLA mark recognition.

AEMPS's operational backbone is its electronic administration platform, the Sede Electrónica (sede.aemps.gob.es), which provides centralized digital access to all regulatory procedures in compliance with Spain's Ley 39/2015 on Common Administrative Procedure. The platform comprises approximately twenty domain-specific web applications, including RAEFAR for human medicines registration, RAEVET for veterinary medicines, LABOFAR for pharmaceutical inspection and control, SIFAEX for border pharmaceutical inspection, CCPS and CNCps for medical device registration and CE marking, COSMET for cosmetic product declarations, BPCP for biocides, NotificaCS for cosmetic adverse effects, and VIGÍA-VET for veterinary pharmacovigilance. Authentication is handled through digital certificates, electronic IDs, or the Cl@ve platform, with SSL 128-bit encrypted communications. The platform integrates with European infrastructure including the CESP (Common European Submission Portal) and EMA eSubmission portal, and supports seven languages (Spanish, Catalan, English, Basque, Galician, Portuguese, and Valencian).

AEMPS operates as a non-commercial public entity funded through Spain's national budget and administrative fees (tasas) levied under Article 123 of Real Decreto Legislativo 1/2015. Revenue is not publicly disclosed. Its customer base is constituted by regulated industries (pharmaceutical laboratories, medical device manufacturers, cosmetics and biocide producers, hospitals, Spanish autonomous communities with pharmaceutical inspection powers, and economic operators handling import/export of health products), none of which have alternative Spanish regulators available to them. The organization is headquartered at C/ Campezo 1, Edificio 8, Parque Empresarial Las Mercedes, 28022 Madrid.

Name

AEMPS

Legal name

Agencia Española de Medicamentos y Productos Sanitarios

Website

https://sede.aemps.gob.es

Company type

Public

Operating status

Operating

Headcount range

51–100 employees

Short description

Spanish national regulatory authority for human and veterinary medicines, medical devices, cosmetics, and biocides, operating under the Ministry of Health. AEMPS delivers electronic regulatory procedures via its Sede Electrónica platform, serving pharmaceutical firms, device manufacturers, and healthcare institutions across Spain.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

akta.pro primary industry

Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ)

akta.pro secondary industries

Certified Compliance & Reporting Services (R2/e-Stewards, Audit, ESG) (BPALAIAL), EHS Auditing, Inspections & Assurance (BPAHAJAG)

Keywords

• Pharmaceutical regulatory services
• Medicines authorization
• Medical device certification
• Pharmacovigilance monitoring
• Electronic administration platform

Headquarters

HQ city

Madrid

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Distribution channels1 record

Marketing channels2 records

Core offering

AEMPS operates the electronic headquarters (Sede Electrónica) for the Spanish pharmaceutical and health products regulatory authority, providing web-based administrative applications for the registration, authorization, inspection, pharmacovigilance, and certification of human medicines, veterinary medicines, medical devices, cosmetics, biocides, and personal care products. The agency also functions as Notified Body 0318 for CE marking of medical devices and issues ISO 13485 quality management certifications under ENAC accreditation.

Product overview

AEMPS operates a comprehensive e-Administration platform called 'Sede Electrónica' (Electronic Headquarters) offering multiple interconnected web applications for regulatory management of medicines, medical devices, cosmetics, biocides, and personal care products. The platform serves pharmaceutical companies, healthcare professionals, and competent authorities through a unified electronic procedures portal. Key products include: RAEFAR (human medicines registry) and RAEVET (veterinary medicines registry) for medicine authorization management; LABOFAR for pharmaceutical inspection and control; CCPS and CNCPs for medical device commercialization and certification; SIFAEX for border pharmaceutical inspection; and specialized applications for cosmetics (COSMET, CERTCOS_CLV), biocides (BPCP), pharmacovigilance (VIGIA-VET), and clinical investigations. Most applications require digital certificates, Cl@ve authentication, or electronic signature for secure access, and are accessible via the centralized https://sinaem.aemps.es portal. The platform enables electronic submission of applications, document management, certificate requests, and regulatory compliance tracking across the Spanish pharmaceutical regulatory ecosystem.

Differentiator

Problem solved

Functional benefit

Products and services

• Sede Electrónica (Electronic Headquarters)

Segments10 records

Ideal customer profiles7 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature19 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde): Portuguese national authority for medicines and health products. Closest Iberian peer with near-identical scope (medicines, medical devices, cosmetics) and operates parallel electronic submission platforms recognized under the same EU regulatory framework as AEMPS.
• AIFA (Agenzia Italiana del Farmaco): Italy's national pharmaceutical agency. Comparable regulatory scope (medicines authorization, pharmacovigilance, inspections) and uses similar electronic portals for industry, paralleling AEMPS's Sede Electrónica model.
• BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): Germany's federal institute for drugs and medical devices. Mirrors AEMPS's regulatory scope including marketing authorizations, clinical trial approvals, and notified body activities for medical devices, with similar statutory standing within its national health ministry.
• EDQM (European Directorate for the Quality of Medicines & HealthCare): Council of Europe body coordinating OMCL network and OCABR batch release. AEMPS participates in this network and runs COMPE under Article 41 of RD 1345/2007 in alignment with EDQM procedures for blood-derived medicines.
• Swissmedic (Schweizerisches Heilmittelinstitut): Swiss authority for therapeutic products. Directly comparable in scope (human/veterinary medicines, medical devices) and operates an equivalent electronic submission platform; closely aligned with EU MRA partners that work alongside AEMPS.
• ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé): France's national medicines and health products regulator. Operates an analogous scope (medicines, medical devices, cosmetics, biocides) with parallel electronic procedures; directly comparable to AEMPS in mandate, structure, and fee-driven revenue model.
• European Medicines Agency (EMA): EU-wide regulator for human and veterinary medicines. AEMPS coordinates with EMA on centralized authorizations, eSubmission (referenced in RAEVET), and pharmacovigilance, and serves as a member-state competent authority that contributes to EMA's work-sharing procedures.
• MHRA (Medicines and Healthcare products Regulatory Agency): UK regulator for medicines, medical devices, and blood components. Shares AEMPS's full lifecycle oversight (clinical trials through pharmacovigilance), post-Brexit equivalent competent authority, and operates a comparable fee-based model for CE marking and marketing authorizations.

Regional players

• Health Canada — Health Products and Food Branch: Canadian regulator for health products and food. Comparable function to AEMPS across medicines and medical devices with similar fee-based structure, though operating under a different jurisdictional framework.
• TGA (Therapeutic Goods Administration): Australia's regulator for therapeutic goods. Comparable mandate across medicines, medical devices, and biologicals; comparable to AEMPS in fee-funded structure and breadth of regulatory categories covered.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/aemps

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about AEMPS