Regulation

National authorities

EU product law is enforced by national authorities. For parapharmacy products this typically means the national medicines agency for medicines, devices and cosmetics, and a separate food agency for food supplements. The principal authorities in the major European jurisdictions are listed here.

France — ANSM

Agence nationale de sécurité du médicament et des produits de santé (National agency for the safety of medicines and health products). ANSM is the French public-establishment responsible for medicinal products and certain other health products including medical devices. It carries out marketing-authorisation work for medicines, post-market surveillance, inspection of pharmaceutical establishments and market surveillance for devices. Cosmetics market surveillance in France is shared between ANSM and the consumer-protection agency DGCCRF. Food supplements are supervised principally by the DGCCRF and on safety questions by ANSES (the food, environmental and occupational health and safety agency). Website: ansm.sante.fr.

Italy — AIFA and Ministero della Salute

Agenzia Italiana del Farmaco (AIFA, Italian Medicines Agency) is the public body responsible for medicinal products in Italy, including marketing-authorisation, pharmacovigilance and pricing/reimbursement for nationally authorised medicines. The Ministero della Salute (Ministry of Health) is responsible for medical devices, cosmetics market surveillance, food supplements and the regulation of pharmacies and parafarmacie. Food safety enforcement is shared with the regions. Websites: aifa.gov.it; salute.gov.it.

Spain — AEMPS

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS, Spanish Agency for Medicines and Medical Devices). AEMPS is the Spanish autonomous body responsible for medicines, medical devices and cosmetics. Food supplements and the broader food-safety regime are the responsibility of the Agencia Española de Seguridad Alimentaria y Nutrición (AESAN). The Spanish autonomous communities (regions) hold competences on pharmacy regulation, inspection and consumer protection within their territory. Websites: aemps.gob.es; aesan.gob.es.

Portugal — INFARMED

INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde (National Authority of Medicines and Health Products). INFARMED is the Portuguese autonomous body responsible for medicines and medical devices, including the registration of locais de venda de medicamentos não sujeitos a receita médica. Food supplements are supervised by the Direção-Geral de Alimentação e Veterinária (DGAV) and the food-safety authority ASAE. Cosmetics market surveillance is shared between INFARMED and other agencies. Website: infarmed.pt.

Belgium — FAMHP (AFMPS / FAGG)

The Federal Agency for Medicines and Health Products (FAMHP in English, AFMPS in French, FAGG in Dutch). The Belgian federal agency for medicines and medical devices, also competent for certain related products. The Belgian FPS Health, Food Chain Safety and Environment (SPF Santé publique / FOD Volksgezondheid) supervises food supplements and food law generally; the Federal Agency for the Safety of the Food Chain (AFSCA / FAVV) is the food-safety enforcement body. Website: famhp.be.

Germany — BfArM, PEI and BVL

Germany operates a tripartite federal structure. The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, Federal Institute for Drugs and Medical Devices) supervises most medicines and medical devices. The Paul-Ehrlich-Institut (PEI) is responsible for biological medicines, vaccines and certain blood products. The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL, Federal Office of Consumer Protection and Food Safety) is responsible for food and consumer goods including cosmetics; food supplements are also within its scope, jointly with the federal states (Länder). Cosmetic enforcement is largely a Länder competence under federal coordination. Websites: bfarm.de; pei.de; bvl.bund.de.

United Kingdom — MHRA and FSA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK body responsible for medicines and medical devices. Following the UK's departure from the EU, the UK has its own medicines and medical-device regimes, with distinct requirements for devices placed on the Great Britain market (UKCA marking is being phased in) and separate arrangements for Northern Ireland under the relevant protocol. Food supplements and cosmetics in the UK are supervised by the Food Standards Agency (FSA) and the Office for Product Safety and Standards (OPSS) respectively. Websites: gov.uk/mhra; food.gov.uk.

EU-level bodies

Several EU institutions hold competences directly relevant to parapharmacy products:

• European Commission, Directorate-General for Health and Food Safety (DG SANTE), policy lead on cosmetics, medical devices, food supplements and medicinal products: health.ec.europa.eu.
• European Medicines Agency (EMA), scientific assessment of medicinal products at central level: ema.europa.eu.
• European Food Safety Authority (EFSA), scientific assessment for food and food supplements: efsa.europa.eu.
• Scientific Committee on Consumer Safety (SCCS), advising the Commission on cosmetics: health.ec.europa.eu.

Last reviewed: May 2026.