February 13, 2025

While Spain is generally covered by the EU GMP guidelines as detailed in EudraDex Volume 4, the  AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios) or Spanish Agency of Medicines and Medical Devices is responsible for new drug applications, clinical trials, and enforcement, along with additional Spanish national requirements.

AEMPS authorization and inspection regulations are detailed In the Spanish Royal Decree (Real Decreto)824/2010, which is generally harmonious with EU GMP. Spain is a member of the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which promotes international harmonization of GMP standards. Spain also works closely with the European Medicines Agency (EMA), that aligns pharmaceutical approvals and production with EU provisions.

Dietary Supplements in Spain are covered by two publications:

• Real Decreto 1487/2009, for vitamins and minerals
• Real Decreto 130/2018, for other supplements

This legislation is like that developed in other EU Member States.

Cannabis in Spain; currently, there are no regulations for cannabis, except medicinal use is illegal, and recreational use is decriminalized. Curiously, it is legal to purchase cannabis seeds and growing equipment.

E-liquids in Spain are covered by Real Decreto 579/2017 for production, sale, and presentation of e-liquids, with guidelines on delivery devices. There are restrictions on nicotine levels, ingredients, and vaping locations. Real Decreto 579/2017 was revised in 2024 largely to account for the risks of vaping health and passive smoking.

The regulations in Spain generally follow those of the EU for general harmony, especially for the pharmaceutical industry. For the EU, we have found the areas of Inventory Management, Electronic Batch Records (EBR), and Quality Management to be of special interest. However, regional differences from AEMPS should also be investigated.

For more information about how InstantGMP covers the EU standards, look here, or give us a call.

References

AEMPS  www.aepms.gob.es

Merieux NutriSciences Spain, “Spain—New Regulation for Food Supplements”, Maria Crespan, 4/30/2018

Wikipedia www.wikipedia.com

www.spaincheck.com for Spanish legal affairs on e-liquids

Cannigma www.cannigma.com for cannabis Laws in Spain