Structure of Medicinal Product Names in Spain – AEMPS Guidelines

Purpose of Naming Rules

The structure of a medicinal product name in Spain must ensure unambiguous identification, avoid confusion with other products, and support pharmacovigilance and safe dispensing. AEMPS follows EU harmonised principles while applying national requirements, particularly for language and format. Names must be clear, precise, and not misleading regarding composition, strength, or therapeutic use. Estructura del nombre de un medicamento - AEMPS

Main Components of the Name

A complete medicinal product name typically includes:

• Invented name (brand/trade name): Optional; must be unique and approved. Can be a fantasy name or include elements suggesting therapeutic action only if justified and non-misleading.
• Common name / INN: The international non-proprietary name (recommended by WHO) or equivalent Spanish denomination when no INN exists. This is mandatory.
• Pharmaceutical form: Standardised term (e.g., comprimidos recubiertos con película, solución inyectable).
• Strength / concentration: Quantitative expression of active substance(s) (e.g., 500 mg, 10 mg/ml).
• Route of administration (if relevant and not evident from form): e.g., vía oral, intramuscular.
• Container / presentation (when necessary for differentiation): e.g., envase de 30 comprimidos.

The order is usually: Invented name + strength + pharmaceutical form (+ route/container if needed). Example: “Paracetamol AEMPS 500 mg comprimidos”.

Specific Requirements and Restrictions

• Language: The name must be in Spanish (or co-official languages in respective autonomous communities). Latin terms are allowed only for pharmaceutical form when no Spanish equivalent exists.
• Prohibited elements: Names must not include therapeutic claims (e.g., “anti-dolor”, “curativo”), misleading indications of superiority, or terms that could confuse with food/cosmetic products.
• Homonyms / similarity: AEMPS rejects names too similar to existing authorised products to prevent dispensing errors.
• Generics and biosimilars: Must include INN + company identifier or “genérico”/“biosimilar” when applicable.
• Fixed combinations: Active substances listed in alphabetical order or established convention.

Practical Examples and Variations

• Branded: “Ibuprofeno Kern Pharma 600 mg comprimidos recubiertos con película”
• Generic: “Ibuprofeno 600 mg comprimidos recubiertos con película EFG”
• Combination: “Amoxicilina/Ácido clavulánico Sandoz 875 mg/125 mg comprimidos recubiertos con película”

Variations may occur for paediatric, modified-release, or multi-strength products. AEMPS reviews and approves proposed names during the marketing authorisation process.

Implications for Marketing Authorisation Holders

Holders must ensure the proposed name complies with these rules at application stage. Changes to the name post-authorisation require variation procedures. Clear naming supports traceability, reduces medication errors, and aligns with EU Directive 2001/83/EC as amended and national legislation. Detailed criteria, examples, and consultation are available on the AEMPS dedicated naming structure page. Estructura del nombre de un medicamento - AEMPS