Naming Rules for Human Medicines in Spain – AEMPS Framework

Legal Basis and Objective

The naming of authorised human medicines in Spain is governed by national legislation implementing EU Directive 2001/83/EC (as amended) and specific AEMPS guidelines. The primary objective is to ensure clear, unambiguous identification of the product to prevent medication errors, support pharmacovigilance, and facilitate safe dispensing by healthcare professionals and patients. Names must not be misleading regarding composition, strength, therapeutic indications, or superiority over other products. Legislación sobre medicamentos de uso humano – Nombre de medicamentos - AEMPS

Mandatory Elements in the Name

A complete authorised name typically comprises:

• Common name / Denominación común — The international non-proprietary name (INN) recommended by WHO, or the Spanish official denomination if no INN exists. This element is compulsory.
• Pharmaceutical form — Standardised term in Spanish (e.g., comprimidos recubiertos con película, solución inyectable) as per the AEMPS list of standardised forms.
• Strength / concentración — Quantitative expression of the active substance(s) (e.g., 500 mg, 10 mg/ml).
• Route of administration (when not evident from the form or necessary for distinction): e.g., vía oral, intramuscular.

The order is generally: Common name + strength + pharmaceutical form (+ route if required). Example: “Paracetamol 500 mg comprimidos”.

Invented Names (Brand/Trade Names)

• Optional but common for originator and branded generics.
• Must be unique, approved by AEMPS during marketing authorisation, and not conflict with existing names.
• Cannot include misleading therapeutic claims (e.g., “rápido alivio”, “extra fuerte”), superlatives implying superiority, or elements suggesting food/cosmetic nature.
• Fantasy names are preferred; inclusion of active substance or therapeutic hints is restricted and requires justification.

Special Cases and Variations

• Generics: Must include the common name + strength + form + “EFG” (Equivalente Farmacéutico Genérico) or company identifier.
• Biosimilars: Include common name + “biosimilar” when required.
• Fixed-dose combinations: Active substances listed alphabetically or per established convention (e.g., “Amoxicilina/Ácido clavulánico”).
• Paediatric / modified-release / multi-strength products: May require additional qualifiers (e.g., “pediátrico”, “prolongada liberación”).
• Language: Full name in Spanish (or co-official languages in respective autonomous communities); Latin allowed only for pharmaceutical form when no Spanish equivalent exists.

Approval and Post-Authorisation Changes

Proposed names are reviewed and approved by AEMPS during the marketing authorisation process. Post-authorisation name changes require a type IA/IB/II variation depending on impact. AEMPS maintains a database of authorised names and publishes rejection criteria to ensure consistency and safety.

These rules, aligned with EU harmonisation while incorporating national specificity, reduce dispensing risks and enhance traceability throughout the medicine’s lifecycle. Detailed criteria, standardised terms, and examples are provided on the AEMPS legislation page for human medicines naming. Legislación sobre medicamentos de uso humano – Nombre de medicamentos - AEMPS