Medicinal Product Naming Structure in Spain – AEMPS Requirements

Regulatory Foundation

The naming of medicinal products authorised for human use in Spain is regulated by Royal Decree 1345/2007 (implementing Directive 2001/83/EC as amended) and specific AEMPS technical guidelines. The structure aims to guarantee clear identification, avoid medication errors, facilitate pharmacovigilance, and ensure correct dispensing by healthcare professionals and patients. Names must be precise, non-misleading, and consistent across labelling, packaging, and SmPC. Estructura del nombre de un medicamento - AEMPS

Compulsory Elements of the Name

Every authorised medicinal product name must include:

• Common / International Non-Proprietary Name (INN): The WHO-recommended INN in Spanish or the official Spanish denomination if no INN exists. This is the core mandatory element.
• Strength / quantitative composition: Expressed clearly (e.g., 500 mg, 10 mg/ml, 1 g/100 ml).
• Pharmaceutical form: Using standardised Spanish terms from the AEMPS list (e.g., comprimidos recubiertos con película, solución inyectable en vial).
• Route of administration (only when necessary for distinction or not obvious from the form): e.g., vía oral, intramuscular.

The standard order is: INN + strength + pharmaceutical form (+ route if required). Example: “Ibuprofeno 600 mg comprimidos recubiertos con película”.

Rules for Invented Names

• Invented (brand/trade) names are optional but widely used.
• Must be unique and approved by AEMPS during the marketing authorisation procedure.
• Cannot include therapeutic claims (e.g., “antigripal”, “analgésico rápido”), superlatives (e.g., “máximo”, “extra”), or misleading elements suggesting superiority, efficacy guarantees, or non-medicinal nature.
• Fantasy names are preferred; inclusion of active substance(s) or therapeutic hints is restricted and requires strong justification.

Special Naming Cases

• Generics: Must use INN + strength + form + “EFG” (Equivalente Farmacéutico Genérico) or the marketing authorisation holder’s identifier.
• Biosimilars: Include “biosimilar” in the name when required by regulation.
• Fixed combinations: Active substances listed alphabetically or according to established convention (e.g., “Amoxicilina/Ácido clavulánico”).
• Modified-release / paediatric / multi-strength products: May include qualifiers such as “prolongada liberación”, “pediátrico”, or strength differentiation.
• Language: Names must be in Spanish (or co-official languages in respective autonomous communities); Latin permitted only for pharmaceutical form when no Spanish equivalent exists.

Approval Process and Post-Authorisation

AEMPS reviews and approves proposed names during the marketing authorisation application. Post-authorisation changes to the name require a variation procedure (type IA, IB, or II depending on scope). AEMPS maintains a public database of authorised names and publishes rejection criteria to promote consistency and patient safety.

These requirements, harmonised with EU standards while incorporating national specificity, reduce dispensing risks, enhance traceability, and support informed use throughout the medicinal product lifecycle. Full criteria, standardised terminology lists, and practical examples are available on the AEMPS dedicated page for medicinal product naming structure. Estructura del nombre de un medicamento - AEMPS