AEMPS Recommendations on Medicine Labeling Design in Spain

1. General Principles

The design of medicine labeling must prioritize clear product identification to prevent errors or confusion. Key information should form visual units on the main face of the packaging. The medicine name must appear on at least three non-opposing faces. Braille is mandatory on outer or primary packaging, with exceptions for certain injectables administered by healthcare professionals. Recommendations align with EMA QRD templates and EU guidelines, including standard terms for pharmaceutical forms and administration routes.

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos

Last update: January 3, 2022.

2. Key Elements on Labeling

• Medicine Name: Present the full name (brand name + strength + pharmaceutical form) as a visual unit on the main face. For generics, include 'EFG' where applicable.
• Strength and Active Substance: List below the name, following EMA recommendations on strength expression (e.g., prefer mg over g, avoid unnecessary decimals).
• Pharmaceutical Form: Use standard EDQM terms.
• Excipients: Full listing for parenteral, topical, and ophthalmic products; for others, only those with recognized effects, plus a reference to the package leaflet.
• Warnings and Special Information: Include required warnings; for non-prescription medicines, add therapeutic indication and target population.

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos

3. Legibility and Presentation

Critical information must be grouped for easy reading. Use appropriate spacing and separation (e.g., blue box for national information). Avoid elements that compromise legibility, such as optional logos.

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos

4. Symbols and Pictograms

• Mandatory symbols (e.g., prescription status, storage conditions) placed in the top right margin.
• Voluntary pictograms (e.g., driving warning, dosage tables, body parts for non-prescription medicines) allowed if they enhance understanding without promotional intent.
• SIGRE symbol for waste management (not for hospital-use products).

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos

5. Braille Requirements

The medicine name must be in Braille on the packaging, following EDQM standards. Exceptions apply for vaccines and injectables administered exclusively by professionals.

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos

6. QR Codes and Additional Features

QR codes may be included to provide supplementary information, distinct from EU safety features (unique identifier and anti-tampering device per Regulation 2016/161).

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos

7. Special Considerations

For certain products (e.g., radioactive medicines), include specific details like calibration date/hour. Stability statements follow QRD Appendix III.

AEMPS Información y recomendaciones en el diseño del etiquetado de los medicamentos