European Commission Revises Guideline on Drug Package Information

The European Commission has released a final revision to its guideline on packaging information, detailing new provisions for drugmakers seeking EU marketing authorization. The guideline pays particular attention to label content, companion leaflets and package design.

EU law allows some leeway for member states to require labeling information beyond that which is mandated by the law, including the following:

• Product price;

• Reimbursement conditions of national coverage organizations;

• Legal status for supplying the product to patients; and

• Authenticity and identification in accordance with labeling and package leaflet rules.

Information specific to a member state should be located in a single boxed area — the so-called “blue box” — and appear on one side of the package. Each “blue box” should be presented in the country’s official language or languages, the guideline notes. When one pack is intended for marketing in several member states, the box should contain different information relevant for each state.

Drug packs must include a companion leaflet unless the required information is fully presented in the labeling. The leaflet should be in the local language and “reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use,” the guideline states.

If the medicine is not intended for direct dosing to the patient, or if serious availability issues exist, the concerned competent authority may grant a full or partial exemption to the language obligations, it adds.

The guideline provides details on label presentation, noting the requirements for size, design and composition.

An appropriate range of package sizes should be selected based on the duration of treatment and dosing outlined in the summary of product characteristics. Package size should not be influenced by local prescribing habits.

To minimize the chance of confusion due to linguistic variations, the guideline advises drugmakers to use the same logo, format, layout, style, color scheme and, if possible, package dimensions on all versions of a drug marketed in the EU.

Packaging isn’t the only thing that the EU has updated recently. As part of a push to improve pharmacovigilance across the EU, authorities are cracking down hard on medication errors. ADE? Or ADR? Medication Error Case Studies for Successful EU Compliance will help you avoid any preventable adverse events. Sign up to participate in this webinar now.