Labelling Exemptions and Foreign Packaging in the EU/EEA: A Practical Guide for Regulatory Strategy

Within the Europe, pharmaceutical companies must comply with strict labelling requirements to ensure patient safety, product traceability, and regulatory conformity. However, there are specific scenarios where full compliance with national labelling regulations may hinder timely access to essential medicines. Labelling exemptions and the use of foreign-language packaging offer structured, legally supported solutions that preserve safety while enabling flexibility.

Why Labelling Matters

Medicinal product labelling is governed by Regulation (EC) No 726/2004 and Directive 2001/83/EC. These rules mandate the inclusion of critical details such as product name, strength, pharmaceutical form, active ingredients, expiry date, batch number, and safety warnings. Labels must be in the official language(s) of the country in which the product is marketed, include Braille for accessibility, and adhere to readability standards issued by the European Medicines Agency (EMA).

These measures support proper use by healthcare professionals and patients, maintain pharmacovigilance standards, and build public trust. However, in certain situations, flexibility is necessary to maintain medicine availability.

When Are Labelling Exemptions Applicable?

Orphan Medicines

Medicines for rare diseases often fall under labelling exemptions due to limited demand. While the EU allows for certain packaging to appear in another member state’s language, a national-language package leaflet is typically still required. These exemptions may be included in the initial marketing authorisation and managed at both EU and national levels.

Shortage-Driven Exemptions

Products authorised via the EMA’s centralised procedure may qualify for labelling exemptions when justified by manufacturing or market conditions. Requests must identify affected packaging components and include mock-ups. Only physical labels may be exempted; digital translations are still required. Deadlines for exemption requests are strict and depend on the stage of the application process.

Hospital-Only Medicines

Medicines used exclusively in hospitals may be exempt from full national language labelling, especially when urgently needed. These exemptions typically allow for English-only packaging or reduced label content, provided the essential information is still accessible to healthcare professionals. They are always temporary and evaluated on a case-by-case basis.

Centralised vs. National Procedures

For centrally authorised products, companies must submit translation exemption requests to the EMA. These must include justifications, detailed mock-ups, and specify the labelling components involved. The EMA’s Quality Review of Documents (QRD) group assesses these requests, which are typically limited to physical packaging. Digital materials must still be available in all required languages.

At the national level, procedures vary considerably across member states. While the legal foundation is shared, the criteria, timelines, and scope of permissible exemptions differ by country. Understanding these local variations is essential for timely and compliant product distribution.

Case Examples from EU Member States

The following examples illustrate how different countries implement labelling exemptions:

• Poland: Under Polish Pharmaceutical Law, exemptions may be granted for orphan drugs or products with serious availability issues. These can cover partial or full translation waivers. Applications must specify the scope, justification, time frame, and product quantity.

• Finland: A pilot allows English-only packaging for certain hospital-use medicines. Special permits are also available for products without marketing authorisation. These permits are issued by Fimea, the Finnish Medicines Agency.

• Spain: The Spanish Agency for Medicines and Health Products (AEMPS) may approve the use of unauthorised or unmarketed medicines under Royal Decree 1015/2009. Requests require a physician’s prescription and supporting clinical documentation.

• Italy: For centrally authorised products, pharmacists may print PILs locally when national packaging is not feasible. MAHs reimburse printing costs through agreements with Unifarm. Exemptions are not permitted for nationally authorised products.

• Baltic States (Lithuania, Latvia, Estonia): Foreign packaging is permitted if the equivalent product is not distributed locally. A translated PIL must be attached, and approval is granted via notification to the national authority.

Digital Innovation: ePI and the Transition Ahead

The electronic Product Information (ePI) system is designed to improve how healthcare professionals access up-to-date information. By integrating with hospital systems, ePI enables real-time updates, multilingual access, and streamlined workflows. A pilot programme completed in 2024 confirmed its efficiency in reducing labelling errors and enhancing shortage management. Full implementation is expected by 2030.

Lessons from COVID-19

The COVID-19 pandemic underscored the value of regulatory flexibility. Exemptions were introduced to enable rapid vaccine deployment, allowing for English-only packaging, QR codes for PIL access, overlabelling in local languages, and temporary waivers under the Falsified Medicines Directive. While these were emergency measures, they set important precedents for future crisis response.

Looking Ahead

Regulators across Europe are increasingly open to harmonisation and digitalisation in labelling. Multilingual packaging, broader use of ePI, and expanded exemption frameworks are being explored to address supply chain resilience and reduce administrative burden.

For companies operating in the EU/EEA, a well-informed and proactive regulatory strategy is crucial. Understanding exemption pathways, preparing compliant documentation, and engaging early with authorities will help ensure uninterrupted market access while maintaining the highest standards of patient care.