A common Baltic pack can be implemented by aligning labelling text early, planning multilingual packaging from the outset, and coordinating submissions across Lithuania, Latvia and Estonia to ensure consistency throughout the product lifecycle.
Lithuania, Latvia and Estonia are often treated as a single market, but when it comes to packaging, they must be approached as three separate regulatory environments. For Marketing Authorisation Holders (MAHs), a common Baltic pack can streamline operations, reduce complexity and support timely market access – provided that regulatory and practical aspects are carefully coordinated.
Because three languages must typically fit on the same packaging, planning is critical. Decisions made during the marketing authorisation procedure, from text selection to layout, directly affect whether packaging can be implemented efficiently across all three countries. Overly detailed labelling text, inconsistent terminology or uncoordinated national submissions can create challenges later in the product lifecycle.
What determines whether a common Baltic pack is feasible
When planning multilingual packaging in the EU, several key principles should be considered:
- Legal basis: Directive 2001/83/EC, Article 63, permits the use of multilingual text on packaging, provided that the same information appears in all languages used. An exception is the blue box, which can contain nationally specific information without affecting the harmonised core text.
- EU-harmonised text: For products authorised via MR/DC procedures, the labelling text is harmonised across Member States. For nationally authorised products, differences in labelling text are more likely, and some Member States, including the Baltic countries, offer local procedures for labelling harmonisation, which facilitate the availability of the medicine.
- Reduced harmonised text: CMDh guidance encourages applicants to consider reduced harmonised text where possible, particularly when multilingual text must fit on a single pack. This approach improves legibility, optimises space, and facilitates the creation of multilingual packaging.
- Early alignment: Agreeing on full or reduced harmonised text during the MR/DC procedure reduces the risk of later changes during the national phase and helps prevent layout issues on outer and immediate packaging
What practical differences need to be considered in the Baltics
Even with harmonised procedures, several country-specific elements must be considered to ensure that a common Baltic pack is feasible and compliant. These factors are particularly important for outer and immediate packaging, especially for small packs, where space constraints are most pronounced.
- Language length and translation coordination
- Differences in text length between the three languages should be considered.
- Coordinating submission proposals across all three countries early helps prevent layout adjustments and ensures consistent placement of critical information.
- Use of Latin terminology and shortened terms for space optimisation
- Some labelling elements may be stated in Latin, or shortened terms may be used instead of full standard terms – for example, for active substance names, excipients, or pharmaceutical form.
- Consistent application across Lithuania, Latvia and Estonia during the national phase helps optimise available space and supports harmonised layout.
- Specific national (blue-box) requirements
- For the Baltic countries, these requirements are minimal, mainly covering legal status if not already included in the approved labelling text.
- In practice, the blue box may often remain empty, except for the market names in local languages, and generally does not significantly affect the common pack.
- Responsibility for labelling artworks
- In the Baltic countries, authorities approve the labelling text, not the final artworks. Artworks themselves are not subject to approval by the authorities.
- It is the MAH’s responsibility to ensure that the outer and immediate packaging artworks are fully compliant with the approved text, including all language versions and formatting.
- Proper coordination during national phase submissions and common pack planning helps prevent inconsistencies and layout issues.
When and how to use the Common Baltic Package Procedure
- The Common Baltic Package Procedure is a voluntary initiative designed to address labelling differences between Lithuania, Latvia and Estonia that could prevent the creation of a common pack.
- In practice, it is primarily intended for nationally authorised products, where differences in labelling text between countries are more likely.
- The procedure may also be applied to MR/DC products, as it allows certain adjustments to reduce text amount (e.g., switching elements to Latin or using shortened standard terms) even if the EU-harmonised text is already aligned.
- In practice, the procedure applies to labelling changes referred to in Article 61(3) of Directive 2001/83/EC:
- A Reference Baltic State (RBS) coordinates the assessment of the proposed labelling text.
- The RBS shares proposals with the other Baltic States (Concerned Baltic States, CBS), who review and provide feedback within a defined timeline.
- The process includes agreement on English and national translations, coordinated submission, and finalisation of the common pack text.
- In case of changing the language of active substances and excipients from national to Latin, a formal application is not required; a request sent by e-mail is sufficient, in line with the procedure.
- By using this procedure, companies can facilitate packaging alignment, improve availability, and avoid delays caused by text inconsistencies or national-specific differences.
What happens after launch: variations and lifecycle management
Challenges do not end with the initial creation or launch of a common pack. Throughout the product lifecycle, careful management is required:
- Variation implementation: Variations resulting in updates to labelling text, and consequently to the artworks, must be coordinated across Lithuania, Latvia and Estonia to ensure alignment and prevent differences between countries.
- Differing approval timelines and transitional (grace) periods: Each authority may approve variations at different speeds or allow different transition periods, affecting when updated packs can be released.
- Operational alignment: Early planning, coordination, and communication with authorities are essential to ensure that updated artworks are implemented consistently, avoiding supply delays or compliance issues.
Proactively managing variations and lifecycle updates ensures that the common Baltic pack remains aligned, compliant, and available throughout the product’s market life.
Our team of regulatory experts provides tailored support to Marketing Authorisation Holders throughout the entire process – from early packaging planning and multilingual coordination to the Common Baltic Package procedure and lifecycle management of variations. Our experts are based in all three Baltic countries, speak the local languages and are familiar with national regulatory requirements. By partnering with us, MAHs can ensure smooth, timely, and fully compliant implementation of their products across Lithuania, Latvia and Estonia.
See also:
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
- Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
- Planning a marketing authorisation transfer in the Baltic countries: key considerations
- Promotional material compliance in the Baltics
