Marketing authorisation transfers are common in the pharmaceutical industry. They may result from mergers and acquisitions, strategic portfolio decisions or market expansion. For companies, transferring a marketing authorisation can enable entry into new markets, expansion of product portfolios or consolidation of operations.
Estonia, Latvia and Lithuania are often grouped together as the Baltic countries. From a regulatory perspective, however, they should not be treated as a single market. Each country has its own language, national legislation and medicines authority, and certain national practices still differ despite more than 20 years of EU membership.
These differences become particularly visible when planning a marketing authorisation holder (MAH) transfer. While the overall regulatory framework is similar, the practical handling of transfers varies between the three countries. MAH transfers are typically resource-intensive projects, making it particularly important to understand these differences early in the planning phase.
Language requirements: no single-language Baltic packaging
One of the most common practical misunderstandings concerns packaging language requirements. Each Baltic country requires its own national language for labelling and the package leaflet. This means that the three countries cannot share a single-language pack.
In practice, companies often use trilingual packaging (Estonian–Latvian–Lithuanian) to optimise production volumes for the Baltic markets, allowing a single packaging configuration to be used across all three countries.
Another point that is sometimes overlooked is responsibility for the final packaging text. While the authorities approve the product information, the MAH – and where applicable the manufacturer – remains responsible for ensuring that the packaging exactly matches the approved wording. This means that every language version and packaging component should be checked carefully before release.
Planning the transfer between the current and future MAH
A Marketing Authorisation Holder transfer effectively begins before any documents are submitted to the authorities. The first step is usually an agreement between the current MAH and the future MAH on the practical implementation of the transfer. Two questions are particularly important:
- What is the realistic transfer date?
- How will the transition from old to new packaging be managed?
In practice, companies usually aim to release products with the old MAH details before the transfer date. At the same time, preparation of the new packaging can already begin. This preparation does not need to wait for formal approval, provided that the implementation timeline is carefully coordinated.
Differences in MAH transfer procedures in Estonia, Latvia and Lithuania
A key difference between the Baltic countries concerns the regulatory procedure used for the MAH transfer. In Estonia and Latvia, the change of Marketing Authorisation Holder is handled as a Type II variation.
In Lithuania, however, the MAH transfer follows a separate national marketing authorisation transfer procedure. Because of this, the submission strategy and application handling differ somewhat from the other Baltic countries.
There are also differences in how applications can be grouped. For example:
- In Estonia, several medicinal products can be included in one application, provided that the current and future MAH are the same for all products.
- In Lithuania, different strengths and pharmaceutical forms under the same trade name may be included in one application, but different trade names require separate application forms.
Documentation required for MAH transfer applications
Although procedural details differ between the Baltic countries, the core documentation requirements are largely comparable. Typically, the following documentation is required:
- Application and procedural documents – such as cover letter, application form, and, where applicable, proof of payment of state fees.
- MA transfer agreement – a signed agreement between the parties clearly identifying the medicinal products concerned, specifying the effective date of transfer of all rights and obligations of the MAH, and confirming that the complete marketing authorisation dossier is made available to the future MAH.
- Documentation from the new MAH – including proof of establishment within the EEA (e.g. extract from the commercial register) and, where required, pharmacovigilance documentation, namely the summary of the Pharmacovigilance System Master File (PSMF), confirming that an appropriate pharmacovigilance system, including a designated QPPV, is in place.
- Updated product information – proposed SmPC, labelling, and package leaflet reflecting only MAH transfer-related changes.
Accuracy in basic information is important. Even small inconsistencies – such as differences in the spelling of the company name or address – may slow down the procedure.
Submission responsibilities and timelines in the Baltic countries
In principle, the MAH transfer application can be submitted by either the current MAH or the future MAH. In practice, however, the submission is usually filed by the current (valid) MAH. If the application is submitted by the future MAH, authorisation from the current MAH must be provided.
Submission timing is an important consideration. In Estonia and Latvia, where the transfer is handled as a Type II variation, submissions are typically planned at least two months before the intended transfer date in order to ensure that the approval is issued in time.
Lithuania follows a different approach. The authority usually issues its decision within 30 days, but the applicant may indicate a desired transfer date that can be set up to six months after submission. This date functions as the implementation date for both the transfer of MAH rights and obligations and updates to product labelling.
Until that date, the MAH information in the authority database and the approved product information remain unchanged.
Coordinating MAH transfers across the Baltic countries
Understanding the differences in approval timelines, submission requirements and implementation mechanisms is particularly important when coordinating MAH transfer submissions for medicines marketed using a common Baltic package.
Medfiles supports MAHs throughout the process – from preparing and aligning the necessary documentation to coordinating submissions across Estonia, Latvia and Lithuania. Our experts are based in all three Baltic countries, speak the local languages and are familiar with national regulatory requirements, helping to ensure a smooth, timely and compliant transfer process.
Author: Veiko Sildever, Senior Regulatory Affairs Expert, Baltics
Veiko Sildever has worked at Medfiles since 2016 and has extensive experience in regulatory work across the Baltic countries. He has experience in leading the product portfolio of a major client operating in Estonia, Latvia and Lithuania, coordinating regulatory activities across a wide range of product categories.
Veiko graduated with honours from Tallinn Healthcare College. He has also completed additional studies in psychology at the University of Tartu, as well as several professional courses in regulatory affairs and distribution. Before joining Medfiles, Veiko worked in pharmaceutical companies and at the Tallinn City Ambulance.
At Medfiles, Veiko’s work includes managing product lifecycles, preparing and reviewing variation packages, coordinating CESP submissions for Estonia and Latvia, and maintaining communication with clients and regulatory authorities.
Having worked with pan-Baltic regulatory projects for many years, he has strong practical knowledge of the regulatory requirements and working practices of the Estonian, Latvian and Lithuanian authorities. In addition to Estonian, he can work with documentation in neighbouring languages such as Finnish and Latvian, which helps streamline regulatory processes across the region.
See also:
- Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
- What regulatory lifecycle activities must MAH manage after approval?
- How to implement common Baltic packs for human medicines
- Promotional material compliance in the Baltics
- Global pharma company & Medfiles: Obtaining and maintaining marketing authorisations in the EU
