Working effectively with Baltic medicines authorities requires more than complying with EU pharmaceutical legislation. Although Estonia, Latvia and Lithuania operate within the same European regulatory framework, each country has its own competent authority, national procedures and practical expectations that can influence regulatory timelines and day-to-day interactions. Understanding these country-specific differences in national procedures, communication style, level of formality, and documentation expectations helps companies prepare stronger submissions, reduce unnecessary authority questions and keep regulatory projects on track.
This article highlights the practical expectations of Baltic medicines authorities, common questions raised during regulatory procedures, and key differences between Estonia, Latvia and Lithuania. It also shares practical tips to support efficient cooperation. The observations are based on hands-on regulatory experience and should be considered alongside current EU legislation and the latest national authority guidance.
What do Baltic medicines authorities expect from regulatory submissions?
Baltic medicines authorities expect submissions to be complete, well-structured and supported by clear regulatory justification. Applicants are also expected to provide consistent product information, complete administrative documentation and timely responses throughout the regulatory procedure.
Before each submission, applicants should verify the latest national authority guidance, applicable EU procedural requirements, and any country-specific instructions on format, language, fees, and supporting documentation.
In practice, this means ensuring that:
- Product information (SmPC, package leaflet and labelling) is consistent and aligned across all documents.
- Any proposed changes or country-specific deviations are clearly justified.
- Administrative documentation is complete at the time of submission.
- Responses to authority questions are provided promptly, clearly and in a structured format.
Although Baltic authorities are generally approachable and open to discussion, applicants are expected to have prepared their submissions thoroughly before engaging with the authority. Rather than relying on authorities to identify avoidable gaps, companies should aim to address potential issues proactively. Clear communication and good coordination are often just as important as technical regulatory knowledge.
What do Baltic medicines authorities commonly ask during assessments?
Baltic medicines authorities often raise similar questions during regulatory procedures when documentation is incomplete, inconsistent or lacks sufficient justification. The most commonly asked questions include product information, pharmacovigilance arrangements, administrative documentation and legal requirements. Many of these topics can be addressed before submission, helping to reduce avoidable delays.
Product information
Authorities frequently review whether product information is consistent with the reference procedure (RMS/CMS) and whether any national deviations are appropriately justified. When a common Baltic packaging procedure or Baltic three-language pack is planned, they also expect alignment of product information across Estonia, Latvia and Lithuania.
Pharmacovigilance arrangements
Pharmacovigilance documentation is another common area of review. Authorities may request confirmation of the Qualified Person for Pharmacovigilance (QPPV), details of the Pharmacovigilance System Master File (PSMF), and evidence that the marketing authorisation holder has appropriate systems in place to fulfil its pharmacovigilance obligations. Some national requirements, particularly in Lithuania, specify these expectations in greater detail.
Administrative documentation
Authorities also verify that submission packages are administratively complete. This includes checking application forms, fee payments and supporting documentation before the assessment progresses.
Legal and organisational requirements
Depending on the procedure, authorities may also request confirmation that the MAH is established within the EEA, that scientific service requirements are met where applicable, and that relevant agreements – such as documentation supporting a marketing authorisation transfer – are complete and valid.
How do Estonia, Latvia and Lithuania differ in practice?
The main differences between Baltic medicines authorities relate to documentation requirements, administrative processes and communication practices rather than differences in EU legislation itself. Understanding these practical differences can help companies prepare submissions more efficiently.
Estonia
Estonia’s competent authority, the State Agency of Medicines (Ravimiamet), is often regarded as pragmatic and efficient. Assessments typically focus on the clarity and completeness of the submission rather than unnecessary formalities. Well-prepared applications may therefore progress with relatively few rounds of authority questions.
Latvia
In Latvia, the competent authority is the State Agency of Medicines of Latvia (ZVA). The authority generally takes a balanced approach, combining regulatory flexibility with formal administrative requirements. Companies should allow sufficient time to address administrative matters, labelling and translations, while ensuring that national language requirements for product information are carefully addressed.
Lithuania
Lithuania’s competent authority, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (VVKT), is often considered the most documentation-focused of the three Baltic countries. Submission packages are expected to be comprehensive, and authorities may pay particular attention to administrative documentation, pharmacovigilance arrangements, product information, translations and packaging mock-ups.
Practical tips for successful cooperation with Baltic medicines authorities
1. Plan regionally, but prepare for national requirements
Develop a consistent regulatory strategy for Estonia, Latvia and Lithuania from the outset, while allowing for country-specific requirements. Early planning is particularly important for multi-country procedures, such as marketing authorisation transfers and common Baltic packaging, where changes in one market may affect the others.
2. Invest in submission quality
Well-prepared submissions reduce the likelihood of authority questions and help keep procedures on schedule. Before submission, check that documentation is complete, product information is consistent across all markets, and any country-specific deviations are clearly justified. If shared Baltic packaging is used, verify that all three language versions are aligned before submission.
3. Anticipate common authority questions
Many regulatory questions can be predicted based on the procedure, national guidance and previous experience. Where possible, address these proactively in the submission documentation or cover letter, particularly for product information, pharmacovigilance arrangements and marketing authorisation holder responsibilities.
4. Communicate clearly and proactively
When contacting an authority, describe the issue clearly, explain your proposed approach and request confirmation where appropriate. Well-structured communication helps authorities understand the context more quickly and can facilitate efficient handling of the procedure.
5. Adapt to country-specific practices
Although the overall regulatory framework is harmonised, each Baltic authority has its own working practices and expectations. Tailoring your approach to the country involved can improve communication and reduce unnecessary clarification requests.
6. Work with local regulatory expertise
Local regulatory knowledge can help identify country-specific requirements early, support communication with authorities and reduce the risk of avoidable delays. This is particularly valuable for complex procedures involving multiple Baltic markets.
Although Estonia, Latvia and Lithuania operate within the same regulatory framework, understanding country-specific requirements and maintaining clear, proactive communication can help reduce delays and support efficient regulatory processes. Whether you are planning a new marketing authorisation, managing lifecycle activities or coordinating submissions across the Baltic region, local regulatory expertise can make the process more efficient.
Medfiles provides regulatory affairs services across Estonia, Latvia and Lithuania, supporting pharmaceutical companies throughout the product lifecycle – from marketing authorisations and lifecycle maintenance to pharmacovigilance and regulatory compliance. 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 compliant regulatory activities across Lithuania, Latvia and Estonia.
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:
- Planning a marketing authorisation transfer in the Baltic countries: key considerations
- 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
- Global healthcare company & Medfiles: Ensuring quality and continuity in post-approval RA and PV activities
