Clinical Trials in Serbia: Why Foreign Sponsors Need Local Representatives

Serbia has become an attractive destination for international pharmaceutical and biotech companies seeking to conduct clinical trials. Competitive costs, experienced investigators, and a favorable regulatory environment make it a gateway for regional research in Southeast Europe.

However, for sponsors based outside Serbia, there is one non-negotiable requirement: the appointment of a Local Representative for clinical trials. This requirement can be surprising to foreign sponsors unfamiliar with the Serbian legal framework. Without a local representative or agent, no clinical trial authorization can move forward.

At the same time, many companies also encounter obligations to appoint a Data Representative under Serbian and EU-inspired data protection rules. While both roles involve “representation,” they serve very different purposes.

This post explains what a local representative is, why it matters, what foreign sponsors should expect, and how this compares with the data representative function.

Why Serbia Requires a Local Representative for Clinical Trials?

The Serbian Law on Medicines and Medical Devices requires that sponsors not established in Serbia appoint a local entity as their representative or agent. This ensures that:

• There is always a legally accountable contact in Serbia.
• ALIMS (Medicines and Medical Devices Agency of Serbia) can communicate effectively during the trial.
• Safety, regulatory reporting, and compliance obligations are fulfilled at the national level.

In practice, this means that a sponsor from the UK, US, or EU cannot directly submit an application to ALIMS. Instead, a Serbian company or agent must be named as the local representative and handle submissions.

Reason no. 1: Reporting Duties

Clinical trials in Serbia involve ongoing reporting to ALIMS beyond the initial authorization:

• Quarterly reports on trial progress must be submitted to confirm recruitment numbers, status, and any issues.
• Safety reporting requires that all serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) are communicated to ALIMS and the Ethics Committee within strict timelines.
• Amendments to the protocol, trial sites, or investigators must be submitted for approval before implementation.
• End-of-trial notifications and final study reports are mandatory to close the study with the authorities.

All of these steps require a point of contact in Serbia who can receive queries from ALIMS and ensure documents are filed correctly and on time. Without a representative, deadlines could be missed, exposing the sponsor to regulatory sanctions or even trial suspension.

Reason no. 2: Approval Process

When applying for initial approval, ALIMS and the national Ethics Committee review the Clinical Trial Application (CTA) dossier. If they issue deficiency letters or request clarifications, these must be responded to within the statutory deadline (commonly 30 days).

The local representative is essential here:

• ALIMS sends correspondence to the local contact.
• The representative must then forward it promptly to the sponsor and submit the sponsor-prepared answers back to ALIMS.
• Failure to respond in time can result in the application being rejected.

Reason no. 3: Technical Requirement – RIMS Portal and Electronic Signature

All submissions in Serbia must be made through the ALIMS RIMS portal. Access to this system is restricted:

• Only entities established in Serbia can create accounts.
• To sign and submit applications, the representative must use a qualified electronic signature (digital certificate issued in Serbia).

This means a foreign sponsor cannot technically submit documents directly, even if they prepared the entire dossier. The system requires a Serbian-based representative with valid e-signature credentials to complete the filing.

Is the Serbian framework aligned with the EU framework?

The Serbian clinical trial framework is closely harmonized with the European Union’s regulatory model.

Namely, much like in the EU, where non-EU sponsors must appoint a Legal Representative within the Union under the EU Clinical Trials Regulation (Regulation (EU) No 536/2014), Serbia requires foreign sponsors to appoint a Local Representative. The rationale is the same: ensuring there is a legally accountable entity inside the jurisdiction that authorities can contact and hold responsible for compliance.

Furthermore, Serbia follows the ICH-GCP guidelines and requires parallel approvals from ALIMS and ethics committees, which is consistent with EU practice. Safety reporting timelines and obligations are also aligned with EU pharmacovigilance standards, ensuring that trial data generated in Serbia can be accepted by EU regulators such as the EMA.

In effect, Serbia’s rules ensure that sponsors benefit from a predictable and EU-compatible regulatory environment, while authorities ensure that foreign sponsors remain fully accountable for the protection of trial participants and the integrity of clinical data.

What is the Role of the Local Representative for Clinical Trials?

The local representative acts as the sponsor’s regulatory proxy in Serbia. While the scope of responsibility can vary depending on the contract, it usually includes:

• Formal appointment as the sponsor’s agent in Serbia.
• Submission of the Clinical Trial Application (CTA) to ALIMS and, where applicable, the Ethics Committee.
• Forwarding communications from ALIMS to the sponsor and submitting sponsor-prepared responses.
• Handling official trial notifications, such as trial start, completion, and amendments.
• Maintaining local copies of regulatory documents and correspondence.

Why Foreign Sponsors Should Care?

The requirement to appoint a local representative in Serbia is not just a formal box-ticking exercise. It is a legal prerequisite without which a clinical trial cannot proceed.

• Without a Serbian representative, ALIMS will not even accept the clinical trial application. This means timelines for study start-up can collapse before they begin, no matter how well-prepared the sponsor’s documents are.
• Regulatory questions, deficiency letters, or safety alerts from ALIMS must be addressed quickly. Without a local representative, there is no valid channel for this communication, creating delays and risks to compliance.
• Sponsors who fail to appoint a representative risk fines, rejection of their application, or suspension of ongoing trials. This not only affects the Serbian arm of the study but can also undermine the credibility of the entire trial dataset if regulators question compliance.
• Trial sites and investigators in Serbia often rely on the local representative for clarity on regulatory approvals, protocol amendments, and document handling. Without someone in-country, sponsors face coordination issues and possible misunderstandings that slow recruitment and trial conduct.

By appointing a trusted local representative, sponsors gain assurance that:

• submissions will be filed properly and on time,
• official communications will be handled in accordance with Serbian law,
• and trial operations will not be disrupted by preventable regulatory issues.

In short, the local representative is the bridge between sponsor, authorities, and trial sites, making it a role that directly protects both compliance and trial timelines.

Distinguishing Between Local Representative for Clinical Trials and Data Representative

Foreign companies often confuse the Local Representative for clinical trials with the Data Protection Representative required under data protection law. While both are “representatives,” their purposes and legal bases are different.

In practice, foreign sponsors should plan on appointing two separate representatives when conducting clinical trials in Serbia:

• A Local Representative for Clinical Trials – This is indispensable for clinical trial authorization. Without it, ALIMS will not even review the application, and the trial cannot legally begin. The local representative ensures that the sponsor has a legally accountable presence in Serbia to receive and submit regulatory documents, manage trial notifications, and keep official records.
• A Data Representative – This becomes necessary whenever the sponsor processes personal data of Serbian citizens, which will almost always be the case in clinical trials. Even if the sponsor relies on a CRO for day-to-day operations, data such as patient health information, investigator details, or even monitoring records fall under Serbian data protection law. If the sponsor has no Serbian legal entity, they must appoint a Data Representative to serve as the point of contact for the Commissioner for Personal Data Protection and for individuals whose data is being processed.

Because clinical trials inherently involve both regulatory authorization and processing of personal data, the two roles are complementary rather than optional. One ensures compliance with medicines and clinical trial law; the other ensures compliance with data protection law.

Different Regimes, Parallel Obligations

Although both are “representatives,” the obligations do not overlap:

• The Local Representative “speaks the language” of ALIMS and clinical trial inspectors.
• The Data Representative “speaks the language” of the Serbian Data Protection Authority and ensures GDPR-style compliance.

Foreign sponsors should not assume that appointing one will cover the duties of the other. Each role responds to a different regulatory framework, and both regulators will expect to see that their respective representative is formally in place.