Changing the Authorised Representative in Ukraine: What Manufacturers Should Know

Over the past two weeks, several manufacturers contacted us regarding the change of their Authorised Representative (AR) in Ukraine.

In most cases, the reason was the same: the existing partner combined the functions of distributor and AR, blocking the manufacturer’s ability to work with other importers or distribute products independently.

Who is the Authorised Representative

The Authorised Representative (AR) acts on behalf of a foreign manufacturer in Ukraine.

Their responsibilities include:

• communicating with the State Service of Ukraine on Medicines and Drugs Control (SMDC);

• maintaining technical documentation and declarations;

• providing post-market surveillance and reporting incidents;

• ensuring that labeling and documentation comply with MDR/IVDR requirements.

In essence, the AR is the legal bridge between the manufacturer and Ukrainian authorities — but not the commercial controller of distribution.

Typical Mistakes by Manufacturers

Manufacturers often make the same mistake: assigning the role of AR to their exclusive distributor.

This seems convenient at first, but over time it leads to conflicts — especially if the distributor tries to block access for other importers.

In all recent cases, manufacturers faced the same problem: the current AR/distributor refused to provide authorisation letters for imports by other companies. As a result, the manufacturer lost control over its own market presence.

Another critical issue is lack of direct access to documentation.

Manufacturers must always have their own copies of technical files, declarations, and certificates, regardless of the AR’s actions.

In practice, difficulties often arise because the current representative refuses to transfer documentation or technical files, forcing the manufacturer to rebuild the full documentation package from scratch.

How to Avoid Problems

To protect your business interests, we recommend:

1. Separate commercial and regulatory functions.
   
   The AR should be an independent entity or at least contractually separate from the distributor.

2. Clearly define responsibilities in the contract.
   
   The agreement should specify ownership of technical documentation, confidentiality clauses, and procedures for changing the AR.

3. Control your registration data.
   
   Ensure that you have up-to-date copies of all documents — technical files, declarations, certificates, and SMDC submissions.

Changing the Authorised Representative is not just signing a new contract. The process includes:

• preparation of a manufacturer’s letter confirming termination of the previous AR;

• submission of updated technical documentation and declarations by the new AR;

• updating the information in the SMDC database and on product labelling (the new AR’s contact details must appear on the packaging).

In practice, difficulties often arise due to the previous representative’s reluctance to transfer documentation or technical files. In such cases, the manufacturer may need to prepare the full set of documents again.

Conclusion

The role of the Authorised Representative in Ukraine is often underestimated, yet it determines the legality of a product’s presence on the market.

Mistakes in choosing or changing the AR can lead to loss of market access, documentation, or even liability for violations of technical regulations.

An independent Authorised Representative is not merely a legal requirement — it is a tool for control and protection of the manufacturer’s interests.