Which language should be a medicine series quality certificate in?

On May 16th, 2019 the Law of Ukraine “On Ensuring Functioning Ukrainian as State Language” (hereinafter – the Law), which provides that the only state (official) language in Ukraine is Ukrainian, was published.

Article 13(6) of the Law specifies that state authorities, authorities of the Autonomous Republic of Crimea, local authorities, state and communal enterprises, institutions and organizations accept for consideration documents in Ukrainian except for cases prescribed by law.

The abovementioned articles of the Law become effective on July 16th, 2019.

In connection with this it should be solved which language should be used to make documents for medicines, in particular, medicine series quality certificates submitted to the State Service for Medicines and Drug Control upon customs clearance of goods.

The Law does not prescribe any exceptions for language of quality certificate and other documents related to import and realization of medicines. Transition period has not been provided as well.

Currently, under paragraph 5 of the Procedure for State Control Over Quality of Medicines Imported to Ukraine approved by Resolution of the Cabinet of Ministers of Ukraine No. 902 as of September 14th, 2005 (hereinafter – the Procedure), series quality certificate must be accompanied by translation (language of translation is not specified). Due to this, there are cases when this document is translated into Russian, for example.

Therefore, starting from July 16th, 2019 rules of the resolution on translation of the certificate should be interpreted as per provisions of the Law.

Pursuant to the Law, we consider it possible to draw medicine series quality certificates in one of the following ways:

1. Original certificate in Ukrainian;
2. Original certificate bilingual (for example, in Ukrainian and Russian);
3. Original certificate in a foreign language accompanied with translation into Ukrainian certified with signature of head or authorized person of commercial entity, with its seal affixed (if any).

Otherwise, state authorities will have legal grounds to refuse to accept and consider such a document.

The Language Law coming into effect will touch upon a lot of other issues related to document flow in pharmaceutical companies. In particular, it concerns submission of registration file for medicines.

All are invited to learn more about practical aspects of changes in company activities according to the Law of Ukraine “On Ensuring Functioning Ukrainian as State Language” at the seminar “Language Law: Changes in Company Activities” on June 24th.

Please contact Natalia Lavrenova, associated partner at Legal Alliance Company, with all questions on this subject at lavrenova@l-a.com.ua.