Language and labeling

Cratia provides professional services on the registration (renewals, variations), safety and quality management for medicines in 12 countries and the Eurasian Economic Union (EAEU):

Azerbaijan Georgia Moldova Turkmenistan
Armenia Kazakhstan Mongolia Uzbekistan
Belarus Kyrgyzstan Tajikistan Ukraine

Each country has specific national requirements for information on the labeling and in the instructions for use (leaflet). In many countries, packaging mock-ups and instructions are compiled according to the language and technical requirements, are submitted as part of the registration dossier, undergo expert evaluation and are approved as an integral part of the marketing authorization. Inconsistency in packaging or instructions for approved mock-ups can lead to suspension of imports, additional testing, or even recall of the batch.

To develop (localize) and control the quality of information on labeling in all countries, we have our own local internally trained employees with high qualifications, experience, knowledge of national legislation and language. All activities are coordinated by the design department of our Head office, whose specialists communicate with the Customer, verify and design layouts, and control the quality and timescales of work.

We offer the following services:

  • development (localization) of labeling and/or instructions for use (package insert / leaflet) for one or more markets;
  • pre-printing assessment of compliance of packaging layouts and/or instructions with approved documents;
  • filling the Application and applying for variations to the approved documents;
  • assistance with quality control during import.

 

National requirements in brief:

Azerbaijan  The state language is Azerbaijani. The registration dossier contains instructions for medical use in Azerbaijani, as well as labeling of the packaging in Azerbaijani or Russian. Labeling and instructions undergo expert evaluation during the registration process, and are approved as annexes to the marketing authorization. Changes to the data on the labeling or in the instructions are subject to change.
Armenia The official language is Armenian. The registration dossier contains instructions for medical use and labeling of the packaging in Armenian, and/or in Russian, and/or in English. Labeling and instructions are examined during the registration process and are approved as annexes to the marketing authorization. Changes to the data on the labeling or in the instructions are subject to change.
Belarus The official languages are Belarusian and Russian. As part of the registration dossier labeling of the packaging, instructions for medical use and/or an insert leaflet in Russian or Belarusian are submitted. At the end of the registration procedure, an approved instruction and/or leaflet and packaging layout in colour with the seal of the state agency are issued. Changes to the data on labeling or in the instructions are subject to change.
Georgia The official language is Georgian. When registering under the recognition procedure, a packaging layout corresponding to that registered on the market of the reference country is submitted and approved; only instructions for use are translated into Georgian. When registering under the national procedure, the instructions for use are submitted and approved in Georgian, and the packaging labeling is submitted in Georgian and/or Latin and/or Slavic-Cyrillic, multilingual packaging is allowed to be registered. Approved packaging and instructions for medical use are posted on the website of the competent authority. Changes to the data on the labeling or in the instructions are subject to change.
Kazakhstan The official languages are Kazakh and Russian, while the status of the state language is only Kazakh. Labeling of the packaging and instructions for medical use are submitted to the competent authority, undergo an expert evaluation and are approved in Russian and Kazakh languages. The text of the instructions for use and samples of graphic design are approved after the registration procedure and are posted on the website. Changes to the data on the labeling or in the instructions are subject to change.
Kyrgyzstan The official languages are Kyrgyz and Russian, while only Kyrgyz is the state language. Labeling of the packaging and instructions for medical use are submitted to the competent authority, undergo an expert evaluation and are approved in Russian and Kyrgyz languages. The approved text of the instructions for medical use and the agreed layouts of the primary and secondary packaging are annexes to the marketing authorization. Changes to the data on the labeling or in the instructions are subject to change.
Moldova The official language is Moldavian, functioning on the basis of Latin graphics, and de jure identical to the Romanian language. The draft of leaflet is submitted, undergo an expert evaluation and is approved in accordance with the national form in Romanian. Packaging labeling is also filed and approved in Romanian. In agreement with the competent authority, for some hospital and socially significant medicinal products it is allowed to provide primary and secondary packaging in a language of international importance. Changes to the data on the labeling or in the instructions are subject to change.
Mongolia  The state language is Mongolian. The packaging labeling is submitted to the competent authority, undergo an expert evaluation and is approved in Mongolian, Russian and/or English. Instructions for use (leaflet) are submitted, undergo an expert review and approved in the Mongolian language. The labeling of the packaging and the instructions for use (leaflet) are part of the marketing authorization. Changes to the data on the labeling or in the instructions are subject to change.
Tajikistan The official languages are Tajik and Russian, while only Tajik has the status of the state language. The labeling of the packaging and instructions for medical use are submitted to the competent authority, undergo an expert evaluation and are approved in Russian and/or Tajik. Changes to the data on the labeling or in the instructions are subject to change.
Turkmenistan The state language is Turkmen. The labeling of the packaging and the instructions for medical use are submitted to the competent authority, undergo an expert evaluation and are approved in Turkmen and/or Russian and/or English. Changes to the data on the labeling or in the instructions are subject to change.
Uzbekistan  The official language is Uzbek. The labeling of the packaging and instructions for medical use are submitted to the competent authority, undergo an expert evaluation and are approved in Uzbek and Russian. Changes to the data on the labeling or in the instructions are subject to change.
Ukraine The official language is Ukrainian. The text for labeling the packaging and instructions for medical use are submitted to the competent authority, undergo an expert evaluation and are approved in Ukrainian. Based on the approved text for labeling colour layouts of the primary and secondary packaging are developed and submitted according to a separate procedure for inclusion in the information system of the competent authority. Changes to the data on the labeling or in the instructions are subject to change.

Cratia Ltd. performs expert work on the development, localization and quality control of packaging materials and instructions for use (leaflet) in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources to carry out the work.

To start cooperation or get advice, please contact us by phone: +38 044 361-48-28, +38 044 221-71-29, by e-mail: info@cratia.ua, or visit our office

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(name, formulation, dose and route(s) of administration, date of therapy start)