Labeling requirements and artwork registration

The registration dossier for new marketing authorization or renewal must contain suggested text for labeling of the package. 

The language of the labeling is Ukrainian; other languages are also allowed. Suggested information undergoes an expert assessment and is approved as integral to a marketing authorization certificate.

After receiving the marketing authorization, but before importing a medicinal product, the MAH develops primary and secondary packaging graphic layouts (artworks) and submits them for registration in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC).

At the stage of batch quality control during import, the packaging undergoes a visual inspection. The slightest discrepancy can lead to the suspension of a conclusion on the quality, the need for laboratory batch quality control, or other corrective actions.

The exceptions are medicines purchased by specialized organizations and vaccines that have received emergency use authorization, which can be supplied in the original packaging from the reference market.

Labeling text

The labeling language is Ukrainian (other languages are also allowed). Suggested labeling information is submitted as part of the registration dossier, undergoes an expert assessment during which changes can be made, and is approved as the integral annex to the marketing authorization certificate.

The information must be provided in Ukrainian (other languages are also allowed) and should contain:

• name of the medicinal product;
• quantity of active substance(s);
• list of excipients;
• pharmaceutical form and contents of the container;
• method and route(s) of administration;
• special warning that the medicinal product must be stored out of sight and reach of children;
• another special warning(s), if necessary;
• expiry date;
• special storage conditions;
• special precautions for disposal; 
• name and address of the manufacturer responsible for the batch release;
• marketing authorization number(s);
• prescription status (OTC or Rx);
• instructions on use for medicines intended for self-treatment;
• information in braille;
• other information that may be useful to the patient (advertising information is not allowed).

There are additional requirements for labeling certain types of medicines, for example, radiopharmaceuticals and narcotics.

Graphic layouts and its registration 

After receiving the marketing authorization, but before importing a medicinal product, the MAH develops graphic layouts of primary and secondary packaging and submits them for registration in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC).

A large number of requirements are imposed on the registered packaging layouts. In particular, it is necessary to indicate the size (dimensions) of the packaging, printing inks used in the production of packaging, technical elements and graphic elements and their arrangement, etc.

Changes to the approved text or description of the packaging system are made by submitting an Application for variations and the corresponding package of documents to the Ministry of Health. Changes in graphic images of packaging layouts (provided that the text remains unchanged) are submitted again for authorization in the UAIS of the SMDC.

Our services

Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.

We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner. 

We offer: 

• consultation, development of registration strategy;
• establishment of new registration, renewals, and variations;
• establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
• confirmation of manufacturing conditions with GMP requirements through recognition or inspection.

In addition to the main services, we also offer:

• translation of the scientific, medical, technical, and legal documentation;
• back-office operations: preparation of the registration dossier or any of its parts without submission;
• development and pre-printing verification of labeling artworks and instructions for use;
• medical writing of parts of the registration dossier;
• development of documentation and import licensing;
• writing of documentation for inclusion of the medicinal product in the National List (HTA).