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Labeling requirements

Labeling text undergo expertise during State registration and shall be approved as Addendum to Registration Certificate. After Registration Certificate obtaining, but before Pharmaceutical Product's import, Applicant has to create graphic mock-ups of packaging and to submit them for registration in the State Service of Ukraine on Medicines and Drugs Control (SMDC) Unified Automated Information System (UAIS).

Pharmaceutical Product's packaging is examined on the import of the batch stage (obtaining a conclusion on quality of imported batch), and even the smallest inconsistence can lead to deficiencies (observations), delay in issuing of the conclusion regarding the quality, and necessity of corrective actions.

Information has to be indicated on the packaging in the Ukrainian language, any other languages (e.g. Russian, English) may be present under the condition of identity to the Ukrainian text.

Exception is made only for Pharmaceutical Products, purchased by specialized international organizations, which allowed to be supplied in the packaging labeled in the source language.

 

Pharmaceutical Product's packaging shall include the following elements:

1.     Bar-code of medicinal product;

  1. Trade name of medicinal product, which is accompanied by INN indication (for monocomponent pharmaceutical products);
  2. If the trade name can be used in several pharmaceutical forms and/or can have different strengths - pharmaceutical form and/or strength shall be indicated, and shall be defined for who this medicinal product is designed (infants, children of one year old and upwards or for adults);
  3. Active ingredients in qualitative and quantitative aspects;
  4. Pharmaceutical form along with indication of mass, volume or number of dosage units in the package;
  5. List of excipients;
  6. Method and, if necessary, route of administration of pharmaceutical product;
  7. Special warnings and precautions that pharmaceutical product should be stored out of reach of children and out of sight, if necessary;
  8. Special warnings and precautions regarding the pharmaceutical product, if necessary;
  9. Expiration date (month/year);
  10. Special warnings and precautions as to what shall be done to unused pharmaceutical product or its wastes;
  11. Manufacturer's name and location and address and address where his activity takes place;
  12. Number of Registration Certificate;
  13. Batch number which assigned by manufacturer of pharmaceutical product;
  14. If pharmaceutical product is intended for self-treatment, information on its use;
  15. Storage conditions, special storage conditions, if necessary.

There are additional labeling requirements for specific pharmaceutical products labeling: homeopathic, radiopharmaceutical, narcotic, traditional.

Graphic presentation of primary and secondary packaging has to be composed using approved labeling text (Addendum to registration Certificate) and shall be submitted to SMDC for registration in UAIS.

Composed mock-ups, submitted for registration, shall contain:

-     approved text;

-     graphical presentation of exact text position and others elements of the package;

-     dimensions and contours of mock-ups;

-     graphical presentation and/or description of protective elements;

-     designation of printing colors, which will be used in the process of manufacturing;

-     labeling in Braille and their disposition (if applicable);

-     bar-code;

-     technical elements disposition;

-     other additional information (if necessary).

The secondary packaging (or primary, if secondary packaging is absent) shall contains Braille labeling in the Ukrainian language, excluding pharmaceutical products used by competent specialists: orphan pharmaceutical products, drugs for parenteral use, radiopharmaceutical products, specific immunobiological products). For these groups Braille labeling left to the manufacturer's decision.

Any amendments into the approved text or description of packaging system can be done after submitting of Application on modifications and appropriate set of documents to MOH. Graphic design of packaging mock-ups can be changed (under the stipulation that text remains unchanged) by submitting a new application to the SMDC for re-registration in the UAIS.

 

"Cratia" company professionally performs all the jobs on developing labeling text, creation the mock-ups of primary and secondary packaging of Pharmaceutical Products, mock-ups registering in the UAIS of SMDC. We are ready to offer a complete amount of work to comply with all the regulatory requirements or any of the dedicated options:

-     labeling text development.

-     graphical mock-ups creation;

-     checking of mock-ups before printing and/or before registration in the UAIS of SMDC;

-     submitting mock-ups and registration in the UAIS of SMDC.

 

For a start of cooperation or taking a consultation please call  +38 044 361-48-28, +38 044 221-71-29, send an email to info@cratia.ua or come and meet us in the office.