Cphem | Міністр охорони здоров'я РК наказом від 30 травня 2022 року вніс зміни до правил маркування лікарських засобів та медичних виробів.

The rules for labeling medicines have changed


The Minister of Health of the Republic of Kazakhstan, by order dated May 30, 2022, amended the rules for labeling medicines and medical devices.


In particular, the conceptual apparatus of the rules has been expanded. Also, the document has been added which medicines can not be labeled with identification means.
Added new paragraphs regulating:

  • the procedure for the formation of means of identification;
  • the procedure for applying means of identification;
  • aggregation of medicines labeled with means of identification;
  • the procedure for traceability of medicinal products labeled with means of identification.

Thus, it is allowed to apply on the packaging of the medicinal product:

  • holographic and security signs, duplication of the marking text using the Braille alphabet (for persons with visual impairments), symbols or pictograms that help explain information to the consumer;
  • the text of the instructions for medical use on the packaging of a medicinal product dispensed without a doctor's prescription;
  • additional marking text in foreign languages, provided that the information is completely identical;
  • barcode (if available).

At the same time, the color design of the packaging design of a medicinal product of the same dosage form containing different amounts of active substances is different.

The order comes into force on August 6, 2022. See the full text of the document at https://pharmnewskz.com/en/legislation/prikaz--r-dsm---49-ot-30-maya-2022-goda_6305

https://pharmnewskz.com/