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Registration/re-registration of medicines
Registration/re-registration of medicines
State registration and re-registration are subject to medicines manufactured in the Republic of Kazakhstan, as well as imported into its territory, registered in the producing country, including:
Medicinal products under trade names indicating the dosage form, dosage, packaging;
Bulk-medicinal products imported into the Republic of Kazakhstan;
New combinations of medicines previously registered in the Republic of Kazakhstan with indication of dosage form, dosage, packaging;
Medicines registered earlier in the Republic of Kazakhstan, but produced by other manufacturing organizations in other dosage forms with a new dosage, new packaging, new packaging, a different composition of excipients, a different name.
State registration is not subject to:
medicinal products and radiopharmaceutical medicinal products manufactured in pharmacies or in pharmacies for the production of medicines in medical organizations;
medicinal substances produced under conditions of good manufacturing practice;
More than 70 types of documentation
from certificates of conformity to registration of medicines and medical devices