lsAccording to the Order of Minister of Healthcare of the Republic of Kazakhstan No.735 dated November 18, 2009 – On approval of Rules of state registration, re-registration and making amendments to registration dossier of medicine, medical products and equipment, the following products, registered and permitted for medical use in the RK, shall be subject to inclusion in the State register:

  • medicines;
  • drug substances;
  • bulk products;
  • medical products;
  • crude medicine of natural origin (including medicinal plants);
  • parapharmaceutical products;
  • homoeopathic medicines.
  • medical equipment;
  • medical immunobiological preparations.

lsIt should be noted that the State register is based on results of carried out work, different instances: Ministry of Healthcare: National Center for Expertise of Medicines, Medical Devices and Medical Equipment Republican State Enterprise and its structural subdivisions; Medical and Pharmaceutical Activities Control Committee.

The following information on medicines shall also be included in the State register:

  • registration number;
  • No. of Order of the Medical and Pharmaceutical Activities Control Committee (registration, re-registration and making amendments);
  • type of registration;
  • term of registration;
  • date of registration expiration;
  • shelf life;
  • trade name;
  • manufacturer, country;
  • type of medicine;
  • INN (International Nonproprietary Name);
  • composition of actual substances;
  • International Anatomical Therapeutic Chemical Classification;
  • pharmaceutical form;
  • dosage or concentration;
  • filling and package designs;
  • administration methods;
  • pharmacy purchasing terms;
  • belonging to checklists (narcotic drugs, psychotropic substances and precursors);
  • signs of original or reproduced medicine, GMP, patent and trademark;
  • data on the normative document;
  • Guideline for medical use.

lsThe following data on medical preparations and equipment can be found in the register:

  • registration number;
  • No. of the Order of the Medical and Pharmaceutical Activities Control Committee (registration, re-registration and making amendments);
  • type of registration;
  • term of registration;
  • date of registration expiration;
  • shelf life;
  • trade name;
  • manufacturer, country;
  • type of medicine;
  • safety class;
  • prescription;
  • field of application;
  • brief technical characteristics;
  • completeness;
  • filling and package designs;
  • signs of medical equipment or medical products, GMP, patent and trademark;
  • Guideline for medical use.

Conduction of registration is possible only after expertise, which consists of 3 stages:

  1. Checking the provided documents, which allow consideration of the medicine as orphan.
  2. Checking and processing of methods aimed at quality control of the medicine and directly control in accordance with these methods.
  3. Establishment of correlation between the expected benefit of the medicine and possible risks from its action.

A separate dossier during registration is submitted for each medicine. Simultaneous consideration of one medicine at different dosages, volumes and concentrations is allowed within the same dossier. We provide such services as:

  • Consultation on the issues related to registration of medical products and equipment;
  • Creation, collection and keeping of registration dossiers according to requirements;
  • Development of the list of documents;
  • Production of certain documents for registration;
  • Adaptation of documents provided by the partner/client, in accordance with the law of the Republic of Kazakhstan;
  • Creation of original and secondary package design;
  • Submission of the dossier to the responsible government authority, which conducts the state registration of medicines, equipment and other medical products;
  • Carrying out the kinetics and dissolution test;
  • Conduction and control over different pre-clinical and clinical studies of the medicine;
  • Arrangement of receipt of official requests, permissions and decisions;
  • Preparation and collection of additional materials;
  • Obtainment of a registration certificate and agreed documents for a medical device.

We also provide such services as:

  • Conduction of confirmation of state registration or re-registration of medicines;
  • Making amendments to the registration dossier in accordance with requirements;
  • Registration of biologically active additives and materials for its production;
  • Introduction of pharmaceutical substances in the State Register of the Republic of Kazakhstan.
Permission for import of medicine/medical products, equipment and their registration in the RK
from 1 000 000 tenge

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