Import Permit

Meet our team at these upcoming events

    KIMES, 33rd Korea International Medical & Hospital Equipment Show 
    March 16-19, 2017 | Korea, Soul

    Health Week in the Kyrgyz Republic «MedExpo 2017» 
    April 4-6, 2017 | Kyrgyzstan, Bishkek

    The 5th International Congress KAMLD
    April 14-15, 2017 | Kazakhstan, Almaty

    23rd Kazakhstan International Healthcare Exhibition - KIHE 2017 
    May 17-19, 2017 | Kazakhstan, Almaty

    III Russian Congress of Laboratory Medicine 
    October 11-13, 2017 | Russia, Moscow

    II International Dental Exhibition CADEX-2017 
    October 19 - 21, 2017 | Kazakhstan, Almaty

    14th Kazakhstan International Exhibition "AstanaZdorovie" 
    November 1-3, 2017 | Kazakhstan, Astana

    9th International Congress of KARM 2017 
    November 10-11, 2017 | Kazakhstan, Astana

    MEDICA - World Form for Medicine 
    November 13 - 16, 2017 | Germany, Düsseldorf

    27th International Healthcare Exhibition-2017 
    December 4-8, 2017 | Russia, Moscow

Import procedure for medicines, medical devices, and medical equipment

To obtain an import permit for medicines, medical devices, medical equipment registered in the territory of the Republic of Kazakhstan, the applicant shall provide the authorized body or its regional division with the following documents:

1)         when importing registered medicines, medical devices, medical equipment:

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 2 to these Regulations;
  • a copy of a pharmaceutical activity license stating the subtype of the activity associated with production of medicines, medical devices, medical equipment or with whole sale of medicines, medical devices, medical equipment, or a copy of a medical activity license;
  • a copy of the contract (agreement) with specification stating the manufacturer and the country of origin of medicines, medical devices, medical equipment;
  • a copy of the State Registration (Re-registration) Certificate as an individual entrepreneur for individuals or a copy of the State Registration (Re-registration) Certificate for legal entities; a copy of a document issued by the manufacturer or his authorized representative confirming distribution rights for import of medicines, medical devices, medical equipment from the territory of the third country translated into the state and Russian languages;
  • a copy of a certificate confirming the manufacturing site compliance with requirements of the Good Manufacturing Practice stating the date of the last inspection with translation into the state and Russian languages (in case of import of non-registered medical substances produced under the Good Manufacturing Practice);

2)         when importing registered medicines, medical devices, medical equipment as humanitarian help:

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 2 to these Regulations;
  • a copy of statutory documents and the State Registration (Re-registration) Certificate as an individual entrepreneur for individuals or a copy of the State Registration (Re-registration) Certificate for legal entities;
  • a letter from any local public health departments in the regions, the city of republican status and the capital or any health care organizations under the jurisdiction of the authorized body in the field of health care about the support of a humanitarian action with liability to control target non-commercial use of the cargo;
  • a document confirming humanitarian nature of the cargo (a gift deed, an agreement) translated into the state and Russian languages;
  • a document (a specification, an invoice) translated into the state and Russian languages confirming entry of medicines to the recipient address stating a manufacturer, a country of origin, a form of presentation, quantity, expiration date;
  • the plan for intended use (distribution) of humanitarian help;
  • list of the documents submitted.

To execute an import license for medicines, medical devices, medical equipment not registered in the territory of the Republic of Kazakhstan, the applicant shall provide the authorized body with the following documents:

1)         when importing samples of medicines, medical devices, medical equipment for state registration, re-registration and amendments to the registration dossier:

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 3 to these Regulations;
  • a commitment to provide these samples for state registration, re-registration and amendments to the registration dossier in the territory of the Republic of Kazakhstan;
  • calculation of quantity of medicines, medical devices, medical equipment approved by the state expert organization in the field of medicines, medical devices, medical equipment; a copy of an invoice translated into the state and Russian languages; a list of documents submitted.

2)         when exhibiting any medicines, medical devices, medical equipment without any sale rights;

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 3 to these Regulations;
  • a guarantee letter issued by the exhibition promoter specifying the applicant as an exhibitor; a copy of a contract (an agreement) or an invoice translated into the state and Russian languages; a list of documents submitted.

3)         in case of any individual treatment of rare and (or) severe diseases:

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 3 to these Regulations;
  • a copy of a pharmaceutical activity license stating a subtype of the activity associated with production of medicines, medical devices, medical equipment or with whole sale of medicines, medical devices, medical equipment, or a copy of a medical activity license;
  • a copy of a medical activity license for a health care organization (in case of import of any medicines, medical devices by a health care organization);
  • a copy of the State Registration (Re-registration) Certificate as an individual entrepreneur for individuals or a copy of the State Registration (Re-registration) Certificate for legal entities; a letter from any local public health departments in the regions, the city of republican status and the capital or any health care organizations under the jurisdiction of the authorized body in the field of health care including verification and calculation of the quantity of medicines, medical products; a copy of a contract (an agreement) or an invoice translated into the state and Russian languages; a list of documents submitted.

4)         to prevent and eliminate any consequences of emergencies:

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 3 to these Regulations;
  • of the State Registration (Re-registration) Certificate for legal entities;
  • a copy of a contract (an agreement) or an invoice (a bill of landing) translated into the state and Russian languages;
  • a letter from local executive bodies referring to the emergency situation; a list of documents submitted. 8771134277

5)         when any unique medical equipment registered and having no alternatives in the Republic of Kazakhstan is supplied to health care organizations:

  • an application to get an import permit in hard copy or on electronic media according to the form in Appendix 3 to these Regulations;
  • a copy of the State Registration (Re-registration) Certificate as an individual entrepreneur for individuals or a copy of the State Registration (Re-registration) Certificate for legal entities; a copy of a pharmaceutical activity license stating the subtype of the activity associated with the bulk sale of medical equipment;
  • a copy of a medical activity license for the health care organizations (in case of import of medicines, medical devices by a health care organization);
  • a copy of a contract (an agreement) or an invoice (a bill of landing) translated into the state and Russian languages;
  • an opinion of a state expert organization in the field of medicines, medical devices and medical equipment registered in the Republic of Kazakhstan.

To obtain an opinion about uniqueness and unavailability of alternatives of medical equipment registered in the Republic of Kazakhstan, the applicant shall provide the state expert organization in the field of medicines, medical devices and medical equipment with the following documents:

  • a document certifying the registration of medical equipment in the country of origin and (or) Free Sale Certificate;
  • a document confirming compliance of the manufacture site with the national and (or) international standards (GMP, ISO, EN);
  • a document confirming compliance of medical equipment with national and international regulatory documents (Compliance Statement or Certificate of Compliance) of the seller's country; a technical specification stating any technical characteristics, a list of main components/ parts and consumables;
  • results of clinical trials and (or) studies;
  • an operation manual for the medical equipment in the state and Russian languages; color photos 13x18 cm (with the appearance of the article, components and consumables); information on the manufacturer containing: the name, a type of the activity, registered address, form of ownership, a list of divisions, branches and a service center stating their status and powers; a list of documents submitted.

6)         for clinical trials and (or) studies:

  • an import permit application for medicines, medical devices, medical equipment in hard copy or on electronic media according to the form in Appendix 3 to these Regulations;
  • a copy of the State Registration (Re-registration) Certificate as an individual entrepreneur for individuals or a copy of the State Registration (Re-registration) Certificate for legal entities; a copy of a contract (an agreement) or an invoice (a bill of landing) translated into the state and Russian languages;
  • a copy of the order issued by the authorized body to permit a clinical trial for medicines, medical devices, medical equipment;
  • copies of manufacturer's documents confirming the quality of medicines, medical devices, medical equipment intended for medical trials and (or) studies; a list of documents submitted.

The documents stated in clauses 5, 6 hereof shall be numbered, sewn together, sealed and signed by the applicant or its representative.

The authorized body shall keep accounts of the import permits issued for medicines, medical devices, and medical equipment.

Only medicines, medical devices, medical equipment in package approved during the state registration can be imported.

Upon amendment of the registration dossier changing the labeling and package of medicines, medical devices, medical equipment, import of goods in the previous package shall be forbidden except for medicines imported to the territory of the Republic of Kazakhstan earlier and being under the “Customs warehouse” regime.

Any importation of medicines, medical devices and medical equipment by individuals for personal use in quantities required for a course of treatment shall be carried out without any permission of the authorized body.

Any license permit may be revoked in case of violation of requirements set out herein.

Revocation of any license can be protested in accordance with a juridical procedure.