Document from CIS Legislation database © 2003-2022 SojuzPravoInform LLC

The document ceased to be valid since  February 13, 2016 according to Item 1 of the Order of the Government of the Republic of Kazakhstan of January 27, 2016 No. 31

ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of May 31, 2012 No. 711

About approval of Rules of import and export of medicines, products of medical appointment and medical equipment

(as amended on 31-12-2013)

According to articles 80 and 81 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve enclosed:

1) Rules of import of medicines, products of medical appointment and medical equipment;

2) Rules of export of medicines, products of medical appointment and medical equipment.

2. This resolution becomes effective after ten calendar days after the first official publication.

Prime Minister of the Republic of Kazakhstan

K. Masimov

Approved by the Order of the Government of the Republic of Kazakhstan of May 31, 2012 No. 711

Rules of import of medicines, products of medical appointment and medical equipment

1. General provisions

1. These rules of import of medicines, products of medical appointment and medical equipment (further - Rules) are developed according to article 80 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system".

2. These rules determine procedure for import of medicines, products of medical appointment and medical equipment to the Republic of Kazakhstan.

3. Import of medicines and pharmaceutical substances (further - medicines) from the states which are not state members of the Customs union is performed according to the Regulations on procedure for import to customs area of the Customs union of medicines and pharmaceutical substances approved by the decision of Board of the Eurasian economic commission of August 16, 2012 No. 134.

4. In these rules the following basic concepts are used:

1) proper production practice - the national standard in the sphere of drug circulation, products of medical appointment and medical equipment establishing requirements to production organization, production process and monitoring procedure in case of production of medicines, products of medical appointment and medical equipment;

2) the document confirming humanitarian character of freight in the address poluchatelyasoglasheniye, invoice (delivery note), the invoice, the agreement (contract), the specification with indication of information on gratuitousness of freight, producer, the manufacturing country, release form, quantity, expiration date;

3) the plan of target use (distribution) of the humanitarian assistance - the document approved by the head of the organization of health care, containing information on terms, the place, the name, the number of distribution of the humanitarian assistance;

4) the operational document of medical equipment - the operation manual, the passport of medical equipment;

5) the registration file - the set of documents and materials of the established content represented together with the statement on state registration, re-registration of medicine, products of medical appointment and medical equipment and modification of the registration file.

2. Procedure for import of medicines, products of medical appointment and medical equipment

Import of medicines

5. When importing to the territory of the Republic of Kazakhstan of medicines from the states which are not state members of the Customs union, their room is performed under customs procedures according to the decision of Board of the Eurasian economic commission of August 16, 2012 No. 134.

6. Import of medicines, including from the states which are not state members of the Customs union (including unregistered) in non-commercial purposes for private use by physical persons, workers of diplomatic corps or representatives of the international organizations, for treatment of passengers and members of crews of the vehicles, crews of train and transport drivers who arrived to customs area of the Customs union for treatment of participants of the international cultural, sporting events and participants of the international expeditions is performed without the permission of authorized body.

7. Execution of the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the unregistered medicines (including when importing the unregistered medicinal substances made in the conditions of proper production practice), the registered medicines intended for clinical trials, the humanitarian assistance (assistance) or the help in case of emergency situations and coordination of the medicines registered in the Republic of Kazakhstan is performed by authorized body or its territorial subdivisions in form, according to appendices 1, 2 and 9 to these rules.

8. For execution of the conclusion (the allowing document), coordination on import of the medicines registered in the territory of the Republic of Kazakhstan the applicant submits the following documents to authorized body:

1) for performing clinical trials and (or) testing:

statement;

the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;

the copy of the agreement (contract) or invoice (delivery note) with the translation into the state or Russian languages;

the copy of the order of authorized body on permission of performing clinical trials of medicines;

copies of the documents of the producer confirming quality of the medicines intended for performing clinical trials;

the inventory of the submitted documents;

2) for humanitarian assistance:

statement;

the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;

the letter of local authorities of public administration by health care of areas, the cities of republican value and the capital or the organizations of health care having the license for medical activities about support of this humanitarian action with the obligation on control of target non-commercial use of freight;

the document confirming humanitarian character of freight to the receiver with the translation into the state or Russian languages;

plan of target use (distribution) of the humanitarian assistance;

the inventory of the submitted documents;

3) for prevention and/or elimination of consequences of emergency situations:

statement;

the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;

the copy of the agreement (contract) or invoice (delivery note) with the translation into the state or Russian languages;

the letter from local executive bodies on emergency situation;

the inventory of the submitted documents.

For review import of the medicines registered in the territory of the Republic of Kazakhstan (except for subitems 1-3 of Item 8) the applicant submits the following documents to territorial subdivisions of authorized body:

statement;

the copy of the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines or with wholesale of medicines or the copy of the license for implementation of medical activities by the organizations of health care (in case of import of medicines by the organization of health care);

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.