On June 20, the Single Distributor held a joint meeting with the Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan with the participation of Atameken NCE of RK, industry associations and business representatives, where topical questions of certificates’ issuing of origin for ST-KZ internal circulation and contract manufacturing of medicines.
The discussion was attended by the Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan, Chairman Abenov A.D., Deputy Chairman Elikbaev K.N., from Atameken NCE - Managing Director-Director of the Department of Medical Services Kabdrakhmanova N.M., Managing Director-Director of the Department of Certification of the Origin of Goods Kusainov A.K., Deputy Director of the Department of Certification of the Origin of Goods Sadykov S.S., Deputy Director of the Department of Procurement and Local Content Shokaev R.T., expert of the 1st category of the Department of Procurement and Local Content Alinova A. N., expert of the Department of Medical Services Erezhepova A.S.
On the part of industry associations there were the executive director of the Union of Domestic manufacturers of medical devices, Medindustry of Kazakhstan medical products ALE Nurmukhanov R.A., Executive Director of the PharmMedIndustry of Kazakhstan Association of Manufacturers of Pharmaceutical and Medical Products of Kazakhstan ALE Manakpayeva G.D., Chairman of the Association of Manufacturers of Medical Devices ALE Mukhamedzhanova G.E., President Association of expert organizations in the field of technical regulation ALE Zverev D.S.
From the business side there were representatives of Karaganda Pharmaceutical Complex LLP - General Director Baron S.A., Executive Director Agatanov E.B., Head of the Development Department Eremin D.V., Head of the Legal Department Tolegenova B.
To date, the ST-KZ certificate is one of the documents confirming that the goods are manufactured in Kazakhstan, and representing preferences from the state in the form of a 10-year off-take contract for the supply of medicines and medical devices under the SVFMC and SCSHI.
At the same time, the ST-KZ certificate is included in the list of mandatory documents for deliveries under long-term supply contracts with contract manufacturing customers of original, patented medicines.
The meeting participants discussed the current situation and problematic issues with obtaining certificates in the production of medicines and medical devices, including for the development of contract manufacturing.
Single Distributor focused the attention of the meeting participants that the ST-KZ certificate not only confirms that the product is produced in Kazakhstan, but also allows you to determine the level of localization depth of any product (the share of local content), which is an important criterion for the level of development of the pharmaceutical industry.
Chairman of the Committee for Technical Regulation and Metrology Ministry of Trade and Integration of the Republic of Kazakhstan Abenov A.D. noted the willingness of the Committee to consider the consolidated proposals of the Single Distributor, industry associations and businesses to amend the Rules for determining the country of origin of goods.
Representatives of business and industry associations voiced the main fundamental issues on the topic of the meeting: a list of technological operations for pharmaceutical production, requirements for the safety, quality and effectiveness of manufactured medicines, the need to develop and approve an examination methodology for expert auditors, the importance of regulatory consolidation of the phasing of deepening the level of localization etc.
The meeting participants unanimously agreed on the need to restart the process of issuing the ST-KZ certificate in the pharmaceutical industry with the development of specific proposals for the current regulatory legal acts.
Based on the results of the discussion, it was decided to prepare a set of agreed proposals for amending the Rules for determining the country of origin of goods and send them for consideration to the Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan.
Reference:
Certificate of origin of goods is a document certifying the country of origin of the goods, the status of the goods of the Eurasian Economic Union or foreign goods;
Country of origin of the goods is the country in which the goods were completely produced or subjected to sufficient processing / recycling;
Expert auditors for determining the country of origin of goods, the status of goods of the Eurasian Economic Union or foreign goods are individuals certified by the the Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan;
The Ministry of Trade and Integration of the Republic of Kazakhstan, in accordance with subparagraphs 7-2), 7-3) of Article 7 of the Law of the Republic of Kazakhstan "On the regulation of trading activities", is determined by the authorized state body for the development and approval of rules for determining the country of origin of goods, the status of goods of the Eurasian Economic Union or foreign goods, the issuance of a certificate of origin of goods and the cancellation of its validity, and also establishes the forms of the certificate to determine the country of origin of goods.
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