New reality – acceleration of pharmaceutical products access to Kazakhstan market
Regulation of Kazakhstan pharmaceutical market is rather dynamic, especially in the past years. The 2020 has also become a year of changes. Apart from anticipated planned amendments, including adoption of a new Kazakhstan Code of Health of Population and Healthcare System, other amendments are being introduced triggered by COVID-19 pandemic.
As such, in June – July 2020 a number of amendments were adopted to the regulation aimed at ensuring sufficiency of medicines and medical items as well as accelerating their access to Kazakhstan market.
In general, accelerated access is envisaged in the following two special occasions:
· arrangement and application of sanitary antiepidemic and sanitary preventive measures and related restrictive measures including quarantine (Special Measures); and
· provision of humanitarian aid and (or) elimination of consequences of emergency situations.
These amendments concern various stages of the entire process of access of medicines and medical items, both registered and unregistered, to Kazakhstan market.
Please see a brief overview of such major amendments further below.
1) Expertise
(a stage preceding, inter alia, state registration of medicines/ medical items)
Unlike under the standard procedure, in case of arrangement and application of the Special Measures neither assessment of production conditions, nor laboratory trials in a quality control laboratory of a producer or contract laboratory used by a producer are conducted.
This amendment substantially decreases the general term of expertise of medicines/ medical items for the purpose of state registration and accordingly supports quicker access of medicines/ medical items in the abovementioned special occasion.
By way of example, under the standard procedure of expertise of medicines for the purpose of state registration, the term of laboratory trial is 70 calendar days, whereas the term of preparation of a safety, efficiency and quality conclusion is 20 calendar days.
2) Safety and quality assessment
(a procedure applied in relation to registered medicines/ medical items for granting access to the market)
Unlike under the standard procedure, in case of arrangement and application of the Special Measures the expedite procedure of safety and quality assessment by way of declaration is envisaged. Access to the market by way of declaration does not require conduct of trial of product samples, making a report on assessment of production conditions and quality control system as well as other steps applied under the standard assessment procedure.
This amendment also supports quicker access of imported medicines/ medical items to the market in the abovementioned special occasion as the term of such expedite procedure is 3 business days as of the date of receipt of respective application.
3) Permit for import
(a procedure applied to import of registered medicines/ medical items as well as unregistered ones in cases envisaged by the Kazakhstan Government)
List of documents filed (for obtaining a permit document) has been changed in respect of cases when medicines/ medical items are imported for the purposes of provision of humanitarian aid and (or) elimination of consequences of emergency situations. For instance, in such special occasions (grounds for import) such documents as electronic copy of a document confirming humanitarian status or electronic copy of a plan of dedicated use (distribution) of humanitarian aid are no longer required for obtaining of a permit document for import.
4) Procurement for retail sale
The Uniform Distributor SK-Pharmacy LLP, being authorized to make procurement of medicines/ medical items within wholesale market, is now also authorized to make wholesale procurement of medicines/ medical items for subsequent sale in retail chain. This power has been granted until 31 December 2020 inclusive.
This amendment is aimed at securing additionally required volumes of medicines/ medical items in retail chain (pharmacies) not only by producers and private wholesale distributors but by the Uniform Distributor too.
It should be noted that the aforementioned amendments to the regulation are worded widely as regards to the purpose of use of medicines/ medical items. In the absence of express directions, the introduced expedite or simplified procedures may potentially apply to any medicines/ medical items, but not necessarily to those used for treatment of coronavirus infection.
That said, it is of interest to note that according to information published at the Uniform Distributor’s website the said new power is granted to the Unified Distributor “only in relation to medicines included into clinical protocol for treatment of the coronavirus infection”.
Having extensive and longstanding experience in advising Kazakhstan pharmaceutical market participants, we will be happy to assist you on the abovementioned matters as well as any other matters in this industry.
Contact details
Akylbek Kussainov, Partner, akylbek.kussainov@zanhub.com
Ilmira Yuldasheva, Counsel, ilmira.yuldasheva@zanhub.com
