For the last two months, the Government of Uzbekistan has
adopted a number of new legislative acts that have significantly
amended the regulatory environment of the pharmaceutical business
in Uzbekistan. The overall intention of the Uzbek Government is to
stimulate local production of pharmaceuticals by providing local
producers with a more favorable tax, customs and sales regime as
well as to ensure the population of Uzbekistan has access to
INN in Prescriptions and Recommendations to Buy Local
The Minister of Public Health of Uzbekistan issued an order
No.2118-2 dated September 23, 2016 on amendment of the Regulation
on prescription of pharmaceuticals1.
According to these changes, when prescribing pharmaceuticals
attending medical doctors have to fill in prescriptions by
indicating only the international nonproprietary names (INN) of
pharmaceuticals without using their branded names. The
exception is made for complex pharmaceuticals that have more than
one INN as part of their composition.
Additionally, pharmacies are now recommended to offer patients
pharmaceuticals of local production prior to offering medicaments
of foreign production for the purpose of supporting local
producers. Along with the Presidential Decree No. 2647
(below) instructing the Ministry of Public Health to
revise and amend diagnosis and treatment standards as well as
clinical guidelines so that to provide for the primarily use of
pharmaceuticals of local production, this recommendation clearly
signals that the Government of Uzbekistan will actively support
The changes adopted by the Ministerial Order shall enter into
force on December 26, 2016. Yet, it will be required to monitor the
practical implementation of these changes as well as to see how
discrimination claims will be tested in courts.
Price Fixing and Maximum Trade Mark-up
Presidential Decree No.ПП-2647 dated October 31,
2016 sets new maximum trade mark-ups applicable for sale of
pharmaceuticals. The wholesale mark-up shall not be more than 15%
on the purchase price and the retail mark-up shall be not more than
20% on the wholesale price. The mark-ups are applicable without
regards to the number of intermediates within the supply chain.
The Decree provides for making the List of Social Significant
Pharmaceuticals that will be sold at fixed prices. The prices will
be set by the special Republican Commission. Pharmaceuticals of
foreign production included in the List will be purchased on tender
basis among local wholesale and wholesale and retail trade
companies. The tenders shall be conducted by the Ministry of
Foreign Economic Relations, Investments and Trade of
The new pricing rules will enter into force starting from
January 1, 2017.
Tax and Customs Incentives for Producers of
Presidential Decree No. ПП-2595 dated September 16,
2016 establishes that companies specializing in production of
pharmaceuticals – not less than 60% of the overall turn-over
– are exempted from the following taxes until January 1,
Corporate Income Tax;
Unified Tax Payment;
Mandatory Payments to the Republican
Moreover, equipment, accessories and spare parts that are not
produced in Uzbekistan and are imported for the purpose of
implementation of investment projects in the pharmaceutics sphere,
the list of which is approved by the Government of Uzbekistan, are
exempted from customs payments, excluding the customs clearance
Drug Product Safety Technical Regulations
General Technical Regulations on safety of pharmaceutical
products was adopted by the Cabinet of Ministers of Uzbekistan No.
365 dated October 27, 2016. The Technical Regulations bring
together all the requirements on safety of the drugs during their
development, production, transportation, storage, sale and
destruction in one document.
The Regulations also provide detailed description of the
packaging and labelling requirements for pharmaceuticals, which
have certain deviations from the current requirements.
These Regulations will enter into force on April 30, 2017. Upon
entrance into force of the Regulations, all previously adopted
policies, standards, and requirements lose their mandatory force
and become voluntary.
1 Regulation on procedure for prescription of
pharmaceuticals and acceptance, storage and usage of
pharmaceuticals of patients in medical and preventive treatment
facilities as well as sale of pharmaceuticals to the population
based prescriptions by pharmacies No.2118 dated June 29,
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
The key pieces of legislation governing the authorisation, marketing, sale and supply of pharmaceutical products in Mauritius are the Pharmacy Act 1983 and the Consumer Protection (Price and Supplies Control) Act of 1998.
Apart from feeble attempts by health authorities and efforts of charitable organizations, little has been done in Nigeria and a host of underdeveloped and developing economies to tackle the issue of mental health and indeed the law governing that very field of Medicare.
The pharmaceutical and healthcare sector in the GCC region has over the past few years enjoyed one of the most robust growth rates in the world...
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).