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Newsletter on Pharmaceutics for July 2019
This legal alert highlights the most important legal developments of July 2019 that affect the Uzbek pharmaceutical industry as a whole and activities of foreign pharmaceutical producers and their representative offices in Uzbekistan in particular.
1. LICENSES FOR MEDICAL AND PHARMACEUTICAL ACTIVITIES
A mechanism for fast track obtainment or renewal of pharmaceutical and medical licenses has been introduced. Thus, an applicant may now choose between the usual procedure taking 15 days for the pharmaceutical license and 20 days for the medical license and the fast track procedure – 5 days in both cases. The fast track mechanism is not available in case of the license for the retail sale of medicines and medical products;
Application fees are higher for fast track applications – 4 times the baseline calculation value for the pharmaceutical license and 5 times the baseline calculation value for the medical license (approximately, USD 94 and USD 117 respectively).
The fast track renewal of both categories of licenses takes 1 day and costs 2 times the baseline calculation value (approximately, USD 47).
Resolution of the Cabinet of Ministers No. 548 of July 2, 2019
Application fees are higher for fast track applications – 4 times the baseline calculation value for the pharmaceutical license and 5 times the baseline calculation value for the medical license (approximately, USD 94 and USD 117 respectively).
The fast track renewal of both categories of licenses takes 1 day and costs 2 times the baseline calculation value (approximately, USD 47).
Resolution of the Cabinet of Ministers No. 548 of July 2, 2019
2. EXPORT – IMPORT OPERATIONS
The formula for calculating the purchase price of imported medicines and medical products has been slightly changed. One element of the relevant equation, the exchange rate difference between the contract value on the date of conclusion of the relevant import contract and the contract value on the date of filling in cargo declarations, has been excluded.
Presidential Decree No. PP – 5759 of July 5, 2019
The Regulation on the Procedure for Receiving Foreign Currency in Cash on the Territory of the Republic of Uzbekistan has been supplemented. Cash foreign currency may now be accepted from foreign individuals repaying debts under foreign trade contracts.
In doing so, a foreign individual is required to have one of the following documents confirming the origin of cash foreign currency: (i) a passenger customs declaration proving the import of cash foreign currency or (ii) checks confirming the withdrawal of money from his bank account through ATMs or (iii) a statement from a local bank about the withdrawal of funds transferred from abroad from his local bank accounts.
Resolution No. 1165-9 of July 5, 2019
Presidential Decree No. PP – 5759 of July 5, 2019
The Regulation on the Procedure for Receiving Foreign Currency in Cash on the Territory of the Republic of Uzbekistan has been supplemented. Cash foreign currency may now be accepted from foreign individuals repaying debts under foreign trade contracts.
In doing so, a foreign individual is required to have one of the following documents confirming the origin of cash foreign currency: (i) a passenger customs declaration proving the import of cash foreign currency or (ii) checks confirming the withdrawal of money from his bank account through ATMs or (iii) a statement from a local bank about the withdrawal of funds transferred from abroad from his local bank accounts.
Resolution No. 1165-9 of July 5, 2019
3. E-HEALTH
Electronic prescriptions for medications will be introduced within 2 months. The electronic prescription will represent an electronic document containing doctor’s instructions for preparation or the dispensing of a medication, certified by a doctor’s electronic digital signature.
The Requirements for Buildings (Premises), Material and Technical Base for the Retail Sale of Medicines and Medical Products have been amended accordingly. Starting from October 2, 2019, pharmacies and their branches will have to be equipped with a computer or similar equipment that has regular access to the Internet.
The Regulation on the Retail Sale of Medicines and Medical Products has also been amended. It will be allowed to sell non-prescription medicines online. The sale of narcotic medicines, psychotropic medicines and precursors is prohibited. There are some specific requirements for the delivery of medicines sold online. Violation of e-commerce rules may lead to the termination of the license for the retail sale of medicines and medical products. Relevant rules will enter in force within 2 months.
Resolution of the Cabinet of Ministers No. 549 of July 2, 2019
The Requirements for Buildings (Premises), Material and Technical Base for the Retail Sale of Medicines and Medical Products have been amended accordingly. Starting from October 2, 2019, pharmacies and their branches will have to be equipped with a computer or similar equipment that has regular access to the Internet.
The Regulation on the Retail Sale of Medicines and Medical Products has also been amended. It will be allowed to sell non-prescription medicines online. The sale of narcotic medicines, psychotropic medicines and precursors is prohibited. There are some specific requirements for the delivery of medicines sold online. Violation of e-commerce rules may lead to the termination of the license for the retail sale of medicines and medical products. Relevant rules will enter in force within 2 months.
Resolution of the Cabinet of Ministers No. 549 of July 2, 2019