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Adocacy achievements of the week

05/ 02/ 2021
  We are extremely pleased to announce that this week has been fruitful for good news and long-awaited positive decisions. We can boast of two solutions in favor of the healthcare industry, as well as achievements in the food, regulatory, veterinary, agrochemical, and electronic payments industries, in brief: Veterinary legislation has been significantly updated for the first time in Ukraine On February 4, the Verkhovna Rada adopted, the draft Law №3318 On Veterinary Medicine and Animal Welfare in the second reading and as a whole. EBA Animal Health Committee welcomes the adoption of this long-awaited document for business. The new law will help update Ukrainian livestock legislation and bring it into line with European Union standards. The government has simplified the import of enteral nutrition products to Ukraine The European Business Association welcomes the adoption of the CMU Resolution № 54, which clarifies the rules for the import of goods and preparations of enteral nutrition with the inclusion of the position 3004 2106 2202 enteral nutrition products (enteral nutrition). It will be recalled that due to the lack of definition of the term enteral nutrition in the Ukrainian legislation, the customs authorities refuse to allow such goods to cross the state border without additional written confirmation from the competent authority. In practice, the business could not comply with current legislation and after the resumption of inspections, was responsible for violating the requirements of tax law. Language requirements will be changed for the documents submitted for medicines quality certification Starting from January 29, 2021, within 2 weeks, it is possible to submit documents for medicines quality certification in Russian translation with a letter that guarantees the subsequent obligation to translate those documents in the Ukrainian language. The European Business Association is pleased to announce that this was achieved as a result of negotiations between the EBA Health Care Committee and representatives of the State Service of Ukraine for Medicines and Drug Control. The change in the requirements for submitting quality certificates exclusively in Ukrainian was introduced by the State Service for Medicines without prior information and time for preparation of registration certificate holders, which could lead to the termination of supplies of quality and safe medicines to Ukraine. The Procedures for negotiating and concluding managed entry agreements have been approved The European Business Association announces the adoption by the Cabinet of Ministers of Ukraine of the resolution on “Some issues regarding managed entry agreements”. The adopted resolution enables the use of managed entry agreements (MEA) in Ukraine as one of the main modern tools for ensuring patients ’access to original innovative medicines. The implementation of the MEA mechanism in Ukraine will provide access to innovative drugs for the treatment of various serious diseases (including rare diseases, cancer) through the use of direct negotiation procedures that provide for confidentiality of certain conditions with manufacturers of innovative drugs. One of the main prerequisites for the conclusion of the MEA will be the assessment of medical technologies, the procedure for which was approved earlier. The new permissible norms of electromagnetic radiation have been adopted in Ukraine The European Business Association welcomes the adoption of the Order № 2760 of the Ministry of Health on Approval of Amendments to the State Sanitary Norms and Rules for Protection of the Population from Electromagnetic Radiation” of 30 November 2020. The limit values of the electromagnetic field were established at 10 μW / cm2 or 6 V / m for mobile base stations operating in the very high, ultra-high, ultra-high, and extremely high frequencies. Thus, Ukrainian legislation will be harmonized with the practices of EU countries in the context of electromagnetic radiation, where communication stations operate at higher frequencies. This will reduce the potential risks posed by the radiation of cellular terminals to subscribers, as well as accelerate the deployment of 3G and 4G networks in Ukraine, particularly in rural areas. The reform of the state pesticides and agrochemicals testing system has begun On February 5, a significant and strategically important event for the agrochemical sector took place - the Ministry of Justice of Ukraine registered the Order of the Ministry of Environment On approval of the Procedure for authorizing research institutions, enterprises, and organizations to conduct the state testing of pesticides and agrochemicals № 392 of December 28, 2020. The establishment of clear rules of the game will allow in the short term to involve Ukrainian and international networks of private laboratories and research institutions in the state testing, which will positively affect the quality of tests and create market pricing conditions. The Ukrainian and international business community welcomes the approval of the new authorization procedure as an extremely important and positive reform in the field of pesticides and agrochemicals. The annual e-limit on foreign investments and placement of funds on foreign accounts has been increased for individuals The EBA welcomes the decision of the National Bank of Ukraine aimed at currency liberalization, to increase the e-limit for a number of foreign exchange transactions of individuals to transfer funds abroad or to accounts of non-resident legal entities opened in Ukraine. The limit was increased twice - up to 200 thousand euros. We truly thank the Verkhovna Rada of Ukraine, the Government, the Ministry of Health of Ukraine, the Ministry of Justice of Ukraine, and the State Service of Ukraine for Medicines and Drug Control for the important changes that will help improve the conditions for doing business in Ukraine!    

We are extremely pleased to announce that this week has been fruitful for good news and long-awaited positive decisions. We can boast of two solutions in favor of the healthcare industry, as well as achievements in the food, regulatory, veterinary, agrochemical, and electronic payments industries, in brief:

Veterinary legislation has been significantly updated for the first time in Ukraine

On February 4, the Verkhovna Rada adopted, the draft Law №3318 “On Veterinary Medicine and Animal Welfare” in the second reading and as a whole.

EBA Animal Health Committee welcomes the adoption of this long-awaited document for business. The new law will help update Ukrainian livestock legislation and bring it into line with European Union standards.

The government has simplified the import of enteral nutrition products to Ukraine

The European Business Association welcomes the adoption of the CMU Resolution № 54, which clarifies the rules for the import of goods and preparations of enteral nutrition with the inclusion of the position “3004 2106 2202 enteral nutrition products (enteral nutrition)”.

It will be recalled that due to the lack of definition of the term “enteral nutrition” in the Ukrainian legislation, the customs authorities refuse to allow such goods to cross the state border without additional written confirmation from the competent authority. In practice, the business could not comply with current legislation and after the resumption of inspections, was responsible for violating the requirements of tax law.

Language requirements will be changed for the documents submitted for medicines quality certification

Starting from January 29, 2021, within 2 weeks, it is possible to submit documents for medicines quality certification in Russian translation with a letter that guarantees the subsequent obligation to translate those documents in the Ukrainian language.

The European Business Association is pleased to announce that this was achieved as a result of negotiations between the EBA Health Care Committee and representatives of the State Service of Ukraine for Medicines and Drug Control. The change in the requirements for submitting quality certificates exclusively in Ukrainian was introduced by the State Service for Medicines without prior information and time for preparation of registration certificate holders, which could lead to the termination of supplies of quality and safe medicines to Ukraine.

The Procedures for negotiating and concluding managed entry agreements have been approved

The European Business Association announces the adoption by the Cabinet of Ministers of Ukraine of the resolution on “Some issues regarding managed entry agreements”. The adopted resolution enables the use of managed entry agreements (MEA) in Ukraine as one of the main modern tools for ensuring patients ’access to original innovative medicines.

The implementation of the MEA mechanism in Ukraine will provide access to innovative drugs for the treatment of various serious diseases (including rare diseases, cancer) through the use of direct negotiation procedures that provide for confidentiality of certain conditions with manufacturers of innovative drugs. One of the main prerequisites for the conclusion of the MEA will be the assessment of medical technologies, the procedure for which was approved earlier.

The new permissible norms of electromagnetic radiation have been adopted in Ukraine

The European Business Association welcomes the adoption of the Order № 2760 of the Ministry of Health on Approval of Amendments to the State Sanitary Norms and Rules for Protection of the Population from Electromagnetic Radiation” of 30 November 2020. The limit values of the electromagnetic field were established at 10 μW / cm2 or 6 V / m for mobile base stations operating in the very high, ultra-high, ultra-high, and extremely high frequencies.

Thus, Ukrainian legislation will be harmonized with the practices of EU countries in the context of electromagnetic radiation, where communication stations operate at higher frequencies. This will reduce the potential risks posed by the radiation of cellular terminals to subscribers, as well as accelerate the deployment of 3G and 4G networks in Ukraine, particularly in rural areas.

The reform of the state pesticides and agrochemicals testing system has begun

On February 5, a significant and strategically important event for the agrochemical sector took place – the Ministry of Justice of Ukraine registered the Order of the Ministry of Environment “On approval of the Procedure for authorizing research institutions, enterprises, and organizations to conduct the state testing of pesticides and agrochemicals” № 392 of December 28, 2020.

The establishment of clear rules of the game will allow in the short term to involve Ukrainian and international networks of private laboratories and research institutions in the state testing, which will positively affect the quality of tests and create market pricing conditions. The Ukrainian and international business community welcomes the approval of the new authorization procedure as an extremely important and positive reform in the field of pesticides and agrochemicals.

The annual e-limit on foreign investments and placement of funds on foreign accounts has been increased for individuals

The EBA welcomes the decision of the National Bank of Ukraine aimed at currency liberalization, to increase the e-limit for a number of foreign exchange transactions of individuals to transfer funds abroad or to accounts of non-resident legal entities opened in Ukraine. The limit was increased twice – up to 200 thousand euros.

We truly thank the Verkhovna Rada of Ukraine, the Government, the Ministry of Health of Ukraine, the Ministry of Justice of Ukraine, and the State Service of Ukraine for Medicines and Drug Control for the important changes that will help improve the conditions for doing business in Ukraine!

 

 

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