Impact of COVID-19 on regulatory processes in Eastern Europe and Central Asia

Today the issue of the spread and prevention of coronavirus infection (COVID-19) is one of the most discussed and acute. World organizations and governments take active actions daily, relying on the relevant support from business.

In many countries where we operate, the mechanisms for simplified market access for medical products are introduced, duties and taxes are temporarily abolished. Meanwhile many competent authorities and expert organizations have switched to the limited mode of operation and in some cases have stopped accepting paper documentation.

We present a brief analysis on the current situation in 12 countries, on taken actions and impact on regulatory legislation and ongoing processes on medicines, medical devices, disinfectants and personal protective equipment.

Armenia

Since 16 March, a state of emergency due to the spread of COVID-19 has been declared, provisionally until 14 April. All public and educational institutions and shopping malls are closed. Public transport is disinfected daily. Mass events are prohibited, while meetings of up to 20 people are allowed. The Ministry of Health recommends transferring all employees to remote work.

Entry into the country is prohibited, exceptions are only Armenian citizens and people with residence permits. All visitors are subject to mandatory 14-day quarantine.

Import of specific medical devices, personal protective equipment and disinfectants into the territory of Armenia has been simplified. According to the Decision of the Eurasian Economic Commission import of personal protective equipment and medical devices necessary to combat infection is free from import duty within all EAEU member-states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia). Export of a wide range of personal protective equipment outside the EEA is prohibited.

The Cabinet of Ministers informs about the fixation of prices for medical masks (200 drams) at the state level, as well as about limited leave from pharmacies of medical products of prime necessity. Some local production facilities have been re-equipped to supply the population with medical masks.

Competent authorities for medicines and medical devices are working in limited mode. All necessary documentation should be submitted in electronic format, by e-mail. On 18 March 2020, the website of the Scientific Center of Expertise published the Instruction on cooperation between the Regulatory Authority and the Applicants during the emergency period. A visit to the reception desk or direct contact with the experts is expected only in exceptional cases. Many experts are organized to work remotely.

As for today the overall impact on the regulatory procedures is minor, however some delays can occur.

All necessary information on measures undertaken and recommendations are regularly published on the official website of the Government of the Republic of Armenia https://www.gov.am/ru/news/.

Azerbaijan

The country has introduced a quarantine: all public institutions, shopping malls, cinemas and restaurants are closed until April 24. Working hours of public transport are limited until 21:00. Educational institutions are closed from March 19 to April 18. Mass events have been cancelled, as well as the celebration of the national holiday Novruz (Novruz Bayrami), which was scheduled from March 19 to 29 as a public weekend. The state of emergency has not been declared, patients with coronavirus are treated in special sections of the Central Clinical Hospital.

The borders with neighboring states (Iran, Turkey, Georgia, Russia) are closed. Intercity traffic is open, but only registered cars are allowed to enter the capital.

An Operational Headquarters has been established under the Cabinet of Ministers that regulates all issues related to the COVID-19 pandemic.

Import regime for medical devices of prime necessity is simplified. Such products as bahillas, sterile and non-sterile gloves, medical masks (for surgical operations and procedures), respirators are exempt from import duties until June 1, 2020. The government has purchased additional personal protective equipment and medical devices (ventilators), increased production of medical alcohol.

There is no requirement for medical device state registration in Azerbaijan. State registration of medicines has not been changed, simplified/upgraded procedures have not yet been introduced.

To date, changes to the operating schedule of the competent authority Center for Analytical Expertise have not been announced. The decision can be made after March 30, after the end of the state holidays. Document exchange is not affected yet. According to regulatory requirements, all registration materials should be submitted to the competent authorities in paper form.

As for today the impact of COVID-19 on registration processes in Azerbaijan is minor, impact on the medical market is insignificant.

All necessary information on measures taken is published daily on the website of the Cabinet of Ministers of Azerbaijan https://cabmin.gov.az/az/archive/news/.

Belarus

No special measures have been introduced in the country, no official quarantine: schools and universities, shopping malls, restaurants and public places are working in regular mode. Some changes have been introduced in public transport operating hours to separate passenger flows.

According to the Decision of the Eurasian Economic Commission import of personal protective equipment and medical devices necessary to combat infection is free from import duty within all EAEU member-states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia). Export of a wide range of personal protective equipment outside the EEA is prohibited.

The work of the competent authorities remains mainly unchanged. Submissions and documentary exchange are unaffected. Since March 18 consulting on issues related to the assessment procedures for medicines and medical devices should be carried out only by telephone and in accordance with the schedule of online registration.

At present, there is no impact of COVID-19 on regulatory processes.

Georgia

From March 21, the state of emergency is declared until April 21. All public institutions, educational institutions, shopping centers are closed, and events involving more than 10 people are prohibited. Since March 18, a ban on all foreign citizens has been introduced.

There is no information on special measures regarding the tariff regulation of medicines, medical devices and personal protective equipment. Simplified registration procedures have not been introduced.

The Agency for the Regulation of Medical and Pharmaceutical Activities LEPL is working in remote mode. In order to comply with the terms and rules of procedure established by law, organizations involved in the registration of pharmaceutical products must submit documents to the Office of the Ministry of Labor, Health and Social Protection of Georgia on Mondays and Thursdays.

To date, there has been little impact on regulatory processes, but slight delays may occur.

Also a website https://stopcov.ge/en has been created to prevent the spread of COVID-19 and inform citizens.

Kazakhstan

From March 16, a state of emergency was declared in the country, and traffic was limited in Nur-Sultan and Almaty from March 19 to April 22, 2020. All public places, shopping and entertainment centres, cinemas are closed. Since 28 March in Nur-Sultan and Almaty citizens have been restricted from leaving their places of residence, except for the purchase of food, medicine and access to work, operation of public transport has been restricted.

In accordance with the Decree of the President of the Republic of Kazakhstan “On introduction of the state of emergency in the Republic of Kazakhstan” dated March 15, 2020, as well as in connection with quarantine in Nur-Sultan and Almaty, from March 19, 2020 the National Center for Expertise of Medicines and Medical Devices has switched to remote mode/digital format of communication. During the state of emergency, the telephone lines of the Center for Expertise will not be serviced, and all receptions of citizens and Applicants will be cancelled. Contact with the Center for Expertise should be made only by email.

From March 10 to May 1, 2020 the evaluation (inspection) of production conditions and quality assurance systems for manufacturers of medicines and medical devices in other states will be postponed. This decision will remain valid until the emergency situation ceases.

To date, the impact on regulatory processes is minor, but slight delays may occur.

All necessary information on measures taken and recommendations are regularly published on the official website of the Ministry of Health of the Republic of Kazakhstan http://www.gov.kz/memleket/entities/dsm/press/news.

Kyrgyzstan

On March 22, an emergency situation was introduced, kindergartens, schools and universities are under quarantine regime, restaurants and other public places are closed. From March 25 a state of emergency is introduced till April 15, 2020. A curfew has been introduced in Bishkek, public transport has been completely stopped, and only grocery stores and pharmacies, banks and life support facilities are operating.

Decree No. 178 of 23 March 2020 authorizes the supply without state registration of medicines and medical devices (subject to registration in the country of manufacture) included in the National List of Essential Medicines and Medical Devices of the Kyrgyz Republic and/or the list of medicines and medical devices necessary for diagnosis and treatment of coronavirus infection. For such medicines and medical devices it is necessary to affix a sticker and provide instructions for use in the state and/or official languages.

The decision of the Eurasian Economic Commission on duty-free import of personal protective equipment and medical devices necessary to combat infection into the territory of the EAEC Member States (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) was adopted. A decision was taken to prohibit the export of a wide range of personal protective equipment outside the EAEC.

The Department of Medicinal Products operates as usual.

To date, the impact on regulatory processes is absent.

The website of the Ministry of Health of the Republic contains information on coronavirus and on measures taken by the State to combat the spread of infection: http://www.med.kg/ru/koronavirus.html.

Moldova

Since March 14, code red has been declared in the country – the highest level of security measures to combat infection. Since March 17 Moldova has been in a state of emergency until May 15. The country has stopped classes in all educational institutions, closed the borders, cancelled air traffic and closed the Chisinau airport. All international trains and bus routes are closed. Shopping centers and all other public places are closed, except for grocery stores, pharmacies and gas stations. Public transport operates only on weekdays.

The Medicines Agency, the competent authority in Moldova, continues to operate as usual. Switch to electronic document exchange has not yet been introduced, but contacts with applicants are limited and many experts have moved to remote work.

So far, the impact on regulatory processes is insignificant, but we assume delays in the processes of expertise, invoicing and signing contracts, approval and issuance of registration documents.

All necessary information on the measures taken is published daily on the website of the Ministry of Health https://msmps.gov.md/.

Mongolia

The country announced an extensive quarantine on 10 March, which is in effect until specific notice. Educational institutions and all public places except grocery stores have been closed. All regular flights and rail communication have also been stopped. Border crossing points have been closed and foreigners are prohibited from entering the country.

In order to curb the spread of COVID-19, the Government of Mongolia decided to tighten and continue implementing preventive measures until 30 April 2020.

As of today, the impact on regulatory processes is not significant, slight delays are possible.

Tajikistan

Tajikistan remains one of the few countries in the world that claim to have no COVID-19. Despite this, the country is taking preventive measures to protect against its spread, although no official quarantine has yet been introduced.

To counter the penetration of coronavirus into the territory of Tajikistan international air traffic from March 20 and all other passenger traffic from March 23 has been stopped from tentatively until May 1, 2020. All citizens who have returned from countries with an active spread of coronavirus, must be placed in a quarantine and undergo medical examination.

The State Health and Social Protection Supervision Service of the Ministry of Health is operating in regular manner.

To date, there has been no impact on regulatory processes.

All necessary information on measures taken and recommendations are published on the website of the Ministry of Health at https://moh.tj/?lang=ru.

Turkmenistan

To counter the spread of the coronavirus, the Government of Turkmenistan imposed a blockade regime in Ashgabat and restricted the movement of citizens between the country’s regions. However, according to official data, no cases of coronavirus have been detected in Turkmenistan.

To date, no quarantine or other restrictive measures have been introduced. There have been no simplifying changes in the rules for the import and sale of medical devices, medicines, personal protective equipment or disinfectants.

The Medicines Registration Centre operates in a normal mode: it receives and issues registration documents and signs registration certificates. The documentation should be submitted in paper form.

To date, there has been no impact on registration processes in Turkmenistan.

Uzbekistan

A quarantine regime has been introduced in the country since March 16. The work of shopping centers, restaurants and public transport has been stopped. Almost all institutions, where technically possible, are switched to remote operation. In the capital since March 22, public transport, including the subway, has been stopped. It is permitted to move only by personal transport or by taxi. In addition, since March 23, fines have been imposed for being in public places without a protective mask.

State control over prices for medical devices of prime necessity has been introduced.

Since 22 March, under article 243 of the Tax Code, the circulation of face masks is exempt from VAT.

The competent authorities responsible for registering medical products work in a standard mode and accept documents in paper form. There are no simplified registration procedures related to coronavirus. Pharmaceutical site inspections are suspended for the period of quarantine, and will be resumed as soon as quarantine will be over (the registration process is suspended for such a period).

At present, the impact on regulatory processes is insignificant.

The Ministry of Health of Uzbekistan has launched the official website http://coronavirus.uz/ru, where all necessary information on coronavirus infection (COVID-19) in Uzbekistan can be obtained.

Ukraine

From March 12, Ukraine introduced a quarantine regime, which intended to last until April 3, but by the government’s decision of March 25 on the introduction of an emergency situation throughout the country was extended until April 24.

Since March 17, all checkpoints for international passenger traffic have been closed in Ukraine, the metro has been stopped in the capital, and since March 23 public transport is allowed only for passengers with special passes. Similar actions have been introduced in other cities.

A set of legal acts for preventing and treating of coronavirus infection has been implemented:

a simplified public procurement mechanism,
the possibility of purchase of unregistered medicines,
exemption from import VAT and duties,
special permits in the interests of public health for the introduction of unregistered medical products.

The above norms are temporarily applicable only to the list of medicines, medical devices, personal protective equipment and disinfectants defined by the Cabinet of Ministers.

On March 25, amendments were approved to unblock and simplify the procedure for state registration of disinfectants.

Quarantine activities affect the work of the competent authorities and institutions, which have been temporarily switched to remote working and electronic document exchange. No inspections or on-site audits are conducted during quarantine. Some experts have switched to remote work.

For today influence on regulatory processes is insignificant, minor delays are possible.

Confirmed information is published on the official communication channels of the Ministry of Health of Ukraine: http://www.moz.gov.ua/, and for answers to the main questions about COVID-19 the website: http://covid19.com.ua.

Most of our employees have been transferred to remote work and continue absolutely all current tasks in the standard working schedule. Negotiations with partners are conducted by phone or other means of telecommunication, mail and parcels are received uninterruptedly.

In general, all ongoing processes are performed on time, at the expected quality and expertise level. Our entire team is available by email, for quick communication we recommend using the mobile phones indicated in the signature of each expert.

Take care!

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