Deal colleague, you are welcome!
Greetings the designated conformity assessment body IMPROVE MEDICAL UA.TR.120.
The Information Services Center of IMPROVE MEDICAL specifically for you has summarized the main regulatory news in the market of medical devices since release of the previous digest 2020.
Please see below the second news digest in 202XA0 in the field of “medical products”.
- According to Resolution of the Cabinet of Ministers of Ukraine of March 11, 2020, quarantine was introduced in the territory of Ukraine for the period from March 12 to April 3, 2020.
In addition, on March 17, 2020, the Verkhovna Rada of Ukraine adopted a number of laws related to the prevention of emergence and spread of coronavirus disease (COVID-19), which have now become effective.
The laws envisage many changes in various fields of activity of both legal entities and individuals, will directly affect the conduct of business in quarantine conditions, and it is extremely important to adapt to such changes quickly and correctly.
Information on security measures during the period of quarantine is available on the corresponding web-site of the Cabinet of Ministers of Ukraine.
- ATTENTION! The conformity assessment body IMPROVE MEDICAL due to force majeure circumstances in connection with the spread of coronavirus in the territory of Ukraine (COVID-19) has changed the working schedule of its office.
Our specialists were transferred partially to remote work, and some employees are in the office with a flexible work schedule.
Communication with our employees is established and maintained as usual, without any disruption.
The conformity assessment body IMPROVE MEDICAL guarantees that all projects will be completed on time, as agreed upon.
Earlier this month, the conformity assessment body IMPROVE MEDICAL fully passed the annual supervisory audit from the National Accreditation Agency of Ukraine (NAAU) and confirmed its right (accreditation certificate) to perform work on conformity assessment of medical devices.
- Let us consider the Law of Ukraine “On Amending Some Legislative Acts of Ukraine aimed at Preventing the Emergence and Spread of Coronavirus Disease (COVID-19)” of March 17, 2020, No. 530-IX
On March 17, 2020, the Verkhovna Rada of Ukraine adopted the Law of Ukraine “On Amending Some Legislative Acts of Ukraine aimed at preventing the emergence and spread of coronavirus disease (COVID-19)”.
The Law of Ukraine became effective on March 17, 2020.
The basic provisions are as follows:
- Temporarily, for the implementation of measures to prevent the emergence and spread of coronavirus disease (COVID-19), the transactions on import of medicines, medical devices and/or medical equipment necessary for the implementation of measures aimed at preventing the emergence and spread, localization and elimination of outbreaks, epidemics and pandemics of coronavirus disease (COVID-19), the list of which is determined by the Cabinet of Ministers of Ukraine, are exempted from VAT.
- Temporarily, for the implementation of measures to prevent the emergence and spread of coronavirus disease (COVID-19):
– medicines, medical devices and/or medical equipment necessary for the implementation of measures aimed at preventing the emergence and spread, localization and elimination of outbreaks, epidemics and pandemics of coronavirus disease (COVID-19), the list of which is determined by the Cabinet of Ministers of Ukraine, are exempted from import duties;
– customs clearance of such goods is carried out on a first-priority basis;
– it is permitted to submit a preliminary or temporary declaration for such goods in accordance with the rules established by the Customs Code;
– payment for the customs formalities outside the location of the customs authorities or outside of the working hours established for them is not charged with respect to such goods.
It shall be noted that the new regulatory acts do not limit the import and export of goods, as well as their internal movement throughout the country.
The only exception is the export of anti-epidemic products included in a specific list (e.g. medical masks, medical gloves, etc.), the export of which is prohibited by June 1, 2020.
The detailed list of such products can be found at link.
- The Law of Ukraine “On Public Procurement” will not apply to cases where the subject of procurement is the goods, work or services necessary to carry out activities aimed at preventing the emergence and spread, localization and elimination of outbreaks, epidemics and pandemics of coronavirus disease (COVID-19).
The list of such goods, works or services and the procedure for their procurement are approved by the Cabinet of Ministers of Ukraine.
Procurement of products to combat COVID-19 may be carried out for 100% prepayment.
- The Cabinet of Ministers of Ukraine is instructed to ensure control over the prices of medicines, medical supplies and socially significant goods.
- The ban has been introduced on conduct by the state supervision bodies of planned measures for exercising of state control in the field of economic activity.
It shall be prohibited for the state supervision (control) bodies to carry out planned measures for exercising of state supervision (control) in the field of economic activity until May 31, 2020, with the exception of business entities with a high degree of risk, entities in the field of compliance with the requirements regarding state regulated prices and in the field of sanitary and epidemic well-being of the population.
- The list of medicines, medical devices and/or medical equipment necessary for the implementation of measures aimed at preventing the emergence and spread, localization and elimination of outbreaks, epidemics and pandemics of coronavirus disease (COVID-19), which are exempted from import duties, and transactions for the import of which into the customs territory of Ukraine are exempt from value added tax, has been approved (hereinafter, the List)
On March 20, 2020, by Resolution of the Cabinet of Ministers of Ukraine No. 224 in accordance with paragraph 71, subsection 2, section XX “Transitional Provisions” of the Tax Code of Ukraine and paragraph 96, section XXI “Final and Transitional Provisions” of the Customs Code, the appropriate List was approved.
The list contains:
– medicines for delivery of healthcare to the patients with COVID-19 (80 items);
– disinfectants and antiseptics (15 items);
– medical equipment for healthcare facilities delivering healthcare to the patients with COVID-19 (74 items);
– medical devices, laboratory equipment, consumables, reagents for laboratory research (52 items).
It is specified that the codes given in the List according to the Ukrainian Classification of Goods of Foreign Economic Activity are given for reference.
The basis for exemption from VAT and import duties of the goods imported into the customs territory of Ukraine shall be the conformity of such goods to the name of the product (medical device, main component), the international non-proprietary name (names) of the medicinal product specified in the List.
The list and the document are available at link.
- The draft law “On Amending Some Legislative Acts (Regarding Settlement of Prices for Medicinal Products)” is likely to be rejected
The Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance (hereinafter referred to as the Committee) decided to recommend that the Verkhovna Rada of Ukraine reject the draft law amending some legislative acts (regarding regulation of prices for medicinal products), (reg. No. 2735 of January 14, 2020), filed by people’s deputy D.S. Kostyuk.
When considering at a plenary meeting of the Verkhovna Rada of Ukraine, it is proposed that the co-rapporteur on this issue shall be Mikhailo Borysovych Radutskyi, people’s deputy of Ukraine, the Chairman of the Committee on National Health, Medical Assistance and Medical Insurance.
Recall that on January 14, 2020, under number 2735, people’s deputy D.S. Kostyuk registered the said draft law, the text of which is available at link, and the essence is the resumption of state regulation of prices for medical devices and restrictions on competition.
Currently, the document is awaiting consideration in the Verkhovna Rada (on March 12, 2020, the Committee submitted a rejection notice).
- The AMCU monitors the situation in the pharmaceutical markets and warns against unjustified price increases. Changes in the work of the AMCU boards.
The Antimonopoly Committee of Ukraine officially announced that the facts of unjustified increase in prices for medicinal products and hygiene items will be studies thoroughly in the shortest possible terms. The same refers to other potential abuses, such as creation of artificial deficit.
For anticompetitive behavior in the market, the AMCU may impose a fine of up to 10% of the annual turnover of the perpetrator.
In addition, to prevent the spread of coronavirus COVID-19 and in accordance with the Resolution of the Cabinet of Ministers of Ukraine “On preventing the spread of coronavirus COVID-19 in the territory of Ukraine” of March 11, 2020, No. 211, the Antimonopoly Committee changes the procedure for the parties to participate in the meetings of the Permanent administrative board for reviewing complaints about violation of public procurement law.
In particular, from March 18, 2020, for the period of quarantine, the Antimonopoly Committee of Ukraine introduces the following security measures:
– the right of the parties to participate in the meetings of the Board is exercised by the full statement by the subject of appeal and/or the client of his position in written explanations, which must be downloaded in the Prozorro system.
If it is impossible to provide information in writing, the party submits a motion with justification.
Having considered the motion, the Board may decide on participation of the party in the meeting through a video communication system;
– pursuant to paragraph 6, Art. 18 of the Law of Ukraine “On Public Procurement” to ensure the openness of consideration of complaints, the presence of third parties at the meetings will be provided by video broadcasting the work of the Board on its Facebook page;
– the number of persons who can simultaneously be present in the premises of the AMCU (including in the waiting room and meeting rooms of the Board) will be limited).
- According to Regulation of the Cabinet of Ministers of Ukraine of March 14, 2020, No. 285-p, certain powers of Viktor Kyrylovych Liashko, Deputy Minister of Health – the Chief State Sanitary Doctor of Ukraine, were determined
– on epidemiological surveillance (observation), on the prevention of emergence and spread of human infectious diseases, the localization and elimination of their outbreaks and epidemics, except for measures of state supervision (control) and the issuance of permits;
– designate the authorized persons to exercise the powers of the chief state sanitary doctors of the respective administrative-territorial units, water, rail, air transport for epidemiological surveillance (observation), prevent the emergence and spread of human infectious diseases, localize and eliminate their outbreaks and epidemics, except for measures of state supervision (control) and the issuance of permits.
Recall that earlier, according to Regulation of the Cabinet of Ministers of Ukraine of February 26, 2020, No. 163, the Deputy Minister of Health was authorized to approve and sign certain types of documents, the authority to approve and sign which refer to the competence of the chief state sanitary doctor of Ukraine in terms of powers on epidemiological surveillance (observation).
- In connection with the change of the Government of Ukraine, the Ministry of Health is likely to re-conduct public discussion of the following draft regulatory acts that have already been discussed:
– draft resolution of the Cabinet of Ministers of Ukraine “On amending some Resolutions of the Cabinet of Ministers of Ukraine regarding the improvement of technical regulations for medical devices” of January 23, 2020;
– draft resolution of the Cabinet of Ministers of Ukraine “On approval of the Technical Regulations for Cosmetic Products” of January 23, 2020;
– draft order of the Ministry of Health of Ukraine “On approval of the Procedure for organization of work on state registration (re-registration) of disinfectants and maintenance of the State Register of Disinfectants” of February 6, 2020.
In accordance with paragraph 40 of the Regulations of the Cabinet of Ministers of Ukraine in case of stepping down from office or resignation of the Cabinet of Ministers, the Secretariat of the Cabinet of Ministers returns draft acts to the main developers for re-submission if necessary for consideration by the Cabinet of Ministers after acquiring powers by the newly formed Cabinet of Ministers.
- Register of persons responsible for putting medical devices into circulation: the State Service of Ukraine on Medicines and Drugs Control will accept applications/questions in electronic form
The State Service of Ukraine for Medicines and Drugs Control reported that due to a change in the operating mode, questions arising when entering information into the Register of Persons Responsible for Putting Medical Products Into Circulation, as well as Consumption, Use or Distribution of Medical Products, shall be sent in electronic form.
Such questions shall be sent to the email address: email@example.com, and all the questions sent shall be provided to the division of state market supervision over circulation of medical devices.
You can contact the institution:
– to the official email address (firstname.lastname@example.org);
– through “Section of citizen appeals”, a link to which is available on the official website of the State Service of Ukraine for Medicines and Drugs Control (dls.gov.ua);
– by submitting and tracking online applications for obtaining permits provided by the State Service of Ukraine for Medicines and Drugs Control (through website e-services.dls.gov.ua).
The State Service requests business entities to limit the number of appeals related to the provision of administrative services (issuing licenses, certificates, permits, etc.) and postpone them until May and, unless absolutely necessary, not to send paper copies of documents.
If necessary, applicants have the opportunity to resolve most issues without personal visits, using the electronic communication and the online service of the web portal of the State Service.
- The Information Services Center of IMPROVE MEDICAL UA.TR.120 annoubces MEDICAL DEVICE FORUM 2020 – The new regulation MDR – June 22, 2020
Pre-registration is required by link.
For the first time in Ukraine, Managing Director of the Notified Body of MEDCERT GmbH – Klaus-Dieter Ziel
What do you get by participating in the forum:
– thorough theoretical knowledge and practical skills in the application of the new MDR regulation on medical devices in the EU;
– the impact of MDR on importers and distributors in Ukraine;
– learn about the procedure and peculiarities of conformity assessment by recognizing the reports of the EU Notified Authorities;
– the professional recommendations on the formation of a technical file for medical devices and much more.
- The Information Services Center of IMPROVE MEDICAL UA.TR.120 announces a paid webinar “Risk analysis and management in accordance with the requirements of DSTU EN ISO 13485”
The webinar will be held on April 16, 2020 at 11:00 Kyiv time.
The cost of participation is UAH 1,500.
QUESTIONS FOR CONSIDERATION:
– Risk analysis and management system: how to stop being afraid of it?
– Risk management plan.
– Risk assessment for each dangerous situation.
– Risk management report.
– What does effective risk management depend on?
– How to make risk management a mechanism for continuous improvement?
By participating in our webinars, you can ask your questions and get competent answers, as well as learn how to use the acquired knowledge in practice.
Registration is open here link.
Recall that the Action Plan for 2020 is available on our website by link.
For participation in our training events, please contact 044 355 50 30 or е-mail: email@example.com
Best regards, sincerely yours, Svetlana Zgonnik and the team of improvemed.com.ua.