The Information Service Centre IMPROVE MEDICAL has prepared the latest news digest on “medical products” especially for you, where we share with you the following news:
- On status of modifications to the Medical Product Technical Regulations and approval of Cosmetic Product Regulation
Earlier, in the previous digest we gave information about public discussion on a new version of:
– the draft resolution of the Cabinet of Ministers of Ukraine “On approval of the Cosmetic Product Technical Regulation” which was posted on the official site of the Ministry of Health of Ukraine on July 17, 2019, at;
– the draft resolution of the Cabinet of Ministers of Ukraine “On introduction of changes in some Resolutions of the Cabinet of Ministers of Ukraine” (in terms of changes in the Medical Product Technical Regulations No. 753-755) which was posted on the official site of the Ministry of Health of Ukraine on July 01, 2019, at;
According to information received from the Association “Operators of Medical Product Market”, whose member the IM is since 2016, these drafts failed to receive coordinated approval at the pertinent central executive bodies and were sent back to the drafter, the Ministry of Health of Ukraine, for further improvement.
Taking into account that the new Government is formed in Ukraine and the new Prime Minister is appointed, and in view of the effective version of the Cabinet of Ministers of Ukraine Regulation, it may be noted that these drafts shall be put before public again, and earlier comments shall be kept in mind.
It is worth reminding that the most severe changes in Technical Regulations No. 753-755 were proposed by the Ministry of Health of Ukraine; they are related to the new notion of an authorized representative through the reference rules of the Law of Ukraine “On Technical Regulations and Conformity Evaluation”, so that restriction of the right is possible for representative offices of foreign legal entities (non-residents of Ukraine) to perform functions of an authorized person of medical product manufacturers in Ukraine.
- The National Classifier of medical products is imbedded in the Prozorro System
The Association “Operators of Medical Product Market” specifies that one of the expected consequences of the National Classifier of medical products creation and starting is the fact that a new field – classifier of medical products НК 024: 2019 has appeared in the Prozorro System. Now customers shall select the name of the medical product from the list..
The legal basis to the effect is the Order of the Ministry of Economic Development of 17.03.2016, No. 454 “On Approval of the Procedure of Procurement Item Determination (with modifications that became valid since 14.06.2019), whereby the procurement item shall be specified in the course of purchase procedure by the index of the fourth figure of the Unique Purchase Vocabulary and indication of the code and name of the medical product, in brackets, in accordance with Classifier НК 024: 2019 “Classifier of Medical Products” approved by the Order of the Ministry of Economic Development and Commerce of Ukraine of February 05, 2019, No. 159.
Should the procurement item of medical products includes two or more articles, the customer shall indicate the code and name of each medical product, in brackets.
The Classifier is available through the link, its maintenance is realized by the State Ukrainian Association “Politechmed”.
- the draft law of Ukraine “On Annulment of the Law of Ukraine of April 25, 2019, No. №2704-VIII” On Management of Ukrainian Language as State Language”, was registered with the Verkhovna Rada of the IX-th convocation on August 29, 2019, file number 1102.
It is worth reminding that the Law of Ukraine of April 25, 2019, No. №2704-VIII” On Management of Ukrainian Language as State Language” came into effect (save and except some provisions) on July 16, 2019.
The card of the draft law and explanatory note is located through the link.
- IMPROVE MEDICAL UA.TR.120 organized two training webinars in August 2019
– webinar on “Special aspects of compliance evaluation for OBL-OEM production” on August 22; the following issues were considered:
- OBL and ОЕМ production under the contract on medical products::
– algorithm of foundation of a legal manufacturer on the basis of an office without production operations.
– requirements to the OEM-contract:
- special aspects of compliance evaluation for OBL-OEM production;
- special aspects of manufacturer’s OBL system construction;
- general technical documentation requirements;
- passing of compliance audits, extension of certificate scope.
– webinar on “Post-marketing surveillance. New requirements for introduction of medical products in Ukraine” on August 29; the following issues were considered:
- what is post-marketing clinical evaluation and its importance for quality and safety of a medical product?
- program and methodologies of post-marketing clinical evaluation procedure;
- principal accents on issues of post-marketing clinical evaluation plan and report;
- decisions made by the manufacturer on the basis of results of the post-marketing clinical evaluation;
- examination of results of post-marketing clinical evaluation by a compliance evaluation agency.
Should you be interested in the aforesaid topics, you may see video-records of these events and receive access to webinar materials by sending the appropriate inquiry to our е-mail firstname.lastname@example.org.
Moreover, if any question arises with respect to special aspects of application of the legislation of Ukraine in the sphere of technological regulation of the medical product market, post-marketing surveillance and clinical evaluation, certain issues of OBL and OEM production of medical products, etc., please, do not hesitate to contact the IMPROVE MEDICAL UA.TR.120 team by telephone 044 355 50 30 or е-mail email@example.com.
- The draft law of Ukraine “On Introduction of Modifications in the Law of Ukraine ‘On Public Purchases” and some other legislative acts with respect to improvement of public purchases” were also registered with the Verkhovna Rada of the IX-th convocation on August 29, 2019
The draft law was elaborated together with the Ministry of Economic Development and Commerce of Ukraine and the Office of the President.
On August 29 the President of Ukraine qualified draft law No. 1076 as urgent, and people’s deputies supported the abbreviated procedure of consideration of this draft law.
Principal provisions of the project:
– a concept of “simplified” purchases is introduced – it relates to purchases of goods, works and services to the amount of 50 to 200 thousand UAH; these purchases shall be made through Prozorro system;
– possibility for the business entity to correct mistakes in the tender bid within 24 hours;
– e-catalogues operation (Prozorro Market – see more information at).
The draft law will allow a customer to use the electronic catalogue as an alternative to simplified purchase procedure:
– change-over to Authorized persons instead of Tender Committees;
– a mechanism of fight against bad-faith suppliers is fixed.
If the supplier fails to fulfill provisions of the contract, the customer shall have the possibility to refuse to cooperate with such supplier for the next three years. However, if the business entity shall provide valid evidence of its sustainability and compensate actual damage, it will receive the second chance to participate in purchases of this customer:
– upgrading of penalties for executive officers for any infringement of legislation in the sphere of public purchases through introduction of modifications in the Code of Administrative Infractions.
Hence, imposition of administrative sanctions shall be made on the grounds of: baseless application of the negotiated purchase procedure, baseless disqualification, baseless assignment of the winner from among the participants, introduction of modifications in material terms and conditions of purchase contract in cases which are not specified by the legislation.
The forfeit for non-fulfillment of the decision of appeal authority shall amount to 85 thousand UAH for goods acquisition, and 34 thousand to 170 thousand UAH for acquisition of goods, works and services to / without carrying out procedures;
– business will receive more possibilities to assert its rights because the draft law suggests the noticeable improvement of the mechanism of bidding process appeal in the Anti-monopoly Committee of Ukraine;
– within the framework of harmonization with the EU legislation and international standards it is proposed to extend the list of competitive procedures, give enterprise associations the right to participate in procurement activities, fix the right of customers to hold pre-tender communications with business.
A new instrument of fight against damping will appear as well – the system will highlight an anomalously low price. The supplier shall have to justify it in order to sign a contract with the customer.
The card of the draft law and explanatory note is located through the link.
- The Information Service Centre IMPROVE MEDICAL UA.TR.120 announces holding of autumn training seminars, which are free-to-attend:
Thursday, October 03, 11.00 – Medical product labeling. Issues of language policy. Graphics characters. Instruction (transfer from September 19, 2019). Pre-registration is compulsive at.
Thursday, October 24, 11.00 – Recognition of the results of medical products compliance evaluation in the EU. Pre-registration is compulsive at.
Webinars speaker – Svetlana Zgonnik, Director, auditor/expert, IMPROVE MEDICAL.
Language – Ukrainian/Russian
Conditions of participation: free-to-attend events
On issues relating to participation in our webinars please contact us by telephone 044 355 50 30 or е-mail firstname.lastname@example.org
We shall appreciate receiving information about topics which are interesting for you at our upcoming free-to-attend events, as well as your comments, clarifications.
Svetlana Zgonnik and improvemed.com.ua team