Article 29 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”,\u00a0in particular, stipulates that:<\/p>\n
The\u00a0conditions of the sign of\u00a0conformity were also met\u00a0technical\u00a0regulations\u00a0approved\u00a0by Resolution of the Cabinet of Ministers of Ukraine dated December 30, 2015, \u2116 1184 “On approval of the form, description of the\u00a0mark of conformity with technical regulations, rules, and conditions for its application”.<\/a><\/p>\n In accordance with Article 35\u00a0of the above-mentioned\u00a0Law, the central executive authority, which appoints conformity assessment bodies (Ministry of Economic Development and Trade), assigns identification numbers to the designated conformity assessment bodies.<\/p>\n In this case, only one identification number is assigned to each assigned conformity assessment body, regardless of whether it has been designated in accordance with several technical regulations.<\/p>\n In the orders of the Ministry of Economic Development and Trade on the designation of conformity assessment bodies for the assessment of conformity with the requirements of the relevant technical regulation, the identification number assigned to the designated conformity assessment body in UA.TR.YYY format shall be indicated.<\/p>\n In addition, the decision on the appointment of a conformity assessment authority to perform an assessment of compliance with the requirements of the relevant technical regulation shall also indicate the identification number assigned to the designated conformity assessment body in UA.TR.YYY format.<\/p>\n The above-mentioned normative-legal act\u00a0amended paragraph 3 of the rules and conditions of the\u00a0sign of\u00a0conformity with the technical regulations approved by the decree of the Cabinet of Ministers of Ukraine dated December 30, 2015, No. 1184 ”\u00a0On approval of the form, description of the\u00a0mark of\u00a0conformity to technical regulations, rules and conditions for its application<\/a>\u00a0” .<\/p>\n Thus,\u00a0during the marking of products by the mark of conformity to technical regulations, operators of the market\u00a0from 04.01.2018 are\u00a0allowed to affix the identification number of the designated conformity assessment body if such an authority was involved at the stage of production control, as in the full UA.TR.\u00a0120, and in the abbreviated format\u00a0120.<\/p>\n By this date, it was allowed to apply the<\/strong>\u00a0identification number of the designated conformity assessment body<\/strong>\u00a0to medical products only in full format<\/strong>\u00a0, as evidenced by the\u00a0explanation of the\u00a0Ministry of\u00a0Economic Development and Trade of Ukraine\u00a0regarding the format of the identification\u00a0number of the designated\u00a0assessment\u00a0authority\u00a0from January 26,\u00a02017 No. 3633-06 \/ 2446-03\u00a0.<\/p>\n At the same time, the Ministry of Health of Ukraine as a body of technical regulation in the field of medical products, taking into account the explanations of the Ministry of Economic Development,\u00a0issues a clarification letter\u00a0dated 08.10.2017\u00a0 to the market surveillance authority for medical products of the State Medical Service of Ukraine, in which it is noted\u00a0that the use of a serial number in the format “YYY” under the national\u00a0conformity marker allows identification of the\u00a0conformity assessment body that\u00a0issued the certificate of conformity for this product.<\/p>\n Such a conclusion of the Ministry of Health of Ukraine issued on\u00a0numerous appeals of the operators of the\u00a0market of medical products and\u00a0in connection with the strategic importance for the security of the state availability of the sufficient\u00a0number of medical products in the customs territory of Ukraine.<\/p>\n At the same time, the Ministry of Health of Ukraine stresses\u00a0that the national\u00a0mark of conformity of Ukraine\u00a0is unique and not repeated in any country in the world.\u00a0On the\u00a0application of the serial number of the conformity assessment body in the\u00a0abbreviated\u00a0format ”\u00a0YYY\u00a0” under the national\u00a0conformity\u00a0mark\u00a0can affect the\u00a0quality.<\/p>\n However, letters from\u00a0ministries and other\u00a0central executive bodies are\u00a0not normative and legal acts, they are only explanatory,\u00a0informational\u00a0and\u00a0do not\u00a0establish legal norms.<\/p>\n Designated conformity assessment body\u00a0IMPROVE<\/strong>\u00a0MEDICAL<\/strong>\u00a0has an identification number\u00a0(ID)<\/strong>\u00a0UA.<\/strong>TR.120.<\/p>\n IMPROVE<\/strong>\u00a0MEDICAL<\/strong>\u00a0from the beginning of its activities (appointment) is doing exclusively by the current legislation regulating the field of medical products, and has always emphasized to its clients the correctness of marking the national conformity mark in the full format, namely,\u00a0UA.\u00a0TR\u00a0.120, since\u00a0the format was only allowed in Ukraine from January 4, 2018, in view of the adoption of the resolution<\/strong>\u00a0The Cabinet of Ministers of Ukraine<\/strong> No. 1027 dated December 20, 2017, “On Amendments to Clause 3 of the Rules and Terms of Affixing the\u00a0Sign of\u00a0Compliance with the Technical Regulations”.<\/a><\/p>\n Violations connected with the indication of the\u00a0ID\u00a0of the conformity assessment body, in 2017, often became subject to the application of penalties by the market surveillance authority, the State Service of Internal Affairs, during its implementation of its and its territorial bodies of measures.<\/p>\n