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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of October 2, 2013 No. 754

About approval of the Technical regulation of rather medical products for diagnosis of in vitro

(as amended on 25-11-2022)

According to article 5 of the Law of Ukraine "About technical regulations and assessment of conformity" the Cabinet of Ministers of Ukraine decides:

1. Approve the Technical regulation of rather medical products for diagnosis in vitro and the actions plan on its use which are applied.

2. To provide to public service on medicines and control of drugs use of the Technical regulation approved by this resolution.

2-1. Determine that provision in the market and/or commissioning of medical products for diagnosis of in vitro which underwent state registration are entered in the State register of medical equipment and products of medical prescription and are permitted for use in the territory of Ukraine and were introduced into circulation before date of obligatory use of the technical regulation, it is allowed without passing of assessment procedure of compliance and marking by national mark of conformity.

Such medical products for diagnosis of in vitro no more than five years from the date of issuance, without passing of assessment procedure of compliance and marking by national mark of conformity are allowed to provide in the market before the termination of term them to the validity, but.

2-2. Determine what for the period of operation of the Law of Ukraine "About introduction of amendments to some laws of Ukraine concerning ensuring timely access for patients to necessary medicines and medical products by implementation of public procurements with involvement of the specialized organizations conducting procurement" issuance and/or operation of medical products for diagnosis of in vitro which are subject to purchase according to the purchase agreements signed by the Ministry of Health with the specialized organizations which conduct procurements concerning which requirements of Items 10 - 13 Technical regulations are not fulfilled approved by this resolution is allowed on condition of recognition by the appointed conformity assessment body of results of the assessment of conformity which is carried out by foreign accredited bodies on assessment of conformity according to requirements of parts one and third article 45 of the Law of Ukraine "About technical regulations and assessment of conformity".

2-3. Determine that for the period of action of Item 71 of subsection 2 of the Section XX "Transitional provisions" of the Tax code of Ukraine and Item 9-6 of the Section XXI "Final and transitional provisions" of the Customs code of Ukraine, issuance and/or operation of medical products for diagnosis of in vitro included in the inventory (including medicines, medical products and/or the medical equipment), the actions, necessary for accomplishment, directed to prevention of origin and distribution, localization and liquidation of flashes, epidemics and pandemics of acute respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus which are exempted from payment of import duty and transactions on import to customs area of Ukraine and/or transaction on delivery of which on which customs area of Ukraine are exempted from the taxation by the value added tax, U-2116\224 approved by the resolution of the Cabinet of Ministers of Ukraine of March 20, 2020 \(The Official Bulletin of Ukraine, 2020, No. 26, the Art. 971), is allowed:

if they do not meet the requirements of the Technical regulation approved by this resolution; or

based on the notification of the Ministry of Health on issuance and/or operation of separate medical products for diagnosis of in vitro concerning which requirements of technical regulations are not fulfilled, but use of which is necessary for the benefit of health protection.

At the same time action of the Technical regulation approved by this resolution does not extend to medical products for diagnosis of in vitro on which such notification of the Ministry of Health is issued.

For issuance and/or operation based on the notification of the Ministry of Health of such medical products included in the specified list, the applicant submits to the specified body the application with indication of the purpose of issuance and/or operation, information on the producer, names of products, batch number or serial number, amount of batch, purpose of product and method of action. Also are enclosed to the application:

the document on compliance issued outside Ukraine (in case of availability);

the comfort letter of the applicant that assessment of conformity of medical products is not carried out.

By results of processing of the submitted documents Ministry of Health issues to the applicant the adequate notice. Consideration of documents and issue of the notification are performed on free basis.

2-4. Determine what issuance and/or operation of medical products for diagnosis of in vitro which are bought by person authorized on implementation of purchases in the field of health care according to the list determined by the Cabinet of Ministers of Ukraine concerning which requirements of Items 10 - 13 Technical regulations are not fulfilled, approved by this resolution, is allowed on condition of recognition by the appointed conformity assessment body of results of the assessment of conformity which is carried out by foreign accredited bodies on assessment of conformity according to requirements of parts one and third article 45 of the Law of Ukraine "About technical regulations and assessment of conformity".

2-5. Ceased to be valid according to the Resolution of the Cabinet of Ministers of Ukraine of 25.11.2022 No. 1317

3. Recognize invalid:

the resolution of the Cabinet of Ministers of Ukraine of July 16, 2008 No. 641 "About approval of the Technical regulation of rather medical products for laboratory diagnosis of in vitro" (The Official Bulletin of Ukraine, 2008, No. 53, the Art. 1773);

Item of 7 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of October 4, 2010 No. 902 (The Official Bulletin of Ukraine, 2010, No. 75, the Art. 2668);

Item of 6 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of November 16, 2011 No. 1171 (The Official Bulletin of Ukraine, 2011, No. 89, the Art. 3236)

Item of 3 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of August 28, 2013 No. 632 (The Official Bulletin of Ukraine, 2013, No. 69, the Art. 2533).

4. This resolution becomes effective in six months from the date of publication.

Prime Minister of Ukraine     

N. Azarov

     

Approved by the Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013, No. 754

The technical regulation of rather medical products for diagnosis of in vitro

General part

1. Action of this Technical regulation extends to medical products for diagnosis of in vitro and their supportive applications (further - products). For the purposes of this Technical regulation supportive applications are considered as medical products for diagnosis of in vitro.

This Technical regulation No. 98/79/EEC of rather medical products is developed for diagnosis of in vitro on the basis of the Directive of the European Parliament and the EU Council of October 27, 1998.

2. The terms used in this Technical regulation have the following value:

1) commissioning - readiness of product for the first use to destination;

2) issuance - the first emergence of product, except the products intended for clinical trials or assessment of characteristics in the market of Ukraine for the purpose of distribution and/or use to destination (on paid or free basis) irrespective of whether the product is new, or completely recovered;

3) product for self-checking - the medical product intended by the producer for independent use in house conditions;

4) the device intended for assessment of characteristics - the product intended by the manufacturer for carrying out over it one or more researches of product characteristics in the laboratories which are carrying out medical analyses or in other proper conditions outside its own rooms;

5) manufacturer - legal entity or physical person - the entrepreneur which is responsible for development, production, packaging and marking of product before its input in the address under own name irrespective of the specified actions by such person personally are made or to be effective with other person, the representative from his name.

Obligations of producers shall carry out also legal entities or physical persons - entrepreneurs who collect, pack, completely reconstruct and/or mark one or more finished products and/or determine their purpose as products for the purpose of introduction of such products in the address under own name, except persons who collect the product which is already extended in the market or adapt it for needs of the specific consumer;

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