DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 26

About special sign of the address of medical products in the market of the Eurasian Economic Union

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, item 4 of article 7 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 94 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 109:

1. Approve enclosed:

the image of special sign of the address of medical products in the market of the Eurasian Economic Union;

Regulations on special sign of the address of medical products in the market of the Eurasian Economic Union.

2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 26

Regulations on special sign of the address of medical products in the market of the Eurasian Economic Union

1. This Provision is developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, item 4 of article 7 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, and establishes procedure for use of special sign of the address of medical products in the market of the Eurasian Economic Union (further respectively - special sign of the address, medical products, the Union).

2. The special sign of the address demonstrates that the medical product marked by it underwent the procedure of registration and confirmation of conformity established within the Union to general requirements of safety and efficiency of medical products and requirements to implementation and maintenance of quality management system of medical products.

3. The abbreviation of EAS means Eurasian compliance (Eurasian Conformity).

4. Marking of medical product special sign of the address is performed by the producer of this medical product or its authorized representative.

5. Marking by special sign of the address is performed before release of medical product in the address within the Union.

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 26

The image of special sign of the address of medical products in the market of the Eurasian Economic Union

I. The description of the image of special sign of the address of medical products in the market of the Eurasian Economic Union

The image of special sign of the address of medical products in the market of the Eurasian Economic Union (further - special sign of the address) represents square contour with entered in it the symmetry centered on vertical axis by abbreviation of EAS which is formed by combination of three stylized letters of the Latin alphabet "E", "A" and "C" which are graphical performed using the right angles having the identical height and width and repeats exact proportions of square on light (fig. 1) or contrast (fig. 2) background.

The image of special sign of the address shall be one-color and contrast with color of surface on which it is applied.

Width of the line of elements of abbreviation of EAS is equal to width of the line of contour of square.

In the lower part the contour is disconnected, the text of MED which is reducing the word "medical" ("medical") is entered in disconnection. The text consists of three letters of the Latin alphabet "M", "E", "D" centered on vertical axis of symmetry. Width of the line of elements of text of MED constitutes 1/2 width of contour of square. The horizontal axis of symmetry of text of MED matches with horizontal axis of symmetry of width of the lower contour of square.

II. Sizes and proportions of special sign of the address

The image of special sign of the address on large-scale grid with indication of the sizes and proportions is provided in the figure 3.

The main proportions of special sign of the address on large-scale grid: the size down H - 30a, the size across B - 28a where "an" is the razmeroobrazuyushchy module.

The sizes of special sign of the address when scaling are determined by pro rata change of the sizes H and B.

Admissible minimum value of the size B - 6 mm.

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