➡️Medical Devices: Filling Out the Product Card

Специалист службы поддержки

To register consumer packaging of Medical Devices, the following steps must be completed:

When creating a product card with a local barcode (prefix 478), the corresponding GS1 prefix in the prefix table and confirmed GS1 membership are mandatory.
For imported products, it is mandatory to have a registered GTIN in the international GS1 database.

❗Filling out the product card in Uzbek and Russian languages is a mandatory requirement❗

Step 1.

1. Log in to the Goods Circulation Participant’s personal account ➡️ https://xtrace.aslbelgisi.uz/login-kep

2. Go to the "Product Descriptions" section ⬇️

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3. Click the "Create Product Description" button ⬇️

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4. Fill in the product information ⬇️

Basic Information:

Product Group – Medical Devices.
Product Category – Select from the dropdown list (according to the product being registered)
HS Code – Select from the dropdown list (according to the certificate of conformity).
Product Code (GTIN) – Enter the barcode (GTIN) printed on the product packaging.
Packaging Type – Unit of product (consumer packaging).

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5. Click the "Next" button

Step 2.
6. Select the marker ✅Mandatory fields

Basic product information:

SCP Code - select a value from the dropdown list.

Product Identifier:

Trade Name of the Product - You must specify the name of the drug, dosage form, and the number of units in the package.
Country of Manufacture - Select the country of manufacture of the medicinal product from the dropdown list/directory.

Conformity Documents:

Indication of the document’s indefinite validity

Manufacturer or Production Site:

Manufacturer’s name - provide the manufacturer’s data as indicated on the packaging and accompanying documentation.
Manufacturer’s location - provide the manufacturer’s data as indicated on the packaging and accompanying documentation.

Product Classification

Purpose or brief description - The information entered should be selected from the reference list and correspond to the instructions for use.
Product subposition in the IS "IKPU Register" - this is a detailed classification level in the Directory of Identification Codes of Products and Services (IKPU)

Regulatory Documentation

Regulatory document - Select from the dropdown list/directory according to the GOST document.

Description of the medicinal product packaging

Type of primary packaging - specify according to the instructions for use.
Number of units in the primary packaging - specify according to the instructions for use.

Organization accepting claims

Name of the organization accepting claims - specify according to the instructions for use.
Location of the organization accepting claims - specify according to the instructions for use.
Phone number of the organization accepting claims - specify according to the instructions for use.

Consumer Characteristics

Is sterile - The information entered must correspond to the data specified in the instructions for use of the medical device.
Expiration date - The information entered must correspond to the data specified in the instructions for use of the medical device.
Units of measurement - The information entered must correspond to the data specified in the instructions for use of the medical device.
Composition - The information entered must correspond to the data specified in the instructions for use of the medical device.

Manufacturer

Manufacturer’s name - provide the manufacturer’s data as indicated on the packaging and accompanying documentation.
Manufacturer’s location - provide the manufacturer’s data as indicated on the packaging and accompanying documentation.

Registration Certificate

Registration certificate number - Must be entered according to the registration certificate including letters and numbers.
Indication of indefinite validity - Must be entered according to the registration certificate. Select the correct option from the dropdown list/directory.
Name of the holder of the registration certificate - Must be entered according to the registration certificate.
Legal address of the holder of the registration certificate - Must be entered according to the registration certificate.
Tax identification number of the holder of the registration certificate - Must indicate the TIN of the holder of the registration certificate, obtained from the State Tax Committee of the Republic of Uzbekistan.