Pharma

Pharma serialization
in Uzbekistan

Regulator
CPRT Turon
System
ASL BELGISI (asllikbelgisi.uz)
Traceability
incomplete, applies to the list of pharmaceuticals set out in the Decree of the Cabinet of Ministers of the Republic of Uzbekistan No. 737 dated 20.11.2020 “On the introduction of the system of mandatory digital serialization for certain types of goods”. The list of transactions with pharmaceuticals that will be subject to mandatory data disclosure with the ASL BELGISI will be expanded at a later date.
Branding
standard GTIN (14 digits), SN- 13 digits, cryptographic part – verification key provided by the system operator – 4 characters and verification code generated by the system operator -44 characters).
What is required
to start serialization:
What is required
to start serialization:
List of local abbreviations
OMS - Orders management system
IGPC – individual group packaging code
TPVC – transport packaging verification code
UTD – Universal transfer document
DMC – DataMatrix code
CW – Customs Warehouse
Further development timeline
Pharmaceuticals in secondary packaging from 01.09.2022;
Pharmaceuticals in the original packaging from 01.10.2022;
Pharmaceuticals for orphan diseases and pharmaceuticals registered abroad from 01.03.2023;
Medicine under the list compiled by the Ministry of Healthcare from 01.02.2025.
Pharma serialization in Uzbekistan
Reporting process
For local manufacturers
Order of the DataMatrix codes
The manufacturer orders unique serial numbers with each unit crypto-coded in accordance with the production plan via OMS in the NIS MPT.
1
Utilization of DataMatrix codes
If serialization is done in the course of production, the serial numbers are coded in the DataMatrix format with a view to subsequently applying them to individual consumer packaging. At the end of production data on the completion of this stage are transferred to OMS.
2
Aggregation (mandatory from June’ 01’ 2023)
Units are aggregated into factory or transportation packings which are then aggregated to pallets. Each aggregation is assigned a unique code SSCC GS1-128 by the manufacturer; codes comprise hierarchies. Each DataMatrix code with a hierarchical structure is saved in a private repository and is transferred to OMS.
3
Release into circulation
When the goods are manufactured, and quality control procedure is over the manufacturer uploads to the NIS MPT the information about serialized goods release into circulation.
4
Dispatch to a new owner
Each serialized package is scanned, the unique codes are transferred to an electronic invoice (EDI) operator. The NIS MPT receives from the EDI operator information on the transfer of title to the goods along with the codes. In the course of acceptance of the serialized goods receiver scan each transportation unit or packing in order to verify that it corresponds to the one entered into the incoming UTD. Title is transferred after the execution of the UTD. The title transfer is registered with the NIS MPT.
5
Withdrawal from circulation
As the serialized packings are sold in retail stores, the DataMatrix code is scanned for the consumer, the unique serial numbers are entered into the electronic cash receipt, subject to subsequent transfer to the NIS MPT via a fiscal data operator.
6
Inspection of the product by the end consumer
Any consumer may scan the DataMatrix code via a mobile app called ASL Belgisi in order to check the authenticity of the product and to learn more about its origin.
7
Reporting process
For importers
Order of the DataMatrix codes
The importer / representative of the manufacturer orders unique serial numbers crypto-coded for each unit in accordance with the production plan. The serial numbers and crypto-codes are ordered through the OMS. Further, ordered serial numbers are transferred to the manufacturer for products serialization.
1
Utilization of DataMatrix codes
If serialization is done in the course of production, the serial numbers are coded in the DataMatrix format with a view to subsequently applying them to individual consumer packaging. At the end of production data on the completion of this stage are transferred to OMS.
2
Aggregation (mandatory from June 01’ 2023)
Units can be aggregated into factory or transportation packings which are then put onto pallets. Each aggregation is assigned a unique code SSCC GS1-128 by the manufacturer; codes comprise hierarchies. Each DataMatrix code with a hierarchical structure is saved in a private repository and is transferred to OMS.
3
Serialization at the Customs Warehouses
Serialization and aggregation can also occur at a Customs Warehouse. The complete code hierarchy must be uploaded to the IS MPT before the goods are cleared through the customs.
4
Imports
The importer or a customs broker applies a freight customs declaration (FCD) to the State customs committee of the Republic of Uzbekistan, that, in turn, clears the goods and authorizes the imports of the goods into Uzbekistan. After the serialized goods pass through customs the importer upload a specialized report to the NIS MTP, which constitutes product release into circulation.
5
Dispatch to a new owner
Each serialized package is scanned, the unique codes are transferred to an electronic invoice (EDI) operator. The NIS MPT receives from the EDI operator information on the transfer of title to the goods along with the codes. In the course of acceptance of the serialized goods receiver scan each transportation unit or packing in order to verify that it corresponds to the one entered into the incoming UTD. Title is transferred after the execution of the UTD. The title transfer is registered with the NIS MPT.
6
Withdrawal from circulation (mandatory from 2023)
As the serialized packages are sold in retail stores, the DataMatrix code is scanned for the consumer, the unique serial numbers are entered into the electronic cash receipt, subject to subsequent transfer to the NIS MPT via a fiscal data operator. It is also possible that the goods may be withdrawn as they move down the supply chain due to damage, expiration, destruction etc. All the relevant changes are entered into the repository and are uploaded to the NIS MPT.
7
Inspection of the goods by the end consumer
Any consumer may scan the DataMatrix code via a mobile app called ASL Belgisi in order to check the authenticity of the product and to learn more about its origin.
8
What is required from the manufacturer (foreign MAH)?
After 01/09/22 a manufacturer (foreign MAH) should:
Option 1. Without opening the “Accredited representative office”
Step 1. Getting TIN (tax number) for MAH from Uzbekistan authorities
Step 2. Getting personal tax ID (PINFL) of the representative and the electronic signature form embassy
Step 3. Register in ASL Belgisi and product description in National catalogue
Step 4. Internal technical and IT preparations required to manage codes emission and application.
Step 5. Before 01/09/23 to sign an agreement with local company to represent its medicines in case of complaints or for interaction with the Regulator Authorities.
Option 2. To open the “Accredited representative office” (such form of legal entity) and delegate it all the tasks related to the serialization and regulatory issues.
What are the steps for getting TIN for MAH?
MAH need to provide a package of documents to the State Tax Committee for registration of a non- resident TIN. The procedure is carried out only on behalf of a non-resident.
List of required documents:
  • A document confirming the official
  • registration in the country of the non- resident's location, issued by the relevant state authority (certificate of state registration or extract from the state registry);
  • Documents confirming the individual taxpayer number of MAH according to the legislation of the origin country.
  • A copy of the passport of the head, or an authorized person;
  • A power of attorney issued to the authorized person, indicating the full passport data and the powers granted to him (notarized) including the power to receive TIN from embassy;
  • Registration certificate of the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment of the Republic of Uzbekistan.
What are the steps for getting personal tax ID (PINFL) of the representative and the electronic signature form embassy?
  1. Get an electronic version of the certificate of state registration with the State Tax Committee;
  2. Contact the nearest consulate or Embassy of the Republic of Uzbekistan. Documents required:
  3. a) certificate of state registration;
  4. b) a notarized power of attorney;
  5. c) passport
  6. d) a photo for PINFL (at least 297x382 pixels);
  7. e) payment document on payment of the fee
  8. for the issuance of an electronic digital signature key certificate (to be paid at the consulate);
  9. Issue a PINFL (Personal Identification Number of an individual);
  10. Receive an EDS key certificate file and the EDS key file itself (the password will be sent to the email address specified in the application);
Attention: the passport data of the authorized person must be correctly reflected in the power of attorney, while the power of attorney must specifically state that this person has the right to apply to the consulate to obtain an EDS.
Is it possible to provide a power of attorney to an employee of an MAH subsidiary company and authorize him to receive a TIN and interact with the Uzbekistan Embassy to obtain MAH Electronic Signature in another country? For example, a subsidiary of a German manufacturer, locates in Russia will help MAH to receive its TIN and EDS at the embassy in the Russian Federation?
This option is possible. The power of attorney should be issues by MAH for that employee.
If manufacturer produces medicines for a local company who is in charge of customs?
If you are a contract manufacturer (CMO), you should receive codes from MAH. It means that the local company (if they are MAH) should do all serialization tasks and either provide you with crypto-codes forapplication, or applycrypto-codes at customs warehouse by themselves.

What if the exclusive distributor for UZB is not MAH and there is no Representative office of the manufacturer in UZB and the modus operandi of a manufacturer/MAH does not include the opening of R.O. In Uzb, how can we as exclusive distributor get the codes?
At the moment, getting EDS and crypto-codes is MAH responsibility. As a distributor you should receive a serialized product according to Uzbekistan regulations from MAH. MAH should get the electronic signature, describe their products in National Catalogue and apply codes on the packs.

If there is no technical possibility to apply codes on the plant, you can integrate your T&T system with distributors T&T system and manage the crypto- ordering process by your distributor on behalf of MAH, using this integration.
If a foreign MAH provides a notarized and apostilled PoA to local legal entity, then can the company/partner from Uzbekistan order codes?
MAH have to order crypto-codes by itself (using an electronic signature), there is no possibility to delegate it to a local company, unless you have integration between your T&T systems and their request may be executed by your T&T.
Do companies need to pay for crypto codes for testing? Can we setup Test Materials with test GTINs in the UZ Production system?
There is no need to pay for crypto-codes before the serialization start date (01 Sep). As there is no test environment in ASL Belgisi, testing in Production environment is the only available option. To avoid any problems, you can choose a reliable integrator supplier.
All CC provided from OMS will be seen as applied in the system. Is it mandatory to report the CC that is printed but will never meet the UZ marked due to internal sampling or internal scrapping? No commissioning report is needed, right?
It is not mandatory to report commissioned CC that were sampled or scrapped at least until Aggregations aremandatory. No commissioning report is required.

Will the serialsand cryptos be generated automatically by the system whenwe order the codes or do we need to identify an algorithm to the system?
There are two options to generate serial number: it can be issued by ASL Belgisi, OR (and usually second option is more preferable) they may be issued by your Track&Trace system. Generally. For some Track&Trace providers it may be challenging task because some symbols (characters) are not supported. Our solution (Utrace HUB) can deal with this task and provide SN generations before sending a request to ASL Belgisi by the algorithm specified by you.
Is it only MAH who can add master datato the National Catalogue?
Yes. All data added to the National Catalogue require signing by the MAH electronic signature.
Can non-serialized products be put into circulation until 03.2023?
Yes, and after certification you can sell them until August 2025.
When companies ship the goods from outside UZ to custom warehouse should they report that movement and to where? Or is the SCN to our partnerenough?
No, there is no MOVE report in ASL Belgisi. Your internal shipping notification will be enough
About recognitions of Russian MDLP codes in Turon system. As one of steps - we must declare exact codes to Turon system to transfer them from MDLP to Turon. At this step will it be enough to declare only SGTIN (Gtin+serial) or we must declare whole crypto code (gtin+serial+crypto parts)?
The mutual recognition requires an “inter- operators’ agreement”. Currently CPRT Turon is working out this agreement with CRPT Russia. This process is expected to finalized in July, and necessary documentation will be issues.

When does serialization start for mutually recognized meds in foreign packs? I don't see it on the timeline. Will foreign digital marking (Germany, Spain) be recognized?
The mutual recognition requires an “inter- operators’ agreement”. Currently CPRT Turon is working out this agreement with CRPT Russia. This process is expected to finalized in July, and necessary documentation will be issues.

EU FMD serialization will not be recognized in the nearest perspective.
Is it correct, that there won`t be any human readable prefixes for product code / GTIN and serial number?
The requirement for human-readable information exists only in case you apply data matrix on the stickers. The serial number and GTIN are required.

When DM is applied directly to the package, only the information required by law is required: series, date, expiration date. Serial number and GTIN is
optional.
What are the timelines for commission, aggregation and shipment report submission?
There are no obligatory deadlines for reporting. Shipment report should not be submitted by importers.
When the list of the local entities that we can delegate the serialization will be available? (Authorized companies that could proceed with the serialization and have the customs capability)
The process in discussion at the Customs Committee, we expectsome information by the second half of July.

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