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:
to start serialization:
What is required
to start serialization:
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
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.
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
For local manufacturers
- Order of the DataMatrix codesThe 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 codesIf 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 circulationWhen 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 ownerEach 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 circulationAs 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 consumerAny 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
For importers
- Order of the DataMatrix codesThe 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 codesIf 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 WarehousesSerialization 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
- ImportsThe 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 ownerEach 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 consumerAny 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
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.
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.
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:
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.
- Get an electronic version of the certificate of state registration with the State Tax Committee;
- Contact the nearest consulate or Embassy of the Republic of Uzbekistan. Documents required:
- a) certificate of state registration;
- b) a notarized power of attorney;
- c) passport
- d) a photo for PINFL (at least 297x382 pixels);
- e) payment document on payment of the fee
- for the issuance of an electronic digital signature key certificate (to be paid at the consulate);
- Issue a PINFL (Personal Identification Number of an individual);
- 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);
This option is possible. The power of attorney should be issues by MAH for that employee.
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.
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 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.
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.
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.
It is not mandatory to report commissioned CC that were sampled or scrapped at least until Aggregations aremandatory. No commissioning report is required.
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.
Yes. All data added to the National Catalogue require signing by the MAH electronic signature.
Yes, and after certification you can sell them until August 2025.
No, there is no MOVE report in ASL Belgisi. Your internal shipping notification will be enough
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.
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.
EU FMD serialization will not be recognized in the nearest perspective.
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.
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.
There are no obligatory deadlines for reporting. Shipment report should not be submitted by importers.
The process in discussion at the Customs Committee, we expectsome information by the second half of July.