MDLP Aggregation for Pharma Distributors. How to Report Transport Packaging Operations and Avoid Fines
The exact same situation occurs daily at a pharmaceutical warehouse. A pallet arrives from the manufacturer, but two boxes need to be shipped to different clients. A standard warehouse operation turns into a regulatory task: since July 1, 2020, any opening of a transport package requires reporting to the Monitoring System for the Movement of Medicines (MDLP). For violating the procedure for submitting information, Article 6.34 of the Code of Administrative Offenses of the Russian Federation prescribes fines of up to 100,000 ₽ for legal entities. Operators of large warehouses handling thousands of pallets per month constantly face the need to establish a clear process for interacting with the labeling system.
We analyze which operations with transport packaging require reporting, which XML schemas to use, and how to avoid product blocking.
How Things Worked Before Mandatory Labeling
Prior to the implementation of the MDLP, distributors operated transport packages without digital reporting. They accepted a pallet, broke it down into boxes, shipped them to clients, and entered the data into the warehouse management system (WMS). Traceability was ensured by paper documents and medicine batch numbers.
During the initial phase of the labeling rollout in 2019–2020, a notification-based regime was in place. The MDLP system recorded operations but did not block product movement when errors occurred. Distributors could experiment with data exchange schemas and correct inaccuracies after the fact.
Since September 1, 2023, the notification regime has completely ended. The MDLP now operates in full compliance mode. If information is submitted incorrectly or out of sequence, the system blocks further operations with the medicine. The list of reasons for blocking is provided in Appendix No. 7 to Government Decree of the Russian Federation dated December 14, 2018, No. 1556 (hereinafter — PP No. 1556).
Four Operations with Transport Packaging
PP No. 1556, in its current revision, establishes an exhaustive list of operations with transport packaging that require reporting to the MDLP. Appendix No. 5 describes four types of operations.
| Operation | MDLP Schema | Essence of the Operation | Example of Application |
|---|---|---|---|
| Aggregation | 911 / 915 | Packages are combined into transport packaging | Forming a box or a pallet |
| Disaggregation | 912 | Transport packaging is completely dismantled | Opening a box for separate shipment |
| Extraction | 913 | Part of the packages is removed from the transport packaging | Partial picking from a box |
| Addition | 914 | Packages are added to existing transport packaging | Topping up a box |
Schema 911 is used to combine secondary (consumer) packages into a single transport container with a new SSCC code. Schema 915 allows for bulk aggregation into multiple transport packages in a single operation, which is convenient when dealing with large batches.
Schema 912 is designed for complete disaggregation. After successful processing, the SSCC becomes free and can be reused. When disaggregating, the type can be specified: down to the level of secondary packaging or only to the next level of nesting.
Schema 913 is required to extract individual packages from a box without dismantling the box itself. A typical example: a client ordered 50 packages, but there are 100 in the box. Schema 914 allows adding packages to an already formed box.
Restrictions on Batch and GTIN
Clause 40 of PP No. 1556 establishes a restriction: only medicines with the same Global Trade Item Number (GTIN) and the same manufacturing batch number can be aggregated. Different medicine names, the same medicine in different dosages, or the same item from different manufacturing batches cannot be placed into a single box.
If a warehouse needs to form a mixed shipment of different items, each item is aggregated separately. The boxes are then combined on a pallet as a second level of aggregation.
Timeframes for Submitting Information
Clauses 40 and 41 of PP No. 1556 establish a general principle: information on aggregation, disaggregation, extraction, or addition must be submitted before presenting information on subsequent operations with these medicines or the transport packaging. Specific timeframes in working days are established for turnover operations, not for transport packaging operations.
| Operation | Timeframe for Submission |
|---|---|
| Aggregation, disaggregation, extraction, addition | Before presenting information on subsequent operations |
| Acceptance from a supplier (schemas 701, 416) | 1 working day from the date of acceptance |
| Internal transfer between places of business activity (schema 431) | 5 working days |
| Shipment to a counterparty (schema 415) | 1 working day from the date of shipment |
Timeframes for turnover operations are specified directly in PP No. 1556 (Clauses 43, 44). The Methodological Guidelines for Working with Labeled Medicines additionally indicate an approximate timeframe of up to 1 working day for aggregation within the Russian Federation and up to 20 working days outside the Russian Federation.
The Principle of Sequentiality
Clause 32 of PP No. 1556 establishes the principle of sequentiality: information on the next operation with a medicine is transmitted only after receiving confirmation of the successful processing of information on the previous operation.
In practice, it works as follows. The warehouse sends an XML document via schema 912 (disaggregation). The MDLP processes the document and returns a receipt. Only after receiving a successful receipt can schema 415 (shipment) be sent. If the shipment is sent before receiving the receipt for disaggregation, the system will issue an error or block the operation due to Reason No. 4 of Appendix No. 7: no information confirming that the medicine is in the possession of the supply chain participant.
The SSCC and Its Structure
The Serial Shipping Container Code (SSCC) is a unique identifier for transport packaging. In Clause 10 of PP No. 1556, it is referred to as the identification code of the tertiary (transport) packaging of a medicine. The structure of the code is regulated by GOST ISO/IEC 15417-2013 and consists of 18 digits.
| Component | Description |
|---|---|
| Application Identifier (00) | Indicates the SSCC data type |
| Extension Digit | From 0 to 9, used to increase numbering capacity |
| GS1 Company Prefix | Unique organization number from the GS1 information resource, 7–9 digits |
| Serial Reference | Sequential number of the transport unit from the internal WMS |
| Check Digit | Calculated using the Modulo-10 algorithm to verify scanning accuracy |
The code is applied as a linear Code 128 barcode. An SSCC can be generated by the manufacturer when forming factory boxes, by the distributor during re-aggregation at their warehouse, or by any turnover participant registered in the GS1 system. Membership in GS1 Russia is required for generation. The membership fee depends on the company’s turnover and starts from 15,000 ₽ per year.
The Methodological Guidelines recommend marking the SSCC label with additional text such as «Labeling» or «MDLP» so that warehouse personnel can distinguish this code from other logistical barcodes. A single box may carry several different barcodes: the manufacturer’s EAN-13, an internal warehouse number, or a batch code. Visually identifying the SSCC speeds up operations and reduces the risk of scanning errors.
It is recommended to apply two SSCC labels on adjacent vertical sides of the box. When placed on a pallet, boxes are positioned so that the SSCC faces outward. Nesting is best kept to two levels: the transport box and the pallet. Applying a separate SSCC to a shrink-wrapped bundle of 3–5 packages is not recommended, as it complicates inventory accounting without practical benefit.
A manufacturer or supplier may physically apply an SSCC to the packaging but fail to report the aggregation to the MDLP. When scanning such an SSCC at a distributor’s warehouse, the system will find no information about its contents. The contents of an SSCC can be verified via the API method /reestr/sscc/sscc_check, the analytical data task sscc_hierarchy, or schemas 210/220. If the SSCC is not registered in the MDLP, the distributor will have to work with the goods at the level of individual Serialized Global Trade Item Numbers (SGTIN), scanning each package separately.
Direct and Reverse Acceptance Upon Receipt
When receiving goods from a supplier, the distributor chooses one of two procedures for submitting information.
With direct acceptance, the supplier first registers the shipment via schema 415. The MDLP puts the goods into a status pending confirmation. The distributor confirms receipt via schema 701, and the goods are transferred to their balance. Under this procedure, the distributor cannot perform any operations with the goods — including disaggregation — until they receive a notification from the supplier via schema 607 and confirm the receipt.
With reverse acceptance, the distributor first registers the receipt via schema 416. The MDLP puts the goods into a status pending confirmation by the sender. The supplier confirms the shipment via schema 607, and the goods are transferred to the distributor’s balance. For reverse acceptance, the distributor must be added to the supplier’s registry of trusted counterparties.
Sometimes a supplier fails to confirm the shipment on time, but the distributor already needs to sell the goods. For such cases, a pending registry mechanism is available. After submitting schema 416 within the established timeframe, the distributor can withdraw the goods from circulation through retail sale or medical use. The labeling code enters the pending registry. The maximum waiting period for confirmation from the supplier is 7 working days, after which the information is forwarded to Roszdravnadzor as a violation.
Typical Errors When Working with Transport Packaging
Violation of the sequentiality of operations manifests as the error «identification code not on balance» or a system block. The warehouse attempts to ship goods before receiving the receipt for disaggregation of the transport packaging. The MDLP does not yet see that the packages have been released from the box and considers them unavailable for shipment. The solution is to configure the WMS so that shipment is blocked until a successful receipt for transport packaging operations is obtained. Many modern systems support an automatic queue mode, where the next document is sent only after receiving a successful response to the previous one.
Aggregating different batches leads to rejection of the document submitted via schema 911. Medicines from different manufacturing batches ended up in the same box, which directly contradicts Clause 40 of PP No. 1556. Before aggregation, verify that all packages belong to the same batch and automate this check in the WMS. Some warehouses add a verification step before forming a box: the operator scans the first package and the system remembers the batch. Any attempt to add a package from a different batch triggers a warning.
Extracting from different boxes in a single operation also results in rejection of the document submitted via schema 913. Attempting to extract labeling codes from different group packages using a single XML document is not permitted by the schema structure. A separate document must be generated for each box from which extraction occurs. If a client’s order is fulfilled from three different boxes, three documents via schema 913 must be sent to the MDLP.
Skipping a nesting level causes an error when extracting packages from a pallet. Where multiple nesting levels exist, extraction must be performed sequentially. First, the box is extracted from the pallet via schema 913, specifying the SSCC of the box. Then, the packages are extracted from the box in a separate operation using the same schema 913, this time specifying the SGTIN labeling codes. Each operation is recorded in the MDLP separately and requires its own receipt.
Lack of balance verification results in the error «code not on balance.» The goods have either not been accepted via schema 701 or 416, or the previous operation has not been processed. Before any operation, check the status of the goods via the API or the MDLP account. This error occurs most frequently with reverse acceptance, when the distributor registers receipt before the supplier has sent the shipment notification.
Penalty Sanctions
Administrative liability for violations in the field of medicine labeling is governed by a special provision: Article 6.34 of the Code of Administrative Offenses of the Russian Federation. This article was introduced specifically for the pharmaceutical industry and takes precedence over general regulations on product labeling.
| Violation | Officials | Legal Entities | Confiscation |
|---|---|---|---|
| Production or sale without labeling or in violation of the labeling procedure (Part 1) | 5,000–10,000 ₽ | 50,000–100,000 ₽ | Yes |
| Untimely submission of data to the MDLP or submission of inaccurate data (Part 2) | 5,000–10,000 ₽ | 50,000–100,000 ₽ | No |
Part 2 of Article 6.34 directly applies to operations involving transport packaging. If a distributor fails to submit information on disaggregation on time or specifies incorrect labeling codes, this provision is applied.
Article 15.12.1 of the Code of Administrative Offenses establishes a general rule for violating the procedure and timeframes for submitting information to the monitoring system operator: a warning or a fine of 1,000–10,000 ₽ for officials, and 50,000–100,000 ₽ for legal entities. For medicines, Article 6.34 takes precedence as a special provision.
What to Do
Check WMS integration with the MDLP. Ensure the warehouse management system correctly generates XML documents per schemas 911–915, processes receipts, and blocks subsequent operations until confirmation is received. Automatic batch verification during aggregation will prevent document rejections.
Obtain GS1 membership if you plan to form your own transport packages with SSCC codes. Registration is available at gs1ru.org. The membership fee starts from 15,000 ₽ per year and grants a company prefix for SSCC generation.
Develop an internal regulation with step-by-step procedures for warehouse personnel. Upon receipt: define which acceptance procedure to use and how to verify the SSCC. Upon disaggregation: specify which schema to apply and how to confirm the operation was successful. When forming a shipment: establish how to aggregate and which checks to run.
Train personnel on working with 2D code scanners, on the difference between a DataMatrix code (labeling code) and a linear barcode (SSCC), and on the correct course of action when MDLP errors occur.
Set up operations monitoring. Run a daily check of the pending registry, monitor rejected documents, and correct errors promptly. Clause 52 of PP No. 1556 allows corrections to be made before an inspection by Roszdravnadzor is scheduled.
Estimated costs for a distributor: WMS integration from 50,000 ₽ if a ready-made module is available; GS1 membership from 15,000 ₽ per year; data collection terminals with 2D scanners from 30,000 ₽ per device.
Regulatory Framework:
1. GOST ISO/IEC 15417-2013 «Information Technology. Bar code symbology specification. Code 128»
2. Decree of the Government of the Russian Federation dated December 14, 2018, No. 1556 «On Approval of the Regulation on the System for Monitoring the Movement of Medicines for Medical Use»
3. Federal Law dated April 12, 2010, No. 61-FZ «On the Circulation of Medicines»
4. Code of Administrative Offenses of the Russian Federation, Articles 6.34, 15.12.1
5. Methodological Guidelines for Working with Labeled Medicines (Version 1.8)