Pharmaceutical Labeling from November 10, 2026: Prices With and Without VAT - FCHAIN

Pharmaceutical Labeling from November 10, 2026: Prices With and Without VAT

Starting November 10, 2026, updated Rules for the Labeling and Traceability of Medicinal Products will come into effect in Kazakhstan. The amendments, approved by an order of the Minister of Healthcare of the Republic of Kazakhstan, will affect manufacturers, importers, distributors, pharmacy chains, and other participants in the pharmaceutical market. One of the key changes is the requirement to indicate the price of medicinal products both including and excluding value-added tax (VAT) in certain documents within the Digital System for Labeling and Traceability of Goods (DSLTS). Additional amendments concern the registration of retail outlets, documentation of medicinal product receipt, registration of imported products, and management of labeling codes.

 

Indicating Pharmaceutical Prices With and Without VAT

From November 10, 2026, updated requirements for recording the prices of medicinal products will apply to documents processed through the DSLTS. In particular, certain documents will require two separate amounts instead of a single price per package: the price excluding VAT and the price including VAT. The new requirements apply to the following documents:

1. Notifications of medicinal product imports from EAEU countries and third countries — the price per package must be indicated both including and excluding VAT.
2. Acceptance and transfer certificates, including those issued by the Single Distributor — the price per package must be recorded separately with and without VAT.
3. Notifications of withdrawal of medicinal products from circulation — information on the price per package, including and excluding VAT, must be provided.
4. Notifications of reintroduction of medicinal products into circulation — the price per package must be indicated.
5. Internal transfer certificates, including those issued by the Single Distributor — information on the price per package is no longer required.

Pharmaceutical companies must therefore ensure that medicinal product prices are accurately reflected in their accounting records and labeling system documents. Particular attention should be paid to maintaining consistency between pricing information and VAT records.

 

Registration of Retail Outlets and Branches in the DSLTS

The updated rules introduce mandatory registration of territorially distributed units (TDUs) for participants in the pharmaceutical supply chain operating multiple branches or retail outlets under a single Business Identification Number (BIN) or Individual Identification Number (IIN). Each branch or retail outlet must be registered separately in the DSLTS, with its role specified according to the type of business activity. When medicinal products are transferred between units operating under the same BIN, the sender must prepare an internal transfer certificate, sign it using an electronic digital signature (EDS), and submit it to the system no later than the date of the transaction. These requirements are particularly relevant to pharmacy chains, distributors, and pharmaceutical companies with extensive branch networks.

 

New Deadlines for Acceptance and Withdrawal of Certificates

From November 10, 2026, the procedure for documenting the receipt of medicinal products in the DSLTS will change. The recipient must sign the acceptance and transfer certificate using an EDS and submit the relevant information to the system within one business day from the date of actual delivery, before conducting any subsequent operations involving the products. The rules for withdrawing documents will also be updated. The sender may withdraw an acceptance and transfer certificate before it has been confirmed by the recipient, without preparing a new document. The previous 20-business-day restriction will be removed. If discrepancies are identified during acceptance, the recipient must notify the sender accordingly. The system will then automatically cancel the original certificate, and the sender must prepare a new document. The following deadlines remain unchanged:

1. Notification of withdrawal of medicinal products from circulation — no later than three business days after withdrawal.
2. Submission of information on reintroduction into circulation — within three business days.

Companies should take these deadlines into account when organizing document workflows and coordinating operations between suppliers, warehouses, and retail outlets.

 

Withdrawal of Medicinal Products from Circulation

Pharmacies will continue to withdraw medicinal products from circulation during retail sales by scanning the labeling code on each package. Scanning equipment must be connected to a cash register. The labeling code is included in the fiscal receipt, after which the fiscal data operator transmits the relevant information to the DSLTS. If a customer pays for medicinal products through a bank transfer, the pharmacy must submit a notification of withdrawal from circulation. This notification must be submitted within three business days following the date of withdrawal.  The list of circumstances requiring such notifications has also been expanded to include:

1. Transfer of medicinal products to law enforcement and special government agencies.
2. Dispensing medicinal products under an insurance prescription.
3. Sale of medicinal products through non-cash payment.
4. Sale of medicinal products where the labeling code was not scanned.

Pharmacies should consider these changes when organizing retail transactions and documenting operations involving labeled medicinal products.

 

Changes for Pharmaceutical Importers

The updated rules introduce additional options for registering imported medicinal products in the DSLTS. Participants in the pharmaceutical supply chain will be able to register instances of existing product cards using their own importer information. In particular, they may update the importer’s IIN, BIN or TIN, company name, GCP, GLN, registered address, and business address. The existence of a product card with the same Global Trade Item Number (GTIN), previously registered by another participant, will no longer constitute an independent reason for rejecting registration. At the same time, an additional restriction will apply: registration will be refused if the state registration of the medicinal product or the authorization for a one-time import has been revoked, suspended, or expired. Foreign manufacturers, their representative offices and branches, and marketing authorization holders will be required to prepare a report on the transfer of identification codes to the importer. The report must be signed using an EDS and submitted to the DSLTS before the labeled products are transferred. A single aggregation code may contain no more than 5,000 labeling codes.

 

Requirements for Labeling Codes and Packaging

From November 10, 2026, the technical requirements for medicinal product labeling and transport packaging records will also be clarified. Batch numbers must contain only digits and Latin letters, without special characters. If an error in the batch number or expiration date is identified before the product is introduced into circulation, the participant may correct the information independently through the DSLTS online account. Once the medicinal product has entered circulation, corrections must be made through the Unified Labeling Operator. The DataMatrix code must consist exclusively of black-and-white elements. The rules for combining products into transport packaging will also change. Before products enter circulation, medicinal products with one or several GTIN codes may be combined into a single transport package. Disaggregation of transport packaging will be registered once all consumer packages or all nested transport packages have been removed. If only some nested transport packages are removed, the system will update the contents while retaining the original aggregation code, provided that no subsequent aggregation has taken place.

 

Which Medicinal Products Are Exempt from Labeling?

The updated rules expand the categories of medicinal products exempt from mandatory identification labeling. In particular, all radiopharmaceutical products will be exempt from labeling, regardless of where they are manufactured. Previously established exemptions will also remain in place for certain categories, including:

1. Medicinal products prepared in pharmacies.
2. Medicinal products manufactured in Kazakhstan exclusively for export.
3. Samples intended for expert examination and clinical trials.
4. Medicinal products manufactured or imported before mandatory labeling was introduced, which may continue to be sold until their expiration dates.

Access to Information in the Labeling System

The updated rules also clarify the system’s official designation. The former Information System for Labeling and Traceability of Goods (ISLTS) will be referred to as the Digital System for Labeling and Traceability of Goods (DSLTS). Additional provisions regulate access to information stored in the system. Such information is classified as restricted-access data. Supply chain participants will be able to access information relating to their own transactions, while manufacturers will have access to statistical and analytical data concerning their labeled medicinal products. Government authorities will receive information necessary to perform their statutory functions, and consumers will be able to access details about medicinal products, manufacturers, and sellers.

 

FChain Kazakhstan Services for Pharmaceutical Companies

Changes to pharmaceutical labeling regulations require companies operating in the sector to pay particular attention to accounting procedures, document management, and regulatory compliance. FChain provides professional services to pharmaceutical businesses in Kazakhstan, including:

1. Legal Support for Pharmaceutical Companies in Kazakhstan — legal advice on pharmaceutical business operations and compliance with industry-specific regulatory requirements.
2. Accounting and Tax Services — professional accounting and tax support, including accurate recording of pharmaceutical transactions and VAT.
3. Legal Audit — assessment of a company’s compliance with applicable regulations and identification of potential legal risks.
4. Accounting Recovery — correction of accounting errors, restoration of financial records, and improvement of accounting data accuracy.

The updated rules taking effect on November 10, 2026, will require manufacturers, importers, distributors, and pharmacies to review their internal procedures in a timely manner. Particular attention should be given to accurately recording pharmaceutical prices with and without VAT, meeting reporting deadlines, and properly documenting transactions in the DSLTS. Timely preparation for these requirements will enable pharmaceutical companies to reduce the risk of documentation errors, improve transaction transparency, and maintain compliance with the legislation of the Republic of Kazakhstan.

 

Legal News in Kazakhstan – November 2026

Prepared by: Anel Kosmaganbetova

Assistant to the Director

FChain Kazakhstan

 📩almaty@f-chain.com
WhatsApp: +7 771 214 1820