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On 17 February 2026, the State Institute for Drug Control (SÚKL) issued a notice reminding medicinal product distributors of their legal obligations when notifying the intention to distribute human medicinal products abroad.
The reminder applies specifically to products included in the list established under Section 77c of Act No. 378/2007 Coll., on Medicinal Products, as amended. These are medicines identified as critical to ensuring treatment availability for patients in the Czech Republic.
Export Notification Requirements (Form DIS-18)
Distributors intending to export a listed human medicinal product must submit an electronic notification via the DIS-18 web form.
In accordance with Section 77(1)(q) of the Act on Medicinal Products, the notification must include:
- Identification details of the distributor
- Identification of the human medicinal product
- Quantity to be distributed (in units of measurement)
- Destination country
- Planned date of distribution
The distributor may proceed with the intended export only after 15 working days have elapsed from the date of notification, unless a general measure under Section 77d is issued during this period.
Non-Compliance Risks
SÚKL emphasized that if the export does not occur on the originally announced date or is only partially carried out, the distributor cannot simply transfer the remaining quantity to a later period. In such cases, a new notification must be submitted.
Failure to comply with these obligations constitutes a violation under Section 77(1)(q) and may qualify as an administrative offense under Section 105(2)(r) of the Act on Medicinal Products.
Penalties may include fines of up to CZK 20 million.
Regulatory Context
The notification requirement applies only to medicinal products included in the Section 77c list by the Ministry of Health of the Czech Republic. These are products whose shortage could jeopardize treatment availability or patient care within the country.
The measure forms part of broader safeguards aimed at protecting domestic supply chains and ensuring the continuous availability of essential medicines.
For distributors operating across multiple jurisdictions, maintaining compliance with evolving Good Distribution Practice (GDP) and export notification requirements remains critical to avoiding regulatory exposure and financial penalties. Structured regulatory support and lifecycle compliance oversight can assist companies in managing cross-border obligations effectively.
For more information: Information for distributors distributing medicinal products abroad
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