Search on the web…
Homepage Reporting Reporting of stocks of medicinal products

Reporting of stocks of medicinal products

The State Institute for Drug Control issues requests for data submission in case of suspected threats to the availability of medicinal products for human use to the following entities:

  • marketing authorisations holders pursuant to the provisions of Section 33 para. 2 sentence 6 of Act No 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended,
  • distributors of medicinal products pursuant to the provisions of Section 77 para. 1 letter f) of Act No 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended, in conjunction with the provisions of Section 35e of Decree No 229/2008 Coll., on the Manufacture and Distribution of Medicinal Products, as amended,
  • to providers authorised to dispense medicinal products pursuant to the provisions of Section 82 para. 3 of Act No 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended, in conjunction with Section 38c of Decree No 84/2008 Coll., on Good Pharmacy Practice, Detailed Conditions for the Handling of Medicinal Products in Pharmacies, Health Care Facilities and Other Operators and Facilities Dispensing Medicinal Products, as amended.

Reporting of stocks can be sent to SÚKL only electronically, using:

  1. the web API or a connector in the information system of the pharmacy, distributor or marketing authorisation holder, located at https://api.sukl.cz/. All API documentation is available at https://testapi.sukl.cz/, HSZ (Iventory reporting) block. To use the web-based API, please contact your software provider.
  2. the web application, which is hosted on the SÚKL portal https://pristupy.sukl.cz/#anchor_hlaseni_pro_sukl, reporting section, Iventory reporting block. An authentication certificate is required to send the report, which is currently already used by all pharmacies, distributors and marketing authorisation holders when communicating with SÚKL. The reporting procedure is explained in the video tutorial (CZ only).

If the call to the marketing authorisation holder includes a requirement to send a supply plan, the completed table in XLS format is sent by e-mail to marketreport@sukl.gov.cz.

The individual notices shall contain a justification of the reasons for which the SÚKL suspects that the availability of the medicinal products in question is at risk and proceeds to issue the relevant notice. The individual calls are delivered to the marketing authorisation holders, and in the case of calls to distributors of medicinal products and providers authorised to dispense medicinal products, the individual calls are published for the duration of their validity in the Stock Reporting Calls.

In case of confusion and questions: