Placing, suspension, renewal or withdrawal of a medicine on the market

A marketing authorisation holder has a statutory duty to report the placement of a medicinal product onto the market in the Czech Republic and its suspended or terminated and subsequently resumed marketing.

Section 33, paragraph 2 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Pharmaceuticals”) stipulates the obligation of the marketing authorisation holder to report to SÚKL:

• The date of actual placement of a medicinal product on the market in the Czech Republic broken down by pack size and type of packaging; no later than two months after its actual placing on the market
• The date of suspension or termination of marketing of the medicinal product in the Czech Republic no later than two months in advance thereof; where exceptional circumstances arise, such notification may be made no later than concurrently with the actual suspension or termination of marketing of the medicinal product in the Czech Republic;
• Forthwith the date of resumed marketing of the medicinal product.

Section 33b para. 4 of the Medicinal Products Act further provides for the marketing authorization holder for a medicinal product for human use marked with the sign “restricted availability” pursuant to paragraph 2 to supplement the notification of the discontinuation of the marketing of the medicinal product for human use in the Czech Republic pursuant to Section 33 para. 2 with information on the measures taken to eliminate the reason for the discontinuation within 30 days from the date of the sign.

Use the following application on the SÚKL Access portal to send a report, view an overview of sent reports, edit them and send shortage mitigation plan:

login to the app

You can access the application using the authentication certificate that you already use when communicating with SÚKL, for example in REG-13 reporting, stock reporting or MAH11r. Access requests and their management are available at https://pristupy.sukl.cz/.

Reports on the placement of medicinal products on the market in the Czech Republic, suspension or termination of their marketing or their resumed marketing in the Czech Republic are published by SÚKL on an ongoing basis (please refer to the Overview of notifications) in order to provide the public with current information on the actual availability of medicinal products. These data are important especially for doctors to be able to secure the treatment of patients in clinical practice, for pharmacists in the dispensing of medicinal products and provision of relevant information to patients.

Please note that pursuant to Section 105, paragraph 5(c) of the Act on Pharmaceuticals, failure to comply with the above-mentioned notification duties may result in the marketing authorisation holder committing an administrative offence for which a fine of the max. of 2 000,000 CZK, pursuant to section 107, par. 1 (c )  of the Act on Pharmaceuticals, may be imposed.