Reporting of suspected falsified medicinal product
The forms below are intended only for reporting suspected counterfeit products from the legal distribution chain, e.g. from a pharmacy or medical facility.
- What is a falsification or counterfeit?
- Who’s reporting?
- How to report?
- Where to report?
- Why to report?
COUNTERFEIT
According to the Medicines Act, a counterfeit medicinal product is any medicinal product for human use,
- bearing false statements as to its identity, including its packaging and labelling, name or composition in respect of any of its ingredients, including excipients and the strength of those ingredients,
- bearing false information about its origin, including the manufacturer, country of manufacture, country of origin or marketing authorisation holder; or
- which is accompanied by documentation containing false information about its history, including records and documents relating to the distribution channels used.
- which was stolen, disrupting the legal distribution chain. The quality, efficacy and safety of such a medicinal product is not guaranteed and it is considered counterfeit when it is put back on the market.
A medicinal product with unintended quality defects is not considered a falsified medicinal product.
WHO IS REPORTING
According to Article 23(1)(f) of the Medicinal Products Act, the operator is obliged to notify the CMA of a suspicion of a counterfeit medicinal product, see the folowing link (only in czech language:
However, anyone who encounters a medicinal product package that meets any of the above criteria may report a suspected counterfeit.
HOW TO REPORT
There are several ways to report a suspected counterfeit medicine from the legal distribution chain.
1) Preferably by completing the electronic form for reporting suspected counterfeit medicines:
The form will be sent to the Department of Quality Defects, SÚKL and a PDF version will be sent to the email address you provided.
2) Filling out the form in Word format:
3) by sending an email with a description of the suspected falsified medicinal product, preferably including photographs.
The State Institute for Drug Control processes the data provided for the purpose of recording and processing reports of suspected counterfeit products on the basis of Section 13(2)(c) and (e) of Act No 378/2007 Coll., on Medicinal Products. Further information on the processing of personal data, in particular on your rights, such as the right of access and the right to object, can be found on the website (only in czech language) through the link at the botom of this page.
WHERE TO REPORT
Address for sending the printed form and, if applicable, a sample of the suspected quality defect:
- e-mail address: zavady@sukl.gov.cz (send as attachment)
- postal address:
State Institute for Drug Control
Department of Quality Defects
Šrobárova 48
100 41 Prague
If you have any questions, please contact us at:
- E-mail address: zavady@sukl.gov.cz
- telephone 272 185 363, 272 185 123, 272 185 258
WHY TO REPORT
Counterfeit medicines pose a serious threat to public health. It is essential to prevent these counterfeit medicines from entering legal supply chains, pharmacies and hospitals and to protect the public from purchasing these counterfeit medicines.