Reporting a suspected quality defect of medicines
- What is a quality defect?
- Who’s reporting?
- How to report?
- Where to report?
- Why to report?
QUALITY DEFECT
A defect in the quality of a medicinal product is generally considered to be a non-conformity of the medicinal product with the specification in the marketing authorization dossier, usually manifested as any unusual characteristic that does not correspond to the description of the medicinal product in the package leaflet or summary of product characteristics.
This may include:
- a change in the appearance of the packaging of the product – inconsistencies in the labeling of the medicinal product on the outer and inner packaging, (e.g. unusual labeling on the packaging, color or material of the packaging, size or shape, leaks in the packaging, inconsistencies in the labeling of the inner and outer packaging of the product, or. A defect of the medicinal product is also if any of the packaging does not contain batch number or SUKL code on the packaging),
- change in the appearance of the medicine itself (e.g. change in colour or shape of tablets, cloudiness or precipitated particles in the case of solutions, content of glass, metallic spicules or other unusual objects),
- absence of package leaflet (except for homeopathic preparations and preparations manufactured directly in the pharmacy), measuring cup, application aids, etc,
- an atypical characteristic that does not correspond to the package leaflet (e.g. does not dissolve, cannot be shaken, cannot be divided).
WHO IS REPORTING
In addition to marketing authorisation holders, other operators and health care providers – manufacturer, distributor, pharmacist, doctor, nurse, health care worker, etc. – are obliged to report quality defects or suspected quality defects to the SCMP, see the document bellow:
The patient can report a suspected defect in the medicine either by himself or through the pharmacy, preferably the one where he picked up or purchased the medicine.
HOW TO REPORT
There are several ways to report a suspected quality defect in a medicinal product, It is also possible to use Word forms, send an e-mail with a description of the quality defect.
There are several ways to report a suspected quality defect in a medicinal product:
1) Preferably by completing the electronic suspected quality defect reporting form (only in czech language):
The form will be sent to the Quality Defects Department, SÚKL and a PDF version will be sent to the email address you have provided.
- Sample of a completed electronic form for a patient (pdf, 88 kB)
2) Filling out the form in Word format:
- Quality Defect Report for SUKL (doc, 44 kB)
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 defects in the quality of medicines, 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
Marketing authorisation holders and other operators shall notify the CMA of a suspected quality defect or quality defect on the basis of the obligation referred to in Article 33(3)(i) and Article 23(1)(c) of the Medicinal Products Act.
Patients who discover a defect in the quality of a medicine can report it to SÚKL, either on their own or through a pharmacy, preferably the one where they picked up or purchased the medicine.
All reports, both patient reports and those from marketing authorisation holders or operators, are processed and thoroughly investigated by the Quality Defects Unit. If the investigation confirms a quality defect, corrective and preventive measures are subsequently taken to prevent the recurrence of similar quality defects. In this way, the basic mission of SÚKL is fulfilled, i.e. to ensure that only quality, safe and effective medicines are available on the market in the Czech Republic.