As a result of its informal complaint procedure, the Hungarian Competition Authority (GVH) became aware that the website tesztkoronavirus.hu probably gave consumers the impression that the product of the COVID-19 (SARS-Cov-2) IgG / IgM antibody test kit is legally marketed. Although the website has not been available since the beginning of July 2020, the GVH advises consumers of the following.
If a rapid test according to its packaging or instructions for use is intended for self-testing, i.e. for home use, then its producer in accordance with the applicable legislation must first obtain certification from the competent authorising body before placing it on the market. Given that the minimum duration of this procedure is 6 months, it is likely that there are no coronavirus rapid tests intended for self-testing on the market in Hungary that would have received such a certificate. In the case of certified products, in addition to the CE marking, the four-digit number used to identify the certification body must also be provided.
Furthermore, such medical devices may exclusively be marketed in specialist shops operating with the provider’s authorisation or in pharmacies; they cannot be marketed in other stores or on web stores.
It must be clear from the packaging of the tests for professional use, the instructions for use and the description promoting the product that the product is intended for professional users. Therefore, it is also illegal for a trader to advertise a professional test for lay end users for home use.
The website also provided questionable information about the reliability of the product (e.g. “99.6% reliability”).
The GVH recommends that before purchasing a similar product online, consumers should make sure that the website is reliable:
- check the website for information about its operator (to ascertain whether the undertaking is real);
- it might be suspicious if there is no documentation on the site about the product or a document bearing a quality mark e.g. the CE marking is displayed, but the document is not legible, or the producer's/representative's data cannot be identified;
- read the GTC: it is a cause for concern if no such document is found on the page;
- store correspondence with the undertaking, take screenshots of the process;
- check the consumer opinions related to the site, be informed;
- in the case of promotions offering a significant discount, keep in mind that a product can only be advertised in this manner if the indicated original price was actually applied in the past, which is unlikely to be the case for tests that are just emerging on the market;
- review the terms of delivery, the cost of delivery, the laws must also apply to home deliveries, such as the right of withdrawal for 14 days.
Further information on the distribution and advertising of the products is available (only in Hungarian) on the website of the National Institute of Pharmacy and Nutrition: HERE
Budapest, 22 July 2020
Hungarian Competition Authority
Phone: (+36-30) 180-2060