News on retailing COVID-19 testing in Romania – ANMDMR opinion on the sale of rapid tests

On 13 November, the National Agency for Medicines and Medical Devices in Romania (ANMDMR) published on its website an announcement regarding the sale of rapid tests for the diagnose of COVID-19. The announcement targets antigen detection tests, but also antibodies tests used to assess the immunological status of patients, by determining the presence of IgM / IgG antibodies against SARS-CoV-2.

The good news is that the announcement is a first official opinion in Romania which clarifies the retail regime of such tests. Also, the announcement provides guidance on who should perform the tests, conditions to place on the market and how to be sold to the general public.

COVID-19 testing is for professional use only

The antigen test is the newest type of test, currently the only rapid test that detects SARS-CoV-2 infection. ANMDMR indicates that this test is for professional use, which means that it is recommended that the sampling and interpretation of results to be performed by qualified medical personnel. This is in line with the recently published recommendation of the European Commission on antigen tests, stating that trained healthcare and laboratory staff are needed to carry out sampling, testing, test analysis and reporting of test results to clinical staff and public health authorities.

ANMDMR also mentions that the test is not for self-testing. Rapid self-testing tests have a different marketing regime, with the involvement of a notified body that assesses the conformity of these products. Also, medical devices must be such way designed and constructed that, under the conditions and for the intended purpose, they do not directly or indirectly compromise the clinical condition or safety of patients, the safety and health of those who use them or other persons or property security. As long as the rapid tests are not used by professionals, as stated in the manufacturer's instructions for use, the results may be compromised.

Conditions for placing on the market

Government Decision no. 798/2003 on the establishment of the conditions for placing on the market and use of in vitro diagnostic medical devices establishes that in the case of these tests, in order to apply the CE marking, the manufacturer must follow the procedure mentioned in Annex no. 3 and issue the EC declaration of conformity before placing the devices on the market. Therefore, products are placed on the market on the basis of the declaration of conformity given by the manufacturer.

As mentioned by ANMDMR, the distribution of medical devices for in vitro diagnosis for professional use can be done to:

- Other economic operators in the distribution chain, who have an operating permit for the distribution of medical devices, in order to resell or donate the products;

- End-users (health facilities, offices, clinics, etc., carrying out testing activity).

Sale of COVID-19 tests: online retail or pharmacy retail?

According to art. 2 of the Pharmacy Law no. 266/2008, only medical devices for individual use can be distributed through community pharmacies. As a result, in vitro diagnostic medical devices for professional use cannot be distributed via pharmacies channel.

As regards the online channel, ANMDMR states that at this moment, there are no legal provisions prohibiting this practice. As a competent authority, as there are no regulations in this regard, ANMDMR cannot prohibit the marketing of these products online.

ANMDMR generally suggests avoiding this method of sale and if such distribution is pursued, it recommends that (i) the sale of rapid tests to be accompanied by a warning in accordance with the instructions for use, namely “for professional use only” or that (ii) the online retailer ensures that the entity purchasing the products is a medical unit. Otherwise, the economic operator may be sanctioned for misleading commercial practice. Without any restrictions in terms of delivery, this might open new opportunities also for delivery of home-kit COVID-19-testing for on-demand deliveries from compliant retailers.

In other EU countries, for instance in Germany, rapid tests are not freely available, while in France, such tests can be administered in pharmacies by pharmacists. Similarly, in the UK pharmacy retail COVID-19 tests are available.