Medicines Authority review of COVID self-test brands for sale at pharmacies expected ‘within hours’

The first results from Malta Medicine Authority (MMA)’s assessment of COVID self-tests are expected to be published in the coming hours, authority Chairman Anthony Serracino Inglott has told BusinessNow.mt.

Speaking on Thursday after a report in Times of Malta stated that pharmacists had been ordered to stop selling COVID self-test kits pending MMA authorisation of the individual types, Prof Serracino Inglott stated that assessment on the kits is currently already underway.

These assessments could demand the collection of additional information, but the Chairman stated that at least preliminary results will be released on the authority’s website “in a few hours.”

Earlier in April, Health Minister Chris Fearne announced that self-testing for COVID would be permitted from this, in line with the Government’s emphasis of self-regulation and responsibility for the virus. 

Self-testing, via rapid antigen tests, has long been permitted for use in many European countries, but has officially been banned for use in Malta since the start of the pandemic, although tests have been available unofficially.

The Legal Notice permitting these tests was published on Monday and specified that “any person who wishes to place a COVID-19 Test Kit on the Maltese market shall submit an application to the [MMA] for approval.”

It also stated that the list of approved COVID-19 Test Kits shall be published in the Government Gazette by the Superintendent of Public Health, and that the list will be made available on the Government’s official COVID-19 website.

The stakes are high for pharmacies preempting approval, as restrictions of Medical Devices and In-Vitro diagnostic Medical Devices, introduced in 2020, warned that any person dispensing unlicensed or approved diagnostic devices could be liable to face a fine of between €12,000 and €120,000 or a two year jail term.