"In vitro" diagnostic healthcare products are regulated by Royal Decree 1662 / 2000. This Royal Decree provides, in General, the demand for prescription for sale to the public of the products of self-diagnosis, with the exception of pregnancy, fertility and blood sugar tests. On the other hand, subject to prescription healthcare products may not be advertising to the public.
In Spain, a large number of people who have HIV infection is unknown they are infected. Late diagnosis of infection is one of the main obstacles of the response to this epidemic, since it increases the morbidity and mortality associated, decreases the response to treatment and increases the transmission rate and the cost of health care. Within the objectives of the Strategic Plan for the prevention and Control of HIV and other STI 2013-2016, the promotion of the early diagnosis of HIV is to reduce the proportion of undiagnosed people. To do this, it is necessary to improve access to testing and implementation, which includes the use of products of self-diagnosis.
In order to facilitate access to HIV self-diagnostic test, has been modified by regulation the Royal Decree 1083 / 2017, of 29 December, which eliminates the requirement of limitation in his dispensing. Also, to promote the knowledge of the existence of this test, allowed the realization of advertising aimed at the public.
Video: Test of diagnostics of HIV in pharmacies - what you should know
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