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Developments in Spain on promotion of authorized medicinal products pending pricing & reimbursement

The debate in Spain on the possibility of promoting medicinal products in the period between marketing authorization and pricing & reimbursement has recently taken on a special...


Draft text of new Spanish regulation on medical devices is opened for contributions

The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10...


Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment...


Use of face masks in Spain becomes mandatory

As of 21 May 2020, the use of face masks (preferably, hygienic and surgical) by the general population in Spain (six years onwards, unless an exclusion applies – see below) becomes...


Spain takes new steps to facilitate the availability of a wide range of PPE

It looks like Spain has taken definitive steps to face the current situation of shortage of Personal Protective Equipment (PPE), not only for face masks, but also for a wider...


Spain intervenes in the price of face masks and other essential products within the COVID-19 context

According to the new Order SND/354/2020 of 19 April issued by the Spanish Ministry of Health, the pricing authority has 48 hours to set the maximum retail price of surgical masks, nitrile...


Spain issues order to facilitate access to personal protective equipment

The Spanish Ministry of Health has implemented new measures to facilitate the manufacture and marketing of face masks and white coats classified as medical devices for the duration of...


Spain responds to COVID-19 with new reporting obligations, supply chain controls

The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing...


Impact of Spanish government's COVID-19 measures on life sciences companies operating in Spain
Registered Content

With more than 17,000 people currently infected in Spain, the national government has granted the Ministry of Health far-reaching powers to contain the coronavirus, and has issued several...

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