To ensure people have access to medicines and medical devices during the Coronavirus (COVID-19) pandemic, extraordinary measures have been introduced that apply to those involved in the circulation of medicines.
For this purpose, instruments have been created to establish additional stocks of medicines and medical devices in healthcare units of the Portuguese national health service (“SNS”). In addition, measures have also been adopted to manage and monitor the availability of medicines and other healthcare products.
In parallel with this, the obligations on market authorisation (AIM) holders and wholesalers relating to the prevention and notification of shortages in stocks or medicines, or in stocks running out completely, take on particular importance in the current situation.
This note is intended to provide an overview of the general implications of the Coronavirus pandemic on the management of medicines and medical devices.
PLMJ has created a multidisciplinary team dedicated to analysing the legal and operational challenges that businesses are facing. Our team’s mission is work hand-in-hand with our clients to find the best solutions to mitigate the risks and to relieve some of the pressure they are under.
We have created a Coronavirus Hub to share practical information to help mitigate the risks for companies in Portugal.
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