Hélène Boland

Hélène Boland

Hogan Lovells

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COVID-19- AFMPS reviews its export ban on certain medicinal products outside the EEA

The Belgian federal agency for medicines and health products (AFMPS or FAGG) provides that Belgium acts as a logistical platform for certain medicinal products....more

4/9/2020  /  Belgium , Coronavirus/COVID-19 , EU , European Commission , European Economic Area (EEA) , Export Controls , Exports , Goods or Services , Medical Supplies , Supply Chain

Belgium follows the FDA's approach on the reprocessing of surgical masks and FFP2/FFP3 facemasks

Given the challenges in maintaining the supplies of healthcare materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by the Belgian Federal Agency for...more

4/9/2020  /  Belgium , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Personal Protective Equipment , Pharmaceutical Industry , Public Health , Relief Measures , Supply Chain

Belgian AFMPS latest guidance in the context of COVID-19 outbreak

The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. ...more

3/20/2020  /  Belgium , Clinical Trials , Coronavirus/COVID-19 , Emergency Management Plans , Personal Protective Equipment , Pharmaceutical Distribution , Public Health

New Belgian legislation on the distribution of medical devices

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

1/28/2019  /  Belgium , EU , EU Directive , Life Sciences , Medical Devices , New Legislation , Pharmaceutical Distribution , Pharmaceutical Industry , Regulatory Oversight , Regulatory Standards
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