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Medical Devices › Pharmaceutical Industry › Belgium

Hogan Lovells

MDCG guidance for consultations of authorities on devices incorporating a medicinal product

Hogan Lovells on

On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more

Hogan Lovells

The AFMPS further extends measures to combat shortages of medicinal products by another month

Hogan Lovells on

On 29 May 2020, the AFMPS issued a new decision which further extends the measures initially provided in the Decision 1 April 2020 concerning supply of specific medicinal products by another month. These measures were...more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

AFMPS issues Circular allowing hospitals to reprocess single-use devices

Hogan Lovells on

In light of the challenges posed by the COVID-19 pandemic to the usual channels of manufacture and distribution of medical devices, healthcare institutions have begun to manufacture medical devices and their accessories and...more

Hogan Lovells

MDCG guidance on notified body audits in the context of COVID-19 restriction measures

Hogan Lovells on

As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices legislation has been significantly affected....more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

New Belgian legislation on the distribution of medical devices

Hogan Lovells on

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

Hogan Lovells

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

Hogan Lovells on

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....more

A&O Shearman

"Sunshine" in Belgium: New Statutory Transparency Requirements for Life Sciences Companies

A&O Shearman on

On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices...more

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