Hogan Lovells (JD Supra Belgium)

The Belgian Data Protection Authority (DPA) has published brief guidance concerning the European Court of Justice (ECJ) judgement on the European Commission’s adequacy decision provided by the EU-US data Privacy Shield (Schrems II).

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.....

In the context of their return-to-work policies companies are seeking solutions to detect individuals with fever at the entrance of their premises with the aim of preventing further contamination within the buildings.

As of 1 June 2020, a new form of competition law infringement will be enforceable in Belgium*in addition to the prohibitions on anti-competitive agreements and abuses of a dominant position. The new Article IV.2/1 of the Belgian Competition Act (CA), applicable in the B2B context only, now prohibits companies from abusing a non-dominant position vis-à-vis companies that are "economically...

On 3 June 2020, the AFMPS issued the third version of the Agency’s alternative test protocol (ATP) for surgical face masks. The alternative test protocol was initially published on 14 April 2020, and allowed masks that had not undergone a conformity assessment procedure in accordance with applicable standards to be placed on the Belgian market.

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 previously extended until 1 June 2020.

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 to reprocess used medical devices.

The Belgian Federal Agency for Medicines and Health Products (AFMPS) has announced that it has abolished measures introducing quotas for the supply of paracetamol-based medicinal products.

On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with glucose-6-phosphate dehydrogenase (G6PD).

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.

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 Medicines and Health Products (AFMPS/FAGG) to remedy the shortage of protective and medical equipment in the context of the COVID-19 pandemic, has prepared a guidance on the...

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

The General Administrator of the AFMPS issued a Decision on 1 April 2020 introducing urgent measures regarding specific medicinal products used in the context of the SARS-CoV-2 pandemic.

The Belgian competent authority (FAGG/AFMPS) has banned the supply and use of rapid diagnostic self-tests for the coronavirus (COVID-19) for six months. The purpose of the ban is to avoid misinterpretations of negative results generated from use of the tests.

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.

On January 17, The Belgian Data Protection Authority (DPA) published Recommendation no 01/2020 providing Guidance on direct marketing. The Recommendation provides a methodology on how to comply with the General Data Protection Regulation (GDPR) when conducting direct marketing.

On 1 October 2019, the Belgian Competition Authority (BCA) adopted a new set of guidelines relating to exchanges of information in the context of trade associations. Following the lack of clarity highlighted by some market participants, the main objective of these guidelines is to provide legal certainty as to the type of information and market data that trade associations can exchange,...

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.

The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human medical applications or for scientific research purposes.

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.