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Els Janssens

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In EU Pharmaceutical Package

EU Pharma Package: How Significant are the Proposals for Orphan Medicines?

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On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue our analysis of the Proposals with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines. 2. The orphan designation criteria remain largely unchanged, meaning…

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In EU Pharmaceutical Package

A New Dawn for the EU Pharma Regulatory Regime? The Commission’s Proposal to Revise the EU Pharmaceutical Legislation is Finally Published

by , and 5 Mins Read

Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…

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In Medical Devices

EU MDR Amendment Enters Into Force: What Does This Mean for your Legacy Devices?

by , , and 3 Mins Read

In brief The amendment to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Medical Device Regulation 2017/746 (IVDR) has been published and enters into force immediately (20 March 2023). What does this mean for your organisation? The amendment extends transitional periods under the MDR for legacy devices (if manufacturers act now) and removes the “sell-off” date under the MDR and IVDR. We’ve set out our top four takeaways below: 1. New extended transitional…

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In Medical Devices

Waiting for your EU MDR Certificates? 5 Takeaways on the Intended Extension to Transitional Periods

by , , and 9 Mins Read

In brief In a recent EPSCO meeting, the European Commission (“Commission”) finally confirmed that it intends to extend the transitional period under the Medical Devices Regulation 2017/745 (MDR). In parallel, the Medical Device Coordination Group (MDCG) has published a Position Paper (2022-18) that offers a supplemental or short-term solution, allowing manufacturers to benefit from an exemption under Article 97 for a temporary period. While this means that the outlook for MDR implementation is more positive, the Commission’s approach is…

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In Pharmaceuticals & Biotech

Proposal for a New EU Product Liability Directive Published

by and 1 Min Read

Impact on medicines and medical devices In brief Medicines and medical devices are subject to the EU’s general product liability rules, including the EU’s Product Liability Directive (PLD). The European Commission’s proposal for a new PLD seeks to make the PLD fit for purpose in the 21st century and address challenges faced by those who have suffered damage to claim compensation. In doing so, the Commission has expanded the scope of the PLD so that…

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In Pharmaceuticals & Biotech

European Court of Justice Advocate General supports a Literal Interpretation of the Global Marketing Authorization Concept

by and 6 Mins Read

In brief On 6 October 2022, Advocate General Medina issued an Opinion in three joined appeal cases brought by the European Commission, the EMA and Biogen against Pharmaceutical Works Polpharma. The opinion touches on the concept of global marketing authorization (GMA), and on the principle of mutual recognition of scientific assessments carried out by Member States authorities and EU institutions. In depth This is the first case related to the question of whether an authorized fixed combination…

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