Marketing authorization holders have three years from 17 May 2023 to remove any “negative formulations” from their existing and future medicines packaging.
On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation. The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorization and supervision of medicines.
On 26 April 2023, the European Commission 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 Strategy for Europe, and its aim is to make medicines more available, accessible and affordable whilst at the same time supporting innovation and boosting the competitiveness of the EU pharmaceutical industry.
In a recent EPSCO meeting, the European Commission finally confirmed that it intends to extend the transitional period under the Medical Devices Regulation 2017/745. In parallel, the Medical Device Coordination Group has published a Position Paper (2022-18) which offers a supplemental or short-term solution, allowing manufacturers to benefit from an exemption under Article 97 for a temporary period.
On 19 September 2022, the Commission unveiled its proposal for a Regulation for the New Single Market Emergency Instrument (SMEI) to secure crucial supply chains in future emergency situations. The Commission describes the SMEI as a crisis governance framework to ensure the free movement of goods, services and persons and the availability of critical goods and services within the EU during emergencies. The SMEI is not specific to health but applies to all kinds of crises having an impact on the functioning of the single market and its supply chains. ‘Crisis’ is quite vaguely defined as an exceptional unexpected and sudden, natural or man-made event of extraordinary nature and scale that takes place inside or outside of the Union.
In September 2022, the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group (MDCG), issued a manual to determine whether a particular product qualifies as a medical device or in vitro diagnostic and into which class a particular medical device or in vitro diagnostic falls. The MDCG is operating under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation.
A revision of EU pharmaceutical legislation by the European Commission will be published on 21 December. These revisions indicate the execution of the European Commission’s 2020 Pharmaceutical Strategy – a strategy that seeks to create a more resilient regulatory system in light of the COVID-19 pandemic.
The European Recovery Plan will pump EUR 750 billion into the economy in the relative short term, with nearly half earmarked for climate change and digital investment. This funding will support the transformation to greener, more digital, sustainable and resilient economies, and businesses active across the EU will be able to benefit.
Manufacturers and EU importers of medical devices are periodically confronted with new sets of rules imposing new product conformity requirements. Apart from MDR/IVDR, other EU legislation as well as revisions of ISO standards may compel companies to secure future marketability of legacy products on stock before the expiry of transition periods. To take advantage of transition mechanisms, EU legislators regularly require that affected products have to be “placed on the market” prior to a cut-off date. But what does that mean, and how should companies practically implement and record a “placing on the market”?
Explore Data PULSE, a platform which helps you to navigate the complex landscape of data, regulatory and IP protection concerns at each stage of the medical product life cycle. As you navigate through each key issue, Data PULSE will help you to identify and mitigate risks across multiple jurisdictions and optimize your strategy through research, market authorization and post-market study phases.