1. New pharmaceutical legislation
With the so-called Pharmaceutical Strategy, the EU Commission in parts fundamentally amends the legislation on pharmaceuticals for use in humans.
Drafts have been leaked during the past few weeks, though the EU Commission plans to present its proposals mid-March.
Whilst there a no official documents pertaining to the new EU Directive and Regulation in the context of the EU Commission’s Pharmaceutical Strategy, there has already been much ado about the leaked documents.
The placing of medicinal products on the market is subject to a harmonised regime through Directive 2001/83/EC and Regulation 726/2004, the cornerstones of EU pharmaceutical law.
Directive 2001/83/EC contains the basic principles and rules generally applicable to all medicinal products, from the key requirement to hold a prior marketing authorisation to manufacturing, safety and trade control, distribution, distant sales, labelling, pharmacovigilance and advertising.
Regulation 726/2004 sets up the centralised authorisation procedure and the European Medicines Agency (EMA).
Under the Pharmaceutical Strategy, which has been discussed on this Blog before, adopted on 25 November 2020, the Commission aims at a future proof regulatory framework, addressing some of the challenges the industry faces and allegedly promoting research and technologies.
Cornerstones are legislative measures, i.e. the Directive and Regulation currently under discussion and non-legislative action, in particular
- ensuring access to affordable medicines
- supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry
- enhancing crisis preparedness and addressing medicines shortages
- promoting a high level of quality, efficacy and safety standards
We will report on the official proposals.
2. Extensions regarding transitional periods pertaining to Medical Device Regulation and In-Vitro Diagnostics Regulation
The Council of the European Union yesterday, March 7, 2023, voted in favor of the European Commission’s proposal to amend the transitional provisions for certain medical devices under the MDR/IVDR. Whilst the amendment will not introduce substantive revisions to the quality, safety, and performance provisions set forth in the MDR and the IVDR, it will give medical device manufacturers additional time to bring their devices into conformity with the requirements in those Regulations.
What does this mean?
There will be
- an extension of the transitional periods foreseen in the MDR for certain devices certified in accordance with the Medical Devices Directive 93/42/EEC (“MDD”) and the Active Implantable Devices Directive 90/385/EEC (“AIMDD”) on the basis of the risk classification;
- a prolongation of the validity of CE certificates of conformity issued in accordance with the MDD, AIMDD and the In Vitro Medical Devices Directive 98/79/EEC (“IVDD”) prior to 26 May 2021; and
- the permission to sell medical devices and IVDs certified in accordance with the MDD, AIMDD and IVDD which are on the market, to continue to be sold beyond the original deadline.