In an earlier blog, we had reported on an interesting litigation case concerning the legal scope of the market exclusivity right for orphan drugs in the EU. Meanwhile, there have been further developments in this court case and its key questions have now been referred to the European Court of Justice (“ECJ”) for a
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The EPR Obligations of the New Urban Wastewater Treatment Directive: Key Questions and Next Steps for Member States
The European Union has just published a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) in the EU’s official journal. The UWWTD imposes important new Extended Producer Responsibility (“EPR”) obligations that will have a significant financial and administrative impact on companies marketing human medicines and cosmetic products in the EU. Member States must implement
MHRA Consults on New UK Pre-Market Medical Device Measures
Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).
On 14 November 2024, the MHRA
EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025
The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications, or where the
EU Court Overturns EU-wide Botanical Food Ban
In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods. The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.” Moreover,
UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?
On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here). Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical
EU Talking Life Sciences Audiocast: Regulatory and Policy Developments from South Africa – SAHPRA’s Proposed Black Economic Empowerment (BEE) Policy
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Deon Govender discuss Regulatory and policy developments from South Africa: SAHPRA’s proposed Black Economic Empowerment (BEE) policy and its potential impact on license holders for medicines and medical devices
EU Talking Life Sciences Audiocast: Developments in the African Medicines Agency and Regulatory Convergence
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Grant Castle discuss developments in the African Medicines Agency and regulatory convergence.
EU Talking Life Sciences Audiocast: WHO Prequalification Procedures in Africa
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize discusses WHO prequalification procedures in Africa.
New ABPI Code and PMCPA Constitution and Procedure Published
Those of us who advise on medicines advertising issues have been waiting for much of 2024 for the Association of the British Pharmaceutical Industry (“ABPI”) together with its self-regulatory body for pharmaceutical advertising, the Prescription Medicines Code of Practice Authority (“PMCPA”), to publish the new Code of Practice for the Pharmaceutical Industry (“ABPI Code”). On