On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU. The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023. The Commission intends
Continue Reading EU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast
Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences
Continue Reading EU Pharma Legislation Review Series: New Classification Mechanism for Borderline Cases
The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”). In this blog, we provide an overview of the
Continue Reading EU Pharma Revision Series: Pharmacovigilance
On April 26, 2023, the European Commission proposed the long awaited reform of the EU’s pharmaceutical regulations (see here to view our previous blogs on the subject). This blog post discusses the data protection aspects of the proposals, which relate to the data processing activities of the European Medicines Agency
Continue Reading EU Pharma Legislation Review Series: Data Protection Aspects
The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the
Continue Reading EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.
Disclosure of documents in response to an
Continue Reading EU Pharma Legislation Review Series: Access to Documents and Transparency of R&D Funding
The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new
Continue Reading EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
The existing EU pharmaceutical legislation provides for a number of specific exemptions from the marketing authorisation requirement, including products supplied on a named patient or compassionate use bases; products compounded and dispensed in pharmacies (magistral and officinal formulations) and also for products necessary to respond to public health emergencies. Given
Continue Reading EU Pharma Legislation Review Series: Pharmacy and Hospital Exemptions
As part of its policy goal of promoting innovation, the Commission’s proposed Regulation creates the concept of a “regulatory sandbox.” If the concept survives the legislative process, the sandbox will be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a
Continue Reading EU Pharma Legislation Review Series: The Regulatory Sandbox – A Safe Space for Innovators to Grow
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation. As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules. Not least the incorporation of the EU’s amended paediatric and orphan
Continue Reading EU Pharma Legislation Review Series: Paediatric Medicines