Originally published as Covington E-Alert on September 26, 2012
Today the European Commission published its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro
Continue Reading New Medical Devices Regulations in the EU – Significant Changes But No Big Bang
Originally published as Covington E-Alert on September 17, 2012
Commission Regulation No. 658/20071 (the “Penalties Regulation”), as recently amended by Commission Regulation No. 488/2012,2 empowers the European Commission to impose financial penalties in relation to medicinal products approved through the centralised procedure. No financial penalties have yet been imposed, but
Continue Reading EU Financial Penalties for Centrally Approved Medicinal Products in Europe – How To Prepare?
Article originally published in European Pharmaceutical Contractor, September 2012
Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour
The European Commission
Continue Reading What’s in a Name?
Originally published as Covington E-Alert on August 1st, 2012
On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated
Continue Reading New Rules for Clinical Trials Proposed in Europe
Article originally published in Scrip Regulatory Affairs, June 2012
With off-label drug use in the EU moving into the regulatory spotlight, it is becoming clear just how limited member states are in their power to stimulate – or indeed allow – the practice.
Off-label use of medicines always used to
Continue Reading Cost Considerations Should Not Drive Off-Label Drug Use in the EU
Originally published as Covington E-Alert on May 17, 2012
On 15 May 2012, the Advocate General of the EU Court of Justice issued his opinion on the appeal of the General Court’s judgment in AstraZeneca v. Commission.1 The Advocate General largely agreed with the reasoning and holdings of the General
Continue Reading The Advocate General’s Opinion in Astrazeneca v. Commission
Originally published as Covinton E-Alert on May 25, 2012
On 16 May 2012, the European Commission adopted the much delayed list of permitted general health claims (Permitted List) for foods after scrutiny of the list by the European Parliament and the Council ended on 27 April 2012. The Permitted List
Continue Reading European Commission Adopts List of General Health Claims
Article originally published in the Life Sciences Handbook, 2012
1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?
Legislation
The main legislative acts regulating medicinal products are the:
Originally published as Covington E-Alert on March 1st, 2012
Today the European Commission published its long awaited proposal for the revision of the so-called Transparency Directive. The Directive lays down procedural guarantees for the systems that regulate the pricing and reimbursement (“P&R”) of medicines in the thirty EU and EEA
Continue Reading Revision of the Rules on Pricing and Reimbursement of Medicines (The “Transparency Directive”) in the European Union
Article originally published in EuroWatch on August 15, 2011
The Council of the European Union has adopted a position at First Reading on a proposal for a Regulation on Biocidal Products that would impose new requirements on goods treated with biocidal products (“Council First Reading”).1 The new rules would apply to a wide variety of consumer goods, such as furniture and other wood products, packaging, electronic equipment, plastic materials, paper and tissue products, absorbent hygiene products, apparel, paints, and kitchen accessories, and are likely to have a significant impact on goods imported into the European Union or European Economic Area.
The Council First Reading would significantly change the EU regulatory framework for materials (i.e., articles, mixtures, and substances) treated with or incorporating biocidal products. On the one hand, the new rules would limit the scope of the strict requirements that apply to biocidal products to only those materials that have a primary biocidal purpose. On the other hand, however, they would also create a new category of rules for all materials that intentionally incorporate or have been treated with biocidal products (so-called “treated articles”) even if such materials do not have a primary biocidal purpose.
Continue Reading Upcoming EU Requirements on Goods Treated with Biocidal Substances