EU Legislation

Subscribe to EU Legislation

This post originally appeared on our sister blog, InsideTechMedia.  

After more than 40 years of discussions, the European Parliament today voted in favour of the “EU patent package,” hot on the heels of the European Council’s approval yesterday.  The EU patent package will create a Unitary EU Patent i.e. a uniform patent which will have equal effect and will be granted, transferred and enforced in a unitary way in most of Europe.  Unitary EU Patents will be granted through the existing European Patent Office, but a new court system will be set up to enforce these patents.

The Unitary EU Patent will, in time, replace the current system of European Patents which – after grant – operate as independent national patents in up to 38 countries.
Continue Reading A Unitary Patent for Europe is Finally Approved

This post originally appeared on our sister blog, InsideMedicalDevices.

The publication by the European Commission of two proposals for the revision of the EU regulatory framework for medical devices in September has initiated the legislative process which will ultimately lead to the adoption of the final EU Regulations on medical devices.  The proposals have been transmitted to the European Parliament and Council for their consideration.

At the European Parliament, the proposals have been assigned to the ENVI parliamentary Committee, responsible for environmental and public health matters.  Two German Members of the European Parliament have been appointed as “rapporteurs”, i.e., leaders of the parliamentary process: Mrs. Dagmar ROTH-BEHRENDT from the Socialists and Democrats’ group for the Regulation on medical devices and Mr. Peter LIESE from the Christian-democrats for the Regulation on IVDs.  Once adopted within the ENVI Committee, the reports will be sent to the consideration of the entire European Parliament, which will adopt its position on the legislation.  While the parliamentary work should begin early next year, the European Parliament’s plenary vote is currently expected for September 2013.
Continue Reading New Regulations for Medical Devices in Europe: Overview of the Legislative Process

This post originally appeared on our sister blog, InsideMedicalDevices.

On September 26, 2012 the European Commission adopted 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…

Originally published as Covington E-Alert on October 23, 2012

On October 17, 2012, the European Commission presented a proposal that would limit the consumption of food crop biofuels and bioliquids in Europe.1 The proposal is intended to respond to allegations that food crop biofuels and bioliquids result in higher world food prices and indirect land…

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 the situation may change following…

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 is expected to publish proposals…

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 by the pharmaceutical industry, academia,…

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 contains just 222 health claims…

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 Member States. The revision aims…

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