Sarah Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. Ms. Cowlishaw also advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.
The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline). The Draft Guideline applies to fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The … Continue Reading
On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for cosmetic product safety reports. The … Continue Reading
On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12). The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU). However, in the majority … Continue Reading
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 … Continue Reading