Archives: Medicinal Products

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The German Supreme Administrative Court Confirms That E-Cigarettes Are Not Medicines Or Medical Devices

On 20 November 2014 the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) confirmed that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices.… Continue Reading

EU Court Of Justice Further Clarifies Definition Of Medicinal Products – And Raises New Questions

On 10 July 2014, the Court of Justice of the European Union (CJEU) gave its judgment in a case involving “legal highs” that a substance which only influences physiological functions without any beneficial effects on human health, shall not be considered as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC (decision … Continue Reading

European Commission Fines Servier and Five Generic Companies For Preventing Entry Of Generic Versions Of Blood Pressure Control Drug

On 9 July 2014, the European Commission’s Directorate General for Competition imposed fines totalling € 427.7 million on innovative pharmaceutical company Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin.  The Commission’s decision was the result of proceedings opened in 2009 and follows a Statement of Objections sent to the parties involved … Continue Reading

EMA clarifies interpretation of new variation categories in an amended Q&A document

On 6 February 2014, the EMA released an amended Q&A document on the implementation of the new Variations Guidelines of 2013, which provides details on the different variation categories and the operation of procedures laid down in Commission Regulation 1234/2008 concerning the examination of variations to the terms of marketing authorizations for human and veterinary … Continue Reading

EMA launches adaptive licensing pilot project

On 19 March 2014, the EMA announced the launch of its adaptive licensing pilot project along with an invitation to interested companies to submit their ongoing medicine development programmes to be considered as pilot cases. The term “adaptive licensing” (also known as “staggered approval” or “progressive licensing”) describes a process which allows patients to have … Continue Reading

Call for expression of interest to participate in early dialogue between HTA bodies and healthcare product developers

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices. The European Commission defines HTA … Continue Reading

EMA Releases Its First Product-Specific Guidance on the Demonstration of Bioequivalence for Public Consultation

On 15 November 2013, the EMA released the first draft product-specific guidance documents on the demonstration of bioequivalence for 16 active substances for public consultation. This first set of guidance builds upon the general principles set out in the Agency’s Guideline on the investigation of bioequivalence of 2010, which specified the requirements for the design, … Continue Reading

EMA Publishes Draft Guideline on the Use of Phthalates in Medicines

EMA has published a draft guideline on the use of phthalates as excipients in human medicinal products. The guideline establishes new Permitted Daily Exposure (“PDE”) values for the following phthalates that are among the most commonly used as excipients in medicinal products: dibutyl phthalate: 0.01 mg/kg/day diethyl phthalate: 4 mg/kg/day polyvinyl acetate phthalate: 2 mg/kg/day … Continue Reading

Advocate General Opinion on Reclassification of Medical Devices

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

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

This post originally appeared on our sister blog, InsideMedicalDevices. The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines.  The new guidance recognizes that medical devices — particularly software-based devices … Continue Reading

EU Financial Penalties for Centrally Approved Medicinal Products in Europe – How To Prepare?

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 … Continue Reading

What’s in a Name?

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

New Rules for Clinical Trials Proposed in Europe

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, … Continue Reading

Cost Considerations Should Not Drive Off-Label Drug Use in the EU

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 be somewhat in the shadows in … Continue Reading

Belgium – Regulatory Overview

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: „„ Medicines Law 1964. „„ Royal Decree of 14 December 2006 on … Continue Reading

Revision of the Rules on Pricing and Reimbursement of Medicines (The “Transparency Directive”) in the European Union

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 … Continue Reading

France – A ‘Sunshine Act’ for the Healthcare Industry

Originally published as Covington E-Alert on January 20, 2012 Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the “New Law”),creating Articles L. 1453-1 and L. 1454-3 to L. 1454-5 of … Continue Reading

Advertising of Medical Products and Summary of Product Characteristics (Smpc) before the European Court Of Justice

Originally published as Covington E-Alert on May 9, 2011 The EU Court of Justice just issued two long awaited rulings on the interpretation of the rules governing advertising of medicines in Europe. They address (i) the requirement that all advertising must comply with the prescribing information (SmPC) for the product and (ii) the distinction between … Continue Reading

Biosimilar Regulation: Important Considerations and Global Developments

Article originally published in the Life Sciences Handbook Cross-border in 2011  During the past ten years, many stakeholders have expressed an interest in the availability of biologically derived medicines authorised on the basis of previously authorised biological refer­ence products, that is, on the basis of a truncated dossier that includes a robust showing of similarity … Continue Reading

Nice Powers May Be Clipped In UK Pharmaceutical Pricing Overhaul

Originally published as Covington E-Alert on November 10, 2010 The UK government will consult in the coming year on proposals to move the UK’s National Health Service (NHS) towards a value-based system of pricing medicines from 2014. While official details are yet to be published, it is expected that doctors will be given powers to … Continue Reading

Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety

Article originally published in the Food and Drug Law Journal (with permission from FDLI), August 2008 I. INTRODUCTION Pharmacovigilance is a global public health activity that is currently undergoing a considerable amount of regulatory, social and political change. The standards expected by society have been raised following high-profile product withdrawals. Industry, regulatory authorities and consumers … Continue Reading

Medical Nanotechnology in Europe

 Article originally published in RAJ Pharma in July 2008 By 2015 nanotechnology-based medicines and medical devices are expected to flood the global market. Brian Kelly and Peter Bogaert discuss the regulatory and legal implications of medical nanotechnology in Europe. Nanotechnologies are the design, characterisation, production and application of structures, devices and systems by controlling shape and size … Continue Reading

European Commission’s Public Consultation on the EU Pharmacovigilance System

Article originally published in EURALex, issue 192, in March 2008 The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. Grant Castle and Robin Blaney … Continue Reading