Archives: Food & Drug Regulatory

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Comprehensive Amendments of German Drug Laws upcoming

Recently, the German Federal Ministry of Health published a new draft law (“Viertes AMG-Änderungsgesetz”) which aims to amend several provisions of the German Drug Act (Arzneimittelgesetz) and other drug-related laws. Most of the intended amendments result from an adjustment of German laws to the new European Clinical Trials Regulation (Regulation (EU) No. 536/2014). For instance, … Continue Reading

EU Agreement on a General Approach on the Medical Devices Package

This article was originally posted on our sister blog Inside Medical Devices On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the … Continue Reading

General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case

Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post. On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation … Continue Reading

IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition

This post was originally published on our sister blog Inside Medical Devices. On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here).  The General Approach does … Continue Reading

Italian Medicines Agency Publishes Public Assessment Reports of Medicines Authorised Through the National Procedure

The Italian Medicines Agency (AIFA) has announced that, as of 22 July 2015, it makes available on its website the Public Assessment Reports (PARs) of medicinal products authorised in Italy through the national procedure. For the medicines authorised from 2015 onwards, AIFA will publish the full PARs together with a summary understandable to a lay … Continue Reading

Mandatory registration and logo for UK online sales of medicines

By Colin Warriner Since 1 July 2015, anyone in the UK selling medicines online to the general public must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), and be on the MHRA’s list of UK registered online retail sellers.  In addition, those retailers now need to display, on every relevant page of … Continue Reading

MHRA grants second scientific opinion as part of the Early Access to Medicines Scheme

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS).  EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need. … Continue Reading

General Court Confirms Market Exclusivity Rights in CTRS Case

On 11 June 2015, the General Court handed down its judgment in Case T-452/14 Laboratoires CTRS v European Commission (the “CTRS Case”) annulling the Commission’s decision to grant Kolbam a marketing authorisation.  The General Court held that references in Kolbam’s SmPC to the efficacy of Kolbam for indications that Orphacol was authorised circumvented Orphacol’s market … Continue Reading

New Draft EMA-Guideline On Clinical Development Of Fixed Combination Medicines

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

European Court to Clarify Responsibilities and Liability for Medical Devices

A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence. Liability Spotlight now on the Notified Bodies Background and Context The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to … Continue Reading

EFSA Grants Public Access to Data through Scientific “Data Warehouse”

The European Food Safety Authority (EFSA) is launching an ambitious project of public access to data that it collects and holds through the launch of a scientific “data warehouse.” EFSA announced this initiative on March 2, 2015, with the aim to create an “open science organisation” and increase public access to data that it holds. … Continue Reading

EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation

On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the … Continue Reading

New French Rules On Off-Label Use

France has enacted new rules on the off-label use of medicines.  A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”).  This Decree follows the adoption of the amended social security budget bill … Continue Reading

Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection … Continue Reading

UK Data Protection Regulator Surveys Use Of Smart Medical Devices

 This post originally appeared on our sister blog, InsideMedicalDevices. The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps. The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for … Continue Reading

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

MHRA Creates New Expert Advisory Group on Medical Devices

This post was originally published on our sister blog Inside Medical Devices. On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015. The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices.  … Continue Reading

Commission Updates EU Medical Devices Borderline Manual

The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.  The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software.  The manual also provides new … 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

Update on the French Sunshine Rules

In August last year, we wrote about the extent to which the French “sunshine rules” apply to the medical devices industry (see our post), alongside the pharmaceutical and cosmetic industry, and other health-related industries. A number of developments have occurred since then. First, we highlighted in our previous post the uncertainty regarding the territorial scope … Continue Reading
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