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Focus on Regulation

Tag Archives: medicinal products

Scientific progress enables EMA to improve guidance on medicinal products containing genetically modified cells

The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. The proposed revision will update the previous Guideline of 2012. EMA’s concept paper is intended to address the issue that the current guideline does

UK MHRA publishes “top tips” for manufacturing authorisation applicants

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce delays in processing applications. The MHRA is required to grant or refuse applications for manufacturing authorisations within 90 days of receiving a completed application. The

Notification of draft Commission Delegated Regulation on the Implementation of Obligatory Safety Features for Medicinal Products

On 12 August 2015, the European Commission notified the World Trade Organisation (“WTO”) of its draft Delegated Regulation supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the outer packaging of medicinal products for human use (hereafter “draft Commission Delegated Regulation”).

New UK Registration Requirements for Online Medicine Retailers

From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together

European Court rules that products can be classified as both medical devices and medicinal products in the EU

On 3 October 2013, the Court of Justice of the European Union issued a judgment in Case C-109/12[1], which concerned the implications of classification of a product as both a medical device and as a medicinal product within the same EU Member State and within the European Union (hereinafter “EU”) Internal Market.  The case responds

European Commission adopts the black symbol to be placed in the patient information leaflets for medicinal products subject to additional monitoring in the EU

On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in