The Falsified Medicines Directive has now been transposed into UK legislation and came into force on 20th August 2013. The new Directive introduces measures to prevent the entry of falsified medicines into the legal supply chain. Read more “Falsified Medicines Directive now in force in the UK”
Year: 2013
Electronic cigarettes and nicotine-containing products to be licensed medicinal products
Following the MHRA’s announcement at the end of July that the government will regulate electronic cigarettes and other nicotine containing products (NCPs) as medicines, the MHRA has issued further guidance to the industry. Read more “Electronic cigarettes and nicotine-containing products to be licensed medicinal products”
New Variation Guideline
The European Commission has published an updated Variations Guideline, to be implemented from 4th August 2013. The Guideline takes account of new PV legislation, technical progress, and the experience from using the current variation classifications. Read more “New Variation Guideline”
A new Head for Regulis
John Hart joined Regulis last week as Head of Pharmacovigilance and Medical Information and QPPV, replacing Alex Fernandez. Read more “A new Head for Regulis”
Regulis Article Published in Regulatory Rapporteur
Amy Whyte and Kim Wharton wrote an article for the May edition of Regulatory Rapporteur titled ‘A Guide to Legal Status Switches in Europe’.
MHRA Fees Increase
The MHRA have confirmed that after reviewing their fee structure, they are raising the fees for applications and all categories of variations by 2.8%. Read more “MHRA Fees Increase”
EC Publishes Update Guidelines for GDP
The European Commission has published revised guidelines on Good Distribution Practice in the European Union Read more “EC Publishes Update Guidelines for GDP”
Labels and leaflets
Following a consultation period, the MHRA have published guidelines regarding the changes to labels and leaflets. Read more “Labels and leaflets”
MHRA Innovation Office
The MHRA is launching an ‘Innovation Office’ to help organisations who are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies. Read more “MHRA Innovation Office”
New Black Symbol for products under Intensive Surveillance is announced
On the 7th March 2013 the EU Commission adopted an Implementation Regulation introducing a Black Symbol to identify medicinal products that are subject to additional monitoring. Read more “New Black Symbol for products under Intensive Surveillance is announced”