TMQA Latest News

Launch of Yellow Card Smartphone App

The Yellow Card Scheme was launched in 1964 following the Thalidomide disaster to monitor the safety of UK medicines and act as an early warning system to identify potential side-effects and adverse reactions. The scheme is run by the MHRA who collate and review reports of suspected adverse drug reactions on all licensed and unlicensed medicines and vaccines.  Yellow Cards are used, alongside other scientific safety information to help the MHRA make changes, if necessary, to the warnings given to people taking a medicine or vaccine, or to the way they are used, to minimise potential risks. A new Yellow Card smartphone app has been launched this month for people to report problems with medicines. It provides a convenient alternative to using paper Yellow Card forms or the Yellow Card website. It is the only app that allows patients, carers and healthcare professionals to report side effects directly to the Yellow Card Scheme. Users can select specific medicines or vaccines to track and receive news and alerts about them. The app has been created in collaboration with the Innovative Medicines Initiative WEB-RADR project – a large-scale, public-private partnership between the European Commission, national regulatory authorities, academia, small and medium-sized enterprises and the European Federation of Pharmaceutical Industry Associations (EFPIA) that aims to boost biopharmaceutical innovation. The app is free to use for anyone on iOS and Android. http://tinyurl.com/pgo4yfc 

 


Mandatory Use of Common Repository for Human Centralised Procedures

As of 10 July 2015, companies are required to submit their centralised procedure applications for human medicines to the EMA via eSubmission Gateway/Web Client only, rather than to individual Member States on CDs/DVDs or via the Common European Submission Platform (CESP). The applications submitted via the eSubmission Gateway/Web Client will be made available to all national competent authorities via a common online repository. The common repository has been available since Feb 2014 and enables national competent authorities to safely search, browse and download centralised procedure electronic common technical document (CTD) submissions for human medicines. The system is expected to accelerate the validation of incoming applications and will ensure continuous and immediate access to up-to-date dossiers by all national competent authorities.  http://tinyurl.com/prbgh4t


Mandatory EU Common Logo for Selling Drugs Online

From 1 July 2015 anyone in the UK selling medicines online to the general public in the UK or another European Economic Area (EEA) country needs to be registered with the MHRA and be included in the MHRA’s list of UK registered online retail sellers. In addition, the new EU common logo must be displayed on all pages of the website offering the medicine(s) and contact details of the MHRA and a link to the MHRA’s website must be included. The registered EU common logo will contain a hyperlink to the company’s entry in the MHRA’s list of registered online sellers. Anybody buying medicines online can check if the website is legitimately registered and will be able to click on the logo which will take them through to a list of registered sellers. The European Commission has generated technical guidance on using the logo, which can be found at: http://tinyurl.com/nftn65s

Falsified medicines are a major threat to public health and safety and hence the aim of the new EU common logo is to help members of the public to identify websites that can legally sell medicines. The penalty for selling medicines online without being registered and not displaying the logo is up to 2 years in prison or a fine or both. http://tinyurl.com/plm56sj


Electronic Application Forms become Mandatory for all Centralised Marketing Application Authorisations

As of 01 July 2015, the use of electronic application forms provided by the EMA for all centralised marketing authorisation applications for human and veterinary medicines became mandatory. Forms can be downloaded from the electronic Application Forms (eAF) website: http://esubmission.ema.europa.eu/eaf/index.html. The electronic application forms reflect and capture the same content as the previous paper-based versions. Their use is expected to reduce the administrative burden for both the regulatory authorities and pharmaceutical companies. The electronic forms were initially released in 2012 and have been significantly improved since that time following feedback received. From January 2016, the use of electronic application forms will also be mandatory for all other EU marketing authorisation procedures for human and veterinary medicines, i.e. the decentralised procedure (DCP), mutual recognition procedure (MRP) and for national submissions. http://tinyurl.com/oz8xxmp


MHRA Updates Phase I Accreditation List

The MHRA updated their list of accredited phase I units in June 2015. The updated list can be found at: http://tinyurl.com/o7ayg34

The MHRA’s phase I accreditation scheme is a voluntary scheme for organisations conducting phase I clinical trials, in particular for those conducting first in human (FIH) trials. Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards for avoiding harm to trial subjects and for handling any medical emergencies.