In 2011, the European Commission (EC) published Directive 2011/62/EC, the Falsified Medicines Directive (FMD). The main objective was to support the fight against counterfeit medicines. The new Directive had a big influence on the pharmaceutical supply chain. It introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had
The European Medicines Agency (EMA) have released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation. This guideline provides guidance on the documentation expected for Drug-Device Combinations in the quality part of the dossier
Medicinal cannabis is being made available under a pilot programme. The pilot programme which allows access to cannabis-based products for medical use has been launched by the Minister for Health, Simon Harris. Legislation giving the go ahead for the Medical Cannabis Access Programme to operate in Ireland was signed yesterday by Simon
Why do you need a QP? According to European regulations, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years
The European Medicines Agency (EMA) announced on Tuesday that Luxembourg and The Netherlands have now joined the mutual recognition agreement for Good Manufacturing Practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states. This announcement comes six months after Cyprus and Bulgaria joined the agreement. The MRA,
MIAS Pharma Limited, your European Partner, provides contract QP services to enable you to import and QP Release human medicinal products into Europe in a compliant manner. Watch our CEO, Ann McGee, provide a high-level overview of our service offering. If you would like to get in touch
Construction has begun on the €325m WuXi Biologics plant in Dundalk which aims to be the world’s largest single-use biologics manufacturing facility. WuXi Biologics is Chinas leading end-to-end biologics solutions provider with the Dundalk campus and is set to be its first manufacturing facility outside China. The build is on schedule for
With the Mutual Recognition Agreement (MRA) between Europe and the USA, inspections are to be mutually recognised in the future. The Food & Drug Association (FDA) approval of EU member states continue to proceed successively. Two more countries have recently been approved, they are Bulgaria and Cyprus. That means there is now
The European Medicines Agency (EMA) protects patients to ensure they are safe. The EMA accesses, supervises and monitor medicines before they can appear in hospitals and pharmacies. The agency monitors information on side effects reports from doctors, pharmacists, patients, new clinical studies and new scientific publications. This data will be reviewed by
The EudraVigilance database is used for the Europe-wide registration and analysis of adverse reactions to medicinal products authorized within the EU. EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).
