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4 07, 2019

Serialisation: New Guidance for EU Inspectors

By |2022-10-25T16:07:59+00:00July 4th, 2019|Industry News|

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

1 07, 2019

EMA’s quality guideline for drug device combinations

By |2019-07-01T13:47:50+00:00July 1st, 2019|Industry News|

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

27 06, 2019

Medicinal cannabis now being made available under a pilot programme

By |2019-06-27T12:07:36+00:00June 27th, 2019|General News|

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

18 06, 2019

The Role Of The QP In Europe

By |2019-06-18T11:45:53+00:00June 18th, 2019|Technical Article|

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

13 06, 2019

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands

By |2019-06-13T13:24:29+00:00June 13th, 2019|General News|

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,

4 06, 2019

Construction begins on WuXi Biologics plant

By |2022-10-25T16:18:30+00:00June 4th, 2019|Uncategorized|

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

24 05, 2019

EU – FDA MRA has approved two more countries

By |2019-05-24T13:32:15+00:00May 24th, 2019|Industry News|

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

8 05, 2019

Working together for safe medicines in the EU

By |2019-05-08T12:40:46+00:00May 8th, 2019|Industry News|

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

26 04, 2019

EMA’s Report on the EudraVigilance Database

By |2022-10-26T09:32:56+00:00April 26th, 2019|Industry News|

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).

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