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So far Richie D has created 27 blog entries.

GMP Requirements in the European Union

2019-07-19T12:43:01+01:00

GMP Requirements in the EU: The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world. To import a product into the EU you must abide by European GMP requirements. There is [...]

GMP Requirements in the European Union2019-07-19T12:43:01+01:00

A milestone has been reached by the EU and US (MRA)

2019-07-17T11:28:47+01:00

With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. Each year, EU national authorities and the FDA inspect many [...]

A milestone has been reached by the EU and US (MRA)2019-07-17T11:28:47+01:00

Canada’s Cannabis Products: New Regulatory Approach

2019-07-11T11:10:55+01:00

Health Canada has proposed a regulatory pathway for a new class of cannabis products known as Cannabis Health Products (CHPs). On June 19, 2019, Health Canada started a consultation on potential market for CHPs that would not require a practitioner’s oversight. Health Canada are accepting comments until September 3, 2019. There is [...]

Canada’s Cannabis Products: New Regulatory Approach2019-07-11T11:10:55+01:00

Serialisation: A New Guidance for EU Inspectors

2019-07-04T10:46:36+01:00

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 [...]

Serialisation: A New Guidance for EU Inspectors2019-07-04T10:46:36+01:00

EMA’s quality guideline for drug device combinations

2019-07-01T13:47:50+01:00

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 [...]

EMA’s quality guideline for drug device combinations2019-07-01T13:47:50+01:00

Medicinal cannabis now being made available under a pilot programme

2019-06-28T13:55:16+01:00

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 [...]

Medicinal cannabis now being made available under a pilot programme2019-06-28T13:55:16+01:00

The Role Of The QP In Europe

2019-06-18T11:45:53+01:00

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 Role Of The QP In Europe2019-06-18T11:45:53+01:00

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands

2019-06-13T13:24:29+01:00

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, [...]

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands2019-06-13T13:24:29+01:00

MIAS Pharma Ltd Services Overview

2019-06-13T13:26:00+01:00

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 [...]

MIAS Pharma Ltd Services Overview2019-06-13T13:26:00+01:00

Construction begins on €325m WuXi Biologics plant in Dundalk

2019-06-04T14:57:57+01:00

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 [...]

Construction begins on €325m WuXi Biologics plant in Dundalk2019-06-04T14:57:57+01:00

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