The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
Did you know that Article 20 of Commission Regulation, known as the ‘Variations Regulation, allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one...
Our WDA E-Book Is Available To Download Now
The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. For many, the issue of Brexit has ‘muddied the water’ somewhat. Anecdotal evidence would suggest that there has been a...
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Is Well Established Use Going Out of Fashion?
The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make. One of the choices available, ‘well established use’ seems to waning in popularity as a choice amongst MAH’s. Here, we look...
Four New Countries Join The EU – US Mutual Recognition Agreement for Manufacturing Sites
Four new entrants joined the EU-US Mutual Recognition Agreement for manufacturing sites for human medicines on March 1st. The four additional countries: Czech Republic, Romania, Greece and Hungary now join the eight existing members of the agreement.
Preparing the Reference Safety Information for a Clinical Trial
What are the steps that companies need to take when preparing the reference safety information for a clinical trial? This article looks at the steps that you need to take.
Brexit Information for the Pharmaceutical Sector
In this blog we look at a number of Brexit information resources for the pharmaceutical sector.
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How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
Blog: The 30% Club Report & Women in Life Sciences
In this blog, Dr. Gemma Robinson looks at the recent 30% Club report and the similarities that can be drawn between the financial services and life sciences sector in attracting and retaining female participation in the workforce. What can be...
How Are Changing Regulatory Demands Impacting You?
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In...
How Will Brexit Impact UK Marketing Authorisation Holders?
The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union. In this article we look at one of the main questions highlighted by the...
