Articles on regulation and compliance within the pharma industry

Will the EMVO and the NVOs be ready to support the FMD?

Medicine manufacturers have been working hard with serialisation vendors to comply with requirements under the Falsified Medicines Directive (FMD) of 2011 which specifies safety features for packaging used on medicines.  To be compliant individual medicine packs (the lowest saleable unit) must carry a unique identifier (UI) or serial number displayed as human readable text and embedded within a machine readable 2D matrix.  The product must also contain anti-tamper evidence.  This process alone has proven

Hear from EUFMD expert Dan Anslow at Making Pharmaceuticals 2018

Achieving compliance with EUFMD

During his talk, Dan will share a series of key insights based on the experiences he has witnessed with customers implementing solutions for Serialisation & Aggregation.

From Large Pharma to CMO, Dan has first-hand knowledge of the realities of achieving compliance for regulation on Track & Trace, in particular the EU Falsified Medicines Directive.

Achieving compliance with the EU Falsified Medicines Directive – what you need to know

Effective in Europe from February 2019, EU directive 2011/62/EU, also referred to as EU FMD, aims to reduce counterfeiting of prescription drugs by tracking and tracing the passage of drugs through the entire supply chain.

Under the Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a verifiable unique identifier (serialised code) and an anti-tamper device.

One Year to EU FMD: How to Achieve Compliance in Time

Here's a month-by-month break down on how to comply and optimise your pharmaceutical packaging lines before 09 February 2019.

One Year for EU FMD Implementation: A month-by-month guide to compliance

With one year to go for pharmaceutical manufacturers, packaging sites and Marketing Authorisation Holders (MAHs) to achieve compliance with the Falsified Medicines Directive, the team in Crest Solutions have put together this guide to help you meet the deadline.