Focus on Regulatory Affairs in 2016


Now it is 2016 - another year with challenges and business as usual


DKMA re-emerged

The “Lægemiddelstyrelsen” – Danish Medicines Agency – has re-emerged in the end of 2015. Good news, as we again will get back to have an authority focusing on medicine.

However this re-emerging also just by the name change from “Sundhedsstyrelsen” to “Lægemiddelstyrelsen” gives challenges to the MAHs, as you must reflect this change and once again revise the sections on reporting side effects in all SmPCs and PILs before 08-Oct-2018.

Unique identifier and anti-tampering

One of the ongoing / new issues that are only partly regulatory, but will impact the work in the regulatory departments is the implementation of the measures to help protect patients from falsified medicines. The delegated regulation to introduce two safety features, a unique identifier in form of the 2D barcode (including a human readable presentation of the information) and an anti-tampering device to be placed on the outer packaging of most Rx-medicines for human use was finally published here in February. The features have to be implemented by 09-Feb-2019. Hopefully the Danish Medicines Agency will hurry up and update the Danish regulation and guidelines to reflect these changes, as there are many issues to be met before the timeline (3 years runs fast).


Most companies are probably working on the implementation of the ISO IDMP standards (Identification of Medicinal Products), where one of the initial challenges is to investigate where in the company the requested information is stored. With a starting time of July 2016, many are in a hurry now to be ready for reporting all the information to the EMA.


Even with these newer challenges one should not forget the focus on regulatory compliance - and the variations necessary to reach/maintain this. Or the need to help patients even better by developing new products.

Changes can be brought upon you from the outside or internally from the company – e.g. as changes in production facilities or mergers, which all require variations with the prior update of documentation and product information.

If you are meeting any of these – and/or other regulatory affairs challenges, we’ll be happy to help you – with big projects, smaller parts or just some of your daily work to set you free to do the projects

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