News from the Danish Medicines Agency and EMA
Keep up to dates with all news from The Danish Medicines Agency and EMA. Links to news are as follows: Danish Medicines Agency EMA – European Medicines Agency READ MORE
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News
GMP NEWS FROM EMA
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EMA has published a new Guidance on the sterilization of the medicinal product, active substance, excipient and primary container. The purpose of this document is to provide guidance on the selection of appropriate sterilization methods for sterile products. In general, terminal... READ MORE
Data Integrity
In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity. Different authorities have published draft guidelines: In April 2016, the FDA issued a first draft Guidance for Industry, “New FDA Draft Guidance Data... READ MORE
GDP news – Many so-called “GDP certificates” are issued. But what are the requirements?
With the publication of the new GDP Guideline in 2013 the legal requirements concerning the Good Distribution Practice increased throughout the complete legal distribution chain from manufacturing and release to distribution to the patient. The competent supervisory authorities... READ MORE
New GDP legislation soon to be published
New Danish GDP legislation will soon be in published. As soon as the Executive Order is in force, we’ll tell more about it the changes on this page. Contact us READ MORE