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23.10.2018Letter to stakeholders regarding the implementation of safety features
European Commission together with European Medicines Agency and HMA announce an important message to all stakeholders regarding the implementation of…
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News
23.10.2018
31.08.2018The amendment to the Pharmaceuticals Act with modifications related to FMD was approved by the Government on August 22, 2018
The Government approved an amendment to the Act on Pharmaceuticals (No. 378/2007 Coll.), which aims to enable the functioning of the anti-counterfeiting…
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31.08.2018Discount from User fee for Marketing authorisation holders with very low revenue
Based on the NOOL Board’s proposal a reduction of the User fee for 2019 for MAHs with very small or zero revenues was approved by General Meeting…
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09.08.2018Letter of announcement - notice of the on-boarding on time
In January 2018, EMVO announced that the very last opportunity to on-board timely is June 2018. Any on- boarding after that date may entail a risk to…
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