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Frederiksberg C 1965
25560329
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25560329
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Change of practice for the Danish Medicines Agency’s inspections
The Danish Medicines Agency is now implementing the digital signing system called Penneo. As of 1 November 2022, we will be using digital signatures to sign all inspection reports.

2022 deadline for submitting applications concerning marketing authorisations and clinical trials
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Current Danish QRD template to be used in connection with the granting of marketing authorisations
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Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users
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Expression of interest for onsite participation in ACT EU workshop on Decentralised Clinical Trial guidance on October 4th 2022 – Response deadline is September 06th 2022.
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Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals
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New Data Ethics Charter provides a framework for the Danish Medicines Agency’s use of health data
The Danish Medicines Agency has adopted a Data Ethics Charter consisting of seven principles of data ethics. The charter is to set high ethical standards for the protection and handling of the health data included in the scientific and statistical analytical work performed by the agency.

The Danish Medicines Agency will be closed on Friday 10 June 2022
The Danish Medicines Agency will be holding its staff convention and will be closed on  Friday 10 June 2022 However, we process urgent applications for compassionate use permits (applications for d

New executive order raises fees in the area of the Danish Medicines Agency
Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.

Management of clinical trials in light of the current situation in Ukraine
The current situation in Ukraine can have an impact on the conduct of clinical trials. It can affect both the supply of trial-related drug products and the collection of critical data. Therefore, an initial guidance on the management of clinical trials in light of the situation have been issued by the European Commission (EC), the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTCG).

Danish Medicines Agency presents new strategy
Lars Bo Nielsen, Director General of the Danish Medicines Agency, announces new 2022-26 strategy for the agency. The strategy supports the Danish Ministry of Health’s joint corporate strategy and emphasises a vision to lead national and international collaboration, for example regarding better use of data and new technology and dialogue with public and society in general.

Land Vejledende Nummer
Frankrig 33 +335560329
Tyskland 49 +495560329
England 44 +445560329
Spanien 34 +345560329
Italien 39 +395560329
Schweiz 41 +415560329
Portugal 351 +3515560329
Holland 31 +315560329
Belgien 32 +325560329
Marokko 212 +2125560329
Tunesien 216 +2165560329
Algeriet 213 +2135560329
Irland 353 +3535560329
Elfenbenskysten 225 +2255560329
Mali 223 +2235560329
Danmark 45 +455560329
Rusland 7 +75560329
Kina 86 +865560329
Mexico 52 +525560329
Tjekkiet 420 004205560329
Moldova 373 003735560329
Malta 356 +3565560329
Luxembourg 352 +3525560329
Bosnien 387 +3875560329
Hviderusland 375 +3755560329
Norge 47 +475560329
Bulgarien 359 +3595560329
Ukraine 380 +3805560329
Slovakiet 421 +4215560329