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Kristianiagade Nafal hilde Sønder Omme 7260 85406357 Nettalk

85406357

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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
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20th 2022. The Danish Medicines Agency is closed for the Holiday Season, from December 24th, 2022, until January 1st, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before December 20th, 2022. We will consider applications submitted after December 20th, 2022, as if they have been received January 2nd 2023.

Current Danish QRD template to be used in connection with the granting of marketing authorisations
Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as w

Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users
Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions in advance (see tabel below) concerning organisation and site registration in OMS.

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.
New and innovative clinical trial designs and methodologiesprovide opportunities and challenges for the EU clinical trials environment. The EU decentralised clinical trials (EU DCT) project aims to address some of these challenges, in line with the European Medicines Agencies Network Strategy to 2025 and European Commission’s Pharmaceutical Strategy for Europe. Since March 2022, the Clinical Trials Coordination Group (CTCG) under the Heads of Medicines Agencies (HMA) have been responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project, with Ditte Zerlang Christensen of the Danish Medicines Agency (DKMA) as the project manager. The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be an onsite meeting hosted by EMA on October 4th 2022. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.

Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals
The last days of June saw the roll out of the 2022 version of the Interpol-managed Operation Pangea XV – a global initiative targeted illegal trade with medicines and medical devices. The Danish Medic

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.

Land Vejledende Nummer
Frankrig 33 +335406357
Tyskland 49 +495406357
England 44 +445406357
Spanien 34 +345406357
Italien 39 +395406357
Schweiz 41 +415406357
Portugal 351 +3515406357
Holland 31 +315406357
Belgien 32 +325406357
Marokko 212 +2125406357
Tunesien 216 +2165406357
Algeriet 213 +2135406357
Irland 353 +3535406357
Elfenbenskysten 225 +2255406357
Mali 223 +2235406357
Danmark 45 +455406357
Rusland 7 +75406357
Kina 86 +865406357
Mexico 52 +525406357
Tjekkiet 420 004205406357
Moldova 373 003735406357
Malta 356 +3565406357
Luxembourg 352 +3525406357
Bosnien 387 +3875406357
Hviderusland 375 +3755406357
Norge 47 +475406357
Bulgarien 359 +3595406357
Ukraine 380 +3805406357
Slovakiet 421 +4215406357