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43959718 Talværdi
43959718 Lede efter
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43 95 97 18 Lede efter
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43959718 Lede efter
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49325784

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39824253

92613769

24967893

33205840

81401958

39115615


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Douglas Pl
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Ørnhøj 6973
43959718
3 (Tre)

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43959718
43-95-97-18
43 95 97 18
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0045 43 95 97 18
(439)59718
(4395)9718
4395-9718
43959718
004543959718
+4543959718
tel:+4543959718
tel:004543959718
3959718
43959718
3 (Tre)
Ørnhøj 6973



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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.

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).

Land Vejledende Nummer
Frankrig 33 +333959718
Tyskland 49 +493959718
England 44 +443959718
Spanien 34 +343959718
Italien 39 +393959718
Schweiz 41 +413959718
Portugal 351 +3513959718
Holland 31 +313959718
Belgien 32 +323959718
Marokko 212 +2123959718
Tunesien 216 +2163959718
Algeriet 213 +2133959718
Irland 353 +3533959718
Elfenbenskysten 225 +2253959718
Mali 223 +2233959718
Danmark 45 +453959718
Rusland 7 +73959718
Kina 86 +863959718
Mexico 52 +523959718
Tjekkiet 420 004203959718
Moldova 373 003733959718
Malta 356 +3563959718
Luxembourg 352 +3523959718
Bosnien 387 +3873959718
Hviderusland 375 +3753959718
Norge 47 +473959718
Bulgarien 359 +3593959718
Ukraine 380 +3803959718
Slovakiet 421 +4213959718