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62851933 Talværdi
62851933 Lede efter
62-85-19-33 Lede efter
62 85 19 33 Lede efter
62.85.19.33 Lede efter
0045 62 85 19 33 Lede efter
(628)51933 Lede efter
(6285)1933 Lede efter
6285-1933 Lede efter
62851933 Lede efter
004562851933 Lede efter
+4562851933 Lede efter
tel:+4562851933 Lede efter
tel:004562851933 Lede efter

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39358951

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35511450

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21661939

26772626

71863992

42513727

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93051390

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59382795

36063752


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Pinniger Point Rd Montermini gaston ner Frederiksberg C 1908 62851933

62851933

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202.109.91.47
100.7.5.25
90.87.24.204
170.167.81.81
15.12.6.39

6285-1933 Rapporterede numre

Pinniger Point Rd
Montermini
gaston ner
Frederiksberg C 1908
62851933

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62851933
62-85-19-33
62 85 19 33
62.85.19.33
0045 62 85 19 33
(628)51933
(6285)1933
6285-1933
62851933
004562851933
+4562851933
tel:+4562851933
tel:004562851933
2851933
62851933

Frederiksberg C 1908



Første søgedato : 19/02/2018 16:01:11
Sidste søgedato : 27/11/2022 14:27:30

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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.

Land Vejledende Nummer
Frankrig 33 +332851933
Tyskland 49 +492851933
England 44 +442851933
Spanien 34 +342851933
Italien 39 +392851933
Schweiz 41 +412851933
Portugal 351 +3512851933
Holland 31 +312851933
Belgien 32 +322851933
Marokko 212 +2122851933
Tunesien 216 +2162851933
Algeriet 213 +2132851933
Irland 353 +3532851933
Elfenbenskysten 225 +2252851933
Mali 223 +2232851933
Danmark 45 +452851933
Rusland 7 +72851933
Kina 86 +862851933
Mexico 52 +522851933
Tjekkiet 420 004202851933
Moldova 373 003732851933
Malta 356 +3562851933
Luxembourg 352 +3522851933
Bosnien 387 +3872851933
Hviderusland 375 +3752851933
Norge 47 +472851933
Bulgarien 359 +3592851933
Ukraine 380 +3802851933
Slovakiet 421 +4212851933