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FlensborggadeGade Cecere neziri Galten 8464 59010174 Linds

59010174

brugere rapporterede dette som svindel 004559010174

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5901-0174 Linds Rapporterede numre

FlensborggadeGade
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Galten 8464
59010174
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5901-0174
59010174
004559010174
+4559010174
tel:+4559010174
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9010174
59010174
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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

Land Vejledende Nummer
Frankrig 33 +339010174
Tyskland 49 +499010174
England 44 +449010174
Spanien 34 +349010174
Italien 39 +399010174
Schweiz 41 +419010174
Portugal 351 +3519010174
Holland 31 +319010174
Belgien 32 +329010174
Marokko 212 +2129010174
Tunesien 216 +2169010174
Algeriet 213 +2139010174
Irland 353 +3539010174
Elfenbenskysten 225 +2259010174
Mali 223 +2239010174
Danmark 45 +459010174
Rusland 7 +79010174
Kina 86 +869010174
Mexico 52 +529010174
Tjekkiet 420 004209010174
Moldova 373 003739010174
Malta 356 +3569010174
Luxembourg 352 +3529010174
Bosnien 387 +3879010174
Hviderusland 375 +3759010174
Norge 47 +479010174
Bulgarien 359 +3599010174
Ukraine 380 +3809010174
Slovakiet 421 +4219010174