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Nørre Asmindrup 4572
89829089
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Første søgedato : 25/07/2018 09:17:29
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Applications for compassionate use permits on weekdays between Christmas and New Year
The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 2 January 2023. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).

Notification of medicine price and assortment changes between Christmas and New Year
The Danish Medicines Agency is closed between Christmas and New Year. This means that there is no support regarding notification of medicine price and assortment changes from Monday 26 December 2022 to and including 30 December 2022.

Deadline for applications for export certificates for medicines in 2022
Applications for export certificates for medicines must be received by 14 December 2022 at the latest if they are to be processed before Christmas. Applications submitted after 22 December will be c

Deadline for submission of applications for medical device export certificates in 2022
The last day for submitting an application for a medical device export certificate will be 14 December 2022. Any application received after that will be considered received on 1 January 2023.

The deadline for receipt of applications for company authorisations is 22 December in 2022
Applications for company authorisations will be received no later than December 22, 2022. Applications received after this date will be considered received on January 2, 2023. Fee rates and exceptio

Deadlines to apply for the issuance of import or export certificates for euphoriant substances before Christmas
Applications for import/export certificates submitted via NDS Web must reach us by 16 December 2022 to be reviewed before Christmas.

Danish Medicines Agency closed over Christmas and New Year
The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 24 December 2022 to Sunday 1 January 2023, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2022.

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

Land Vejledende Nummer
Frankrig 33 +339829089
Tyskland 49 +499829089
England 44 +449829089
Spanien 34 +349829089
Italien 39 +399829089
Schweiz 41 +419829089
Portugal 351 +3519829089
Holland 31 +319829089
Belgien 32 +329829089
Marokko 212 +2129829089
Tunesien 216 +2169829089
Algeriet 213 +2139829089
Irland 353 +3539829089
Elfenbenskysten 225 +2259829089
Mali 223 +2239829089
Danmark 45 +459829089
Rusland 7 +79829089
Kina 86 +869829089
Mexico 52 +529829089
Tjekkiet 420 004209829089
Moldova 373 003739829089
Malta 356 +3569829089
Luxembourg 352 +3529829089
Bosnien 387 +3879829089
Hviderusland 375 +3759829089
Norge 47 +479829089
Bulgarien 359 +3599829089
Ukraine 380 +3809829089
Slovakiet 421 +4219829089