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As part of the Accelerating Clinical Trials in the EU (ACT EU) programme, you will have the opportunity to participate in the upcoming EU multi-stakeholder workshop on 23 November 2023 in Amsterdam to discuss selected clinical trial methodology topics. Stakeholders are invited to express their interest for participation to the workshop via the EU survey until 17 September 2023.

DKMAnet is not yet ready to support MitID Erhverv. It is therefore IMPORTANT to keep your NemID employee signature, as it is the only way to access DKMAnet until the transition to MitID Erhverv is completed.

The Danish Medicines Agency has established new criteria for when companies must notify medicines supply shortages. The new criteria make it easier for the companies to know when and for which medicinal products they must notify supply shortages, and a new form has made notification even easier.

Multi-factor (MFA) authentication for user logins to Clinical Trial Information Systems (CTIS), for both Sponsor and Member State workspaces, will be launched on 1 June 2023.

Under Commission Implementing Regulation EU 202116 of 8 January 2021, all Marketing Authorisation Holders of Veterinary Medicinal products in the EU, must register information on Qualified Persons for Pharmacovigilance QPPV and Pharmacovigilance System Master File PSMF in the Union Product Database UPD.

The European Commission has reached a decision in the case about the bioequivalence company Synchron Research, deciding that a number of generic medicines must be suspended in the EU counties where they are authorised. The Danish Medicines Agency therefore suspends the marketing authorisations of four medicines.

As part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) are establishing a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform will support discussions across the clinical research landscape and facilitate the evolution of clinical trial methods and approaches.

Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine.

In order to improve the companies' possibility to follow the status of their submitted variations, the Danish Medicines Agency is expanding its order book for variations to include all national type I

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2023.

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).

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.

Applications for import/export certificates submitted via NDS Web must reach us by 16 December 2022 to be reviewed before Christmas.

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.

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

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

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.

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.

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

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.