Deadline for applications for export certificates for medicines in 2022

By Admin 02/12/2022

Danish Medicines Agency 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 Go to Source December 2, 2022 – 12:08 pm / Twitter: @hoffeldtcom

Deadline for submission of applications for medical device export certificates in 2022

By Admin 02/12/2022

Danish Medicines Agency 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. Go to Source December 2, 2022 – 12:08 pm / Twitter: @hoffeldtcom

Change of practice for the Danish Medicines Agency’s inspections

By Admin 04/11/2022

Danish Medicines Agency 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. Go to Source November 4, 2022 – 3:04 pm / Twitter: @hoffeldtcom

2022 deadline for submitting applications concerning marketing authorisations and clinical trials

By Admin 19/10/2022

Danish Medicines Agency 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 […]Continue reading

Current Danish QRD template to be used in connection with the granting of marketing authorisations

By Admin 11/10/2022

Danish Medicines Agency 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 Go to Source October 11, 2022 – 6:06 pm / Twitter: @hoffeldtcom

Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users

By Admin 08/09/2022

Danish Medicines Agency 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 […]Continue reading

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.

By Admin 08/09/2022

Danish Medicines Agency 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 […]Continue reading

Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals

By Admin 21/08/2022

Danish Medicines Agency 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 Go to Source August 21, 2022 – 10:31 pm / Twitter: @hoffeldtcom

New Data Ethics Charter provides a framework for the Danish Medicines Agency’s use of health data

By Admin 21/08/2022

Danish Medicines Agency 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. Go to Source August 21, 2022 […]Continue reading

The Danish Medicines Agency will be closed on Friday 10 June 2022

By Admin 21/08/2022

Danish Medicines Agency 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 Go to Source August 21, 2022 – 10:31 pm / Twitter: @hoffeldtcom