News about licensing of medicines
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Medicines of the future in focus at World Economic Forum
| 20 September 2018 |
Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.
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Brexit, change of Reference Member State from UK to DK
| 01 February 2018 |
The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.
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Theme event on big data and medicine
| 08 November 2018 |
The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.
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Danish Medicines Agency launches new concept for National Scientific Advice
| 31 August 2018 |
Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.
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New format requirements for Marketing Authorization submissions from 1 January 2019
| 17 December 2018 |
The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.
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Updating of summaries of product characteristics due to changed ATC codes for 2018
| 18 January 2018 |
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 2018.
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All marketing authorisation letters are now sent electronically to Danish companies
| 01 March 2018 |
On 20 February 2018, the Danish Medicines Agency extended its use of digital post and now sends all letters, and not just decisions, about marketing authorisations electronically to Danish companies.