News about Licensing and supervision
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Manufacturers and wholesale distributors must be contactable outside opening hours
| 22 September 2016 |
The Danish Medicines Agency will make calls to companies' main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.
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All Danish Wholesale Distribution Authorisations now appear from EudraGMDP
| 16 September 2016 |
All Danish Wholesale Distribution Authorisations have been updated to the applicable European format and entered into the common EU database, EudraGMDP, which is available to the general public.
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New Danish member of the CHMP
| 06 September 2016 |
Sinan B. Sarac, Medical Doctor, is Denmark's new member of the CHMP, the European Medicines Agency's committee for the authorisation of medicines for human use.
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Improved access to patient data in clinical trials for monitors and GCP inspectors
| 05 September 2016 |
The Danish Medicines Agency's inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.