News about company authorisations and registrations
| 21 October 2014 |
We have updated our guidelines on activities subject to a section 39 authorisation or a company registration.
| 03 June 2014 |
On 30 May 2014, the substances below were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.
| 09 May 2014 |
The Danish Health and Medicines Authority has updated the guidelines on requirements and expectations for the qualified person (QP) in a pharmaceutical company. The requirements for the QP have not been changed compared to the previous guidelines. The new guidelines have mainly been updated to include the requirements for the duration of the QP's education as specified in the applicable directives. In addition, a number of other updates and specifications have been made that you can read more about in this news item.
| 12 February 2014 |
The Danish Health and Medicines Authority has updated the Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA.
| 27 January 2014 |
The guidelines on good distribution practice of medicinal products for human use came into force on 7 September 2013. Read our questions and answers to the guidelines.
| 15 January 2014 |
On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).