News items 2015
| 28 May 2014 |
The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 websites were shut down or had their payment facility removed.
| 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.
| 07 May 2014 |
In the April issue of Danish Pharmacovigilance Update:
| 06 May 2014 |
The EU Pharmacovigilance Risk Assessment Committee (PRAC) recently completed a review of the risk of blood clots (VTE) with contraceptive pills and other combined hormonal contraceptives. Combined hormonal contraceptives contain two types of hormone, oestrogen and progesterone, and are available as pills, transdermal patches and vaginal rings.