29 May 2012 | Updated 27 June 2012 /Legislation
New European legislation improves the monitoring of adverse reactions and strengthens patient safety
In July 2012, new pharmacovigilance legislation comes into effect across the EU. The purpose of the new legislation is to strengthen patient safety by improving the present system used for monitoring safety of medicines in Europe.
25 June 2012 /Legislation
On 20 June 2012, the European Commission's Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council was published in the Official Journal of the European Union.
27 January 2012 /Legislation
In recent years, we have seen a sharp rise in the number of applications whereby doctors request permission to cooperate with a pharmaceutical company. The increase follows the Danish Medicines Agency's persistent efforts through awareness-raising campaigns and new legislation.
30 June 2011 /Legislation
More doctors must apply for authorisation to cooperate with the pharmaceutical industry from 1 July 2011
If a Danish doctor or dentist wishes to establish a relationship with, be employed at, or run a pharmaceutical company and at the same time prescribe medicines to patients, he or she must apply to the Danish Medicines Agency for permission to do so. An amendment to the Danish Pharmacy Act as of 1 July 2011 means however that in future, Chief Medical or Dental Officers who do not prescribe medicine will in certain cases also be comprised by the Act.