New position on covert advertising targeting social media advertising in the Nordics
22.08.2016At any time, a consumer must be able to realize when he or she is being exposed to advertising – regardless of the form of the advertising and in which media the advertising appears.
New EU rules for medical devices
22.08.2016In May 2016, negotiations between the Dutch Presidency and the EU Parliament led to the agreement of two proposals for new EU regulations; one on medical devices and one on in vitro diagnostic medical devices. The regulations cover a broad spectrum of products in use for treatment and diagnosis, e.g. band aids, hip replacements, pacemakers, pregnancy tests etc.
A new Act on Marketing Practices is taking form in Denmark
22.08.2016In July 2016, the Danish Minister of Business and Growth has introduced a bill for a new Danish Marketing Practices Act.
New Danish act on clinical trials of medicine to take effect in 2018
22.08.2016In May 2016, the Danish Parliament adopted a new act on clinical trials of medicine to accommodate EU Regulation 536/2014 on clinical trials on medicinal products for human use. The Danish act will enter into force in October 2018, when the EU Regulation also enters into force, and brings substantial amendments to the Danish clinical trial application system as we know it today in Denmark.
PRAC will now take the public’s views on safety of medicines into account
22.08.2016The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), the committee responsible for assessing all aspects of the risk management of medicines for human use in the EU, has adopted rules of procedure for public hearings and may now consider the views of the public in connection with supervision of medicines.