UPDATE: No votes for the Danish Medicines Agency or the Danish Health Authority
05.12.2016When the new Medicine Committee will start operating in 2017 there will be no voting rights for the Danish Medicines Agency (DMA) or the Danish Health Authority (DHA) when it comes to the decision-making on prioritizing medicines. Further, there will be no complaints board or appeal option.
Revision of EMA’s guideline on first-in-human clinical trials: Open for public consultation
05.12.2016To further improve safety of trial participants, the European Medicines Agency (EMA) has in cooperation with the European Commission and the EU Member States changes to the existing guideline on first-in-human clinical trials.
UPDATE: The European Medicines Agency provides public access to clinical reports
05.12.2016Following DELACOUR’s newsletter of March 2016, in which EMA’s policy on publication of clinical data was the topic, the European Medicines Agency (EMA) has made its new database available to the public containing data from various clinical trials.
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.
UPDATE on the Medicine Committee (Medicinrådet)
07.04.2016In our recent life science newsletter of March 2016 we reported on the plan for a new scheme for prioritizing medicine expenditure in Denmark. Danish Regions and Danish Parliament have now reached an agreement on the principles of the establishment of the Medicine Committee (Medicinrådet).
Medical devices: Revised ISO-standard for quality management
07.04.2016For the first time in more than 12 years, the international recognized ISO standard for medical devices quality management systems has been revised into a 2016 standard, named ISO 13485:2016.
Trade marks: The effects of new rules for European Union Trade Marks
07.04.2016New rules on European Union Trade Marks (EUTMs) have been in force for two weeks. Also life science companies must be aware of the effects of this new regulation.
EMA launches new scheme PRIME for medicines that target unmet medical needs
09.03.2016On 4 March 2016, the European Medicines Agency (EMA) launched PRIME (PRIority MEdicines), a priority scheme to support medicinal products benefiting patients with no treatment options or offering a significant therapeutic advantage over existing treatments.
News from the EU on transparency of clinical data
09.03.2016The European Medicines Agency (EMA) publishes guidance on EMA policy on the publication of clinical data.
Extension of ENLI’s authority
09.03.2016As of 1 February 2016, the Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has been given authority to control and impose sanctions on pharmaceutical companies that do not comply with the regulations pertaining to the clinical testing of pharmaceuticals and non-interventional studies.
The Danish Regions’ plan for prioritizing medicine expenditure
09.03.2016At a press conference on 5 February 2016, the Danish Regions presented their new model for the assessment of medicine. As part of the implementation of the new model, a new prioritization structure will be established and this will likely be named the Medicine Committee.
The British Government intends to reform legislation on the tax liability of individuals “resident non-domiciled”
Tax 13.01.2016A proposed amendment of the British legislation on tax liability means that Danes, who for a considerable number of years have been taxed as “resident”, will now be taxed according to a principle of global in-come.