• Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)
    Håkon Austdal Associate/Bachelor of Pharmacy

    Medicinal products – implementation of Regulation 712/2012/EC in Norway

    02/04/2013

    The Ministry of Health and Care has issued a hearing letter proposing the implementation of Regulation 712/2012. One of the consequences will be reduced time frames for applications for type IB and type II variations.

  • Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)
    Håkon Austdal Associate/Bachelor of Pharmacy

    Pricing of medicinal products in Norway – an overview

    14/01/2013

    The price level of medicinal products was a hot topic for the pharmaceutical sector in Europe in 2012, as the financial crisis made governments cut spending and slash prices on medicinal products. The Norwegian economy has largely been left unscathed by the crisis, but prices on pharmaceutical products are amongst the lowest in Europe.

  • Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)
    Håkon Austdal Associate/Bachelor of Pharmacy

    Advertising of Pharmaceuticals – recent decisions from the Board

    11/01/2013

    Advertising of medicinal products is governed by the Act on Medicinal Products of 4th December 1992 and by the appurtenant Regulation on medicinal products of 18th December 2009. In addition to these rules, the Association of the Pharmaceutical Industry (LMI) has provided several codes of practice for its members. Most notably are the Rules for marketing of medicinal products, which is largely based on EFPIA’s Code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals.

  • Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)

    Automatic substitution of biologicals in Norway

    15/11/2012

    When you lose in court, you may appeal the decision, or you may choose to just change the rules that made you lose. The latter seem to be the case for the Norwegian Medicines Agency (NOMA) in a case regarding automatic substitution of biologicals.

  • Amund Brede Svendsen Partner
    Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)

    Stem cells and patents – Norwegian patent office amends its guidelines

    13/11/2012

    The EPO changed its guidelines in June 2012 and on the 24th of October 2012 the Norwegian Patent Office amended its patent guidelines. Here follows a brief outline of the amendments in Norway.

  • Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)

    Biotech patents in Norway: Amendment, but little harmonization in sight

    25/09/2012

    In Norway there is a fear that the dangerous patent creature shall play with the even more dangerous biotechnology creature. This fear is prominent among some groups of politicians and within some NGOs. After prolonged public debate, Norway implemented the biopatent directive 1st January 2004. However, special means should ensure that the adverse effects of the directive were not too large. One of these means was that the patentability requirements should be practiced so strictly that Norway would be among the strictest European countries.

  • Inga Kaasen Partner/Attorney-at-law/PhD (biotechnology)
    Håkon Austdal Associate/Bachelor of Pharmacy

    Proposed ban on personal import of medicinal products ordered via Internet

    06/09/2012

    The Ministry of Health and Care has recently issued a hearing letter proposing stringent restrictions on import of medicinal products for personal use. Among the actions proposed, is a general ban on the import of prescription drugs, and access for Customs to seize and destroy falsified or illegal medicinal products.

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