Q2 2026 brought significant legal and regulatory developments in life sciences across Norway and the EU. This quarterly update examines recent case law from the CJEU affecting distributor obligations under the MDR, online sales of non-prescription medicines, and SPC protection for substances classified as excipients, alongside regulatory updates including the provisional agreement on the Critical Medicines Act and EUDAMED becoming mandatory as of 28 May 2026.

Norway (in addition to Finland) only accepted product patents on active ingredients in medicaments from 1. January 1992.

Regulation (EU) 1235/2010 and Directive 2010/84/EU amending the legal framework regarding pharmacovigilance for medicinal products will enter into force in the European Union in July 2012.

On 24th November 2011 the Court of Justice of the European Union released its important decisions in the two cases Medeva (Case C-322/10) and Georgetown (Case C-422/10).

Norwegian companies actively developing ground-breaking new technologies to meet the world's growing demand for more sustainable foods and more environmentally...

When you lose in court, you may appeal the decision, or you may choose to just change the rules that made you lose.

The Advocate General Jàn Mazák today delivered his opinion in the AstraZeneca case. AstraZeneca (AstraZeneca AB and AstraZeneca plc) had appealed the judgment from the General Court of the European Union of July 2010 where the European Commission’s fine for i.a. abusing the patent system was upheld, although it was reduced to 52,5 mill EURO.

Eight years after Norway implemented the Patent Directive (Directive 98/44/EC), and four years after the Patents Act underwent some further changes when Norway acceded to the EPC, the Norwegian Ministry of Justice (MoJ) has issued a consultation paper in which some of the implemented measures are reviewed and some amendments and adjustments are proposed.

>In Norway there is a fear that the dangerous patent creature shall play with the even more dangerous biotechnology creature.

On 17th July 2012, the Norwegian Medicines Agency (NMA) announced a change in their practice regarding disclosure of information for applications of marketing authorisations for medicinal products.

The European Ombudsman has recommended that the European Medicines Agency (EMA) ensures adequate transparency in its decisions regarding the Paediatric Regulation.

It is crucial for early-stage life sciences companies to ensure that they have title to the inventions which they rely upon.

When the lover's ex-wife was admitted to the hospital where the employee worked as a health professional, the employee opened and read the journal of the lover's ex-wife.

Whilst on holiday in Norway in 2011, a German tourist was injured following a car accident with a Norwegian national.

The Ministry of Health and Care has recently issued a hearing letter proposing stringent restrictions on import of medicinal products for personal use.

On 3rd May 2012, Advocate General Verica Trstenjak issued her opinion in case C-130/11, also known as the Neurim case.

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.

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.

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.