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.

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

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).

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.

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.

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

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

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.

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 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 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.

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.