Pharmaceutical antitrust—Norway—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharmaceutical antitrust—Norway—Q&A guide
  • 1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?
  • 2. Which authorities are entrusted with enforcing these rules?
  • 3. Are drug prices subject to regulatory control?
  • 4. Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?
  • 5. Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?
  • 6. What are the main competition law provisions and which authorities are responsible for enforcing them?
  • 7. What actions can competition authorities take to tackle anticompetitive conduct or agreements in the pharmaceutical sector and what remedies can they impose?
  • 8. Can remedies be sought through private enforcement by a party that claims to have suffered harm from anticompetitive conduct or agreements implemented by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?
  • 9. Can the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?
  • More...

Pharmaceutical antitrust—Norway—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to pharmaceutical antitrust in Norway published as part of the Lexology Getting the Deal Through series by Law Business Research (published: April 2020).

Authors: Advokatfirmaet Thommessen AS—Eivind J Vesterkjær; Mari Gjefsen

1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?

The authorisation, pricing and marketing of pharmaceutical products in Norway are governed by the Medicinal Products Act (Act 132 of 4 December 1992), along with a set of regulations, including the Medicinal Products Regulation (Regulation 1839 of 18 December 2009). The Medicinal Products Regulation provides detailed rules regarding marketing authorisation and the pricing of pharmaceutical products.

The Medicinal Products Act and the Medicinal Products Regulation are intended to implement the EU Medicines Directive (2001/83/EC) and the EU Transparency Directive (89/105/EEC), which form part of the EEA Agreement.

2. Which authorities are entrusted with enforcing these rules?

The day-to-day enforcement of the Medicinal Products Act, the Medicinal Products Regulation and other legislation relating to pharmaceutical products is entrusted to the Norwegian Medicines Agency (NoMA). The Ministry of Health and Care Services has administrative responsibility for this area at the government level and is the appeals body for NoMA decisions.The day-to-day enforcement of the Medicinal Products Act, the Medicinal Products Regulation and other legislation relating to pharmaceutical products is entrusted to the

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