Overview

The Application of EU Competition Law in the Pharmaceutical Sector

By Inside EU Life Sciences on July 31, 2012

Article originally published in Journal of European Competition Law & Practice Advance Access on July 31, 2012

This survey article discusses the major EU competition law developments in the pharmaceutical sector from 1 July 2011 through 30 June 2012. The developments during this period were largely incremental, but presage what…
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Belgium – Regulatory Overview

By Peter Bogaert on March 5, 2012

Posted in Food & Drug Regulatory, Medicinal Products

Article originally published in the Life Sciences Handbook, 2012

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?

Legislation
The main legislative acts regulating medicinal products are the:

Medicines Law 1964.
Royal Decree of 14 December 2006 on Medicines for Human Use and Veterinary Use.
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