New Policy in the Pharmaceutical Industry: First Assessment and Trends

Key points

Since the adoption of an action plan by the Council of Ministers on 12 July
2020, an overhaul of the regulatory framework has been launched, resulting
in the publication by the Ministry of the Pharmaceutical Industry of more
than 40 regulatory texts, which have a deep impact on the activities of
importing, manufacturing, distributing and registering pharmaceutical
products.

An initial assessment of this new policy can be summarised as follows:
• A saving of nearly 800 million euros on imports by 2021.
• Manufacturer status now available to establishments outsourcing their
production.
• An obligation to designate an “operator” when the marketing
authorisation is held by an entity in the country of origin.
• The promotion of exports through the granting of several advantages,
including the exemption from the 49/51% rule.
• The introduction of several control mechanisms aimed at ensuring a
healthy and transparent functioning of the market, and detecting cases
of over-invoicing.

For more information, the full version of this newsletter is available here.