INTUITY intervenes on every issue related to pharmaceutical law and healthcare products or borderline products: medicinal products, medical devices, dietary supplements, cosmetics, biocides…
The Firm assists its clients in the procedures for obtaining national or community marketing authorizations, or authorizations specific to pharmaceutical establishments.
From upstream to downstream, from clinical research to price setting and conditions for reimbursement, INTUITY closely supports its clients in every legal/regulatory step imposed by national or community authorities in compliance with the strategy set and previously requested (procedures for obtaining marketing authorizations, specific authorization to pharmaceutical establishments, management of personal data and patient follow-ups, advertising development).
INTUITY suggests, specifies, drafts, negotiates and accompanies its clients along every contractual framework step, and coordinates legal strategies for their implementation and their defense before any arbitration, civil and administrative body.
Christophe Hénin :
RECENT WORK :
Support to a manufacturer of dietary supplements towards healthcare authorities of some Union member States
- Healthcare authorities of some European Union member States challenged the classification of dietary supplement manufactured by one of the Firm’s client. These Authorities deemed that the said product was to be classified as a medicinal product at least by presentation. INTUITY assisted this client before these authorities by putting forward arguments to justify that the product concerned could not be classified as medicinal product by presentation, but completely meets the definition of a “dietary supplement”.
Advice to an innovative pharmaceutical company in a litigation proceeding on data protection
- The Firm assisted an innovative pharmaceutical company of international dimension in the steps vis-à-vis the competent authorities for marketing authorization applied by a competitor for a fixed combination of active substances. This application was infringing the period for data protection the pharmaceutical benefits for one of its key specialty. INTUITY developed a line of reasoning challenging this authorization granting, and initiated contact with the French representative at European Medicines Agency so as to defend this opinion. The procedure was therefore suspended and the question raised by the pharmaceutical company was submitted to the European Commission.