CRED NPM

05/11/2024

Internal Considerations on regulatory application, claims and brandname

Grouping of 3 variations (national procedure) :

• Type II/C.I.z : Change in the classification for the supply for Nationally Authorized Products.

• Type IA/B.II.e.5.b : Deletion of pack sizes (to keep only a 7 film-coated tablets packaging, mandatory for an OTC use in FR)

• Type IB/A.2.b) : Change in the (invented) name of the medicinal product for Nationally Authorized Products.

Challenge on Labelling & claims

Challenge on brandname

• Negotiating with ANSM about FR labelling to obtain the best reflection of the safety/efficacy profile • Labelling = first source of claims

• Rejection of the global brand Allegra • Approval of

The Organisation for Professionals in Regulatory Affairs

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Internal Health education, promo & patient empowerment

The Organisation for Professionals in Regulatory Affairs

16

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