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EU legal and regulatory update APRIL 2023.
- Source :
-
Journal of Generic Medicines . Jun2023, Vol. 19 Issue 2, p105-113. 9p. - Publication Year :
- 2023
-
Abstract
- Kwizda Pharma markets four products in respect of which it states that their ingredients prevent bacteria from adhering to the mucous membranes of the urinary tract, so that the consumption of those products is recommended in the event of urinary tract infections ("the products in question"). I Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. i This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. The referring court also questions the distinction between the concept of "food for special medical purposes" and that of "medicinal product" and "food supplement". Therefore, by deciding that the Commission also had to check the existence of a therapeutical contribution in the first medicine and of its absence in the second and to examine how this was working in the first medicine and how this had been examined by the CHMP and by the national authority which granted a marketing authorization, the General court did not correctly apply the regulatory framework. [Extracted from the article]
Details
- Language :
- English
- ISSN :
- 17411343
- Volume :
- 19
- Issue :
- 2
- Database :
- Academic Search Index
- Journal :
- Journal of Generic Medicines
- Publication Type :
- Academic Journal
- Accession number :
- 164355857
- Full Text :
- https://doi.org/10.1177/17411343231172777