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What change of conditions must take place in the case of an authorised herbal medicinal product so that Section 30 paragraph becomes applicable to it?

The provisions of Section 30 paragraph 10 shall apply to herbal medicinal products

-              which had been registered as traditional herbal medicinal products based on the time of their use and insufficient clinical data and for which the marketing authorisation holder subsequently submits its own clinical data or literary data.

-              for which a WEU community monograph covering the given product has been drafted.

An application for marketing authorisation variation must be submitted in any of the above cases. The texts relevant to the product must be amended in order to comply with the requirements for texts used for medicinal products with well-established therapeutic use.