ePrivacy and GPDR Cookie Consent by TermsFeed Generator

What change of conditions must take place in the case of an authorised herbal medicinal product so that Section 30 paragraph 9 becomes applicable to it?

The provisions of Section 30 paragraph 9 shall be applied to medicinal products

-              which had been authorised based on literary data as products with well-established therapeutic use, however, the clinical data were subsequently questioned or negative clinical trials were published which deny the declared therapeutic use, provided that the product meets the conditions stated in 1 and 2 of Section 30,

-              which are covered by a traditional Community monograph.

In any of the above-stated cases it is necessary to apply for a marketing authorisation variation. Texts relevant to the given product must be amended in order to comply with the requirements for traditional herbal medicinal products.