The updated EMA document contains several revised Q&As on Herbal Medicinal Products (HMPs) including the Q&As regarding the requirements for the simplified registration procedure.
How can I relate my herbal tea product to EU herbal monographs on herbal tea combinations?
EU herbal monographs on tea combinations provide some flexibility for applicants. According to the agency it is possible to obtain registration for a specific combination product provided that it can be demonstrated that all requirements are met - even if such combination was not covered by a monograph (e.g. reference can be made to the established herbal tea monograph with an adequate justification).
Are HMPs which fulfil the medicinal use requirement of 30 years in a Member State which acceded recently to the EU, or in EEA EFTA States, eligible for the simplified registration procedure (or traditional-use registration)?
The required period of at least 15 years of medicinal use (which is supported by relevant bibliographical or expert evidence) of a HMP in a Member State (or on the territory of the EEA States) should be taken into account, irrespective of whether this use has taken place either fully or partially before that Member State’s accession to the EU (or irrespective of when they joined the EEA). Moreover, the medicinal use requirement of at least 30 years shall be considered met if the HMP has been in medicinal use for at least 30 years in that Member State (or in an EEA EFTA State) only.
Are medicinal products, which have been extensively used for 10 years in a Member State before its accession to the EU, or in an EEA EFTA State, eligible to demonstrate their "well-established use"?
It is possible to replace results of pre-clinical tests and clinical trials by detailed references to published scientific literature if it can be demonstrated that the active substances have been in well-established medicinal use within the Union for at least ten years. Extensive medicinal use which has taken place on the territory of a new Member State is to be considered even if it has partly or fully occurred before the accession of that State. However, the criteria to be taken into account for the demonstration of a well-established use also refer to the quantitative aspects of the use, considering the extent - to which the substance has been used in practice, - of use on a geographical basis, - to which the use of the substance has been monitored by pharmacovigilance or other methods. Thus, the presence of the medicinal product on the market in e.g. Liechtenstein only (due to the size of its population) might be unlikely to suffice on its own to demonstrate well-established use.
Can the data which formed the basis for the granting of a Swiss marketing authorization be eligible for demonstration of "well-established use"?
A Swiss marketing authorization can be effective in Liechtenstein (for example) by application of a bilateral agreement between both countries. However, the data of the Swiss marketing authorization can only be provided as supportive data for the purpose of demonstrating "well-established use" and can not replace the need to demonstrate the extensive use over 10 years. In any case, systematic and well-documented use needs to be proven, taking into account the time and the extent of use in the EU / EEA, among other criteria.