Plants and their different extracts have been used in traditional medicine throughout history, demonstrating their effects empirically in everyday use. That is why there are specific simplified registries for this type of herbal medicines.
In the case of the European Union, Traditional Herbal Medicines have a simplified authorization process included in Directive 2001/83 / EC (and its transpositions in the different Member States) through which we can put our product on the market with fewer requirements as far as the demonstration of the effectiveness is concerned, which implies lower costs and times.
The requirement to request the authorization of these drugs in this way is that there is a long tradition of use in the European Union (at least 30 years), in which the demonstration of their effectiveness also falls. This tradition must be demonstrated with bibliographic information from reliable and official sources (databases, pharmacopoeia). It is also possible to demonstrate this efficacy using as a base another traditional medicine whose composition is equivalent.
The evaluation of this request will be carried out by the corresponding Member State, which will subsequently issue a recommendation.
Applicants can choose between two forms of marketing authorization for a medicine: a national marketing authorization and a European marketing authorization. Decentralized and mutual recognition procedures can only be completed when there is a community monograph on that plant or when the medicine consists of plant substances, herbal preparations or combinations thereof that are on the list drawn up by the specific committee on the EMA.
The Bionok team has specialized professionals in the area who will guide you through the entire authorization process of your medication. We will help you create the dossier to make the request to the competent authority that you want or that can manage the authorization more quickly.
Bionok can also help you to generate the necessary toxicological reports and to carry out the pertinent bibliographic studies that allow to demonstrate the safety and efficacy of the product over time.
Do not hesitate to contact us for a non-binding estimate.
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