In August 2021, the European Medicines Agency-EMA published an update of the regulatory Question & Answer document on Herbal Medicinal Products. Altogether, there are 15 questions ranging from eligibility for marketing authorization of traditional use to questions about the percentage limit of excipients in herbal teas.

Check below the 15 questions included in the new version of the document published by the EMA:

• (R1) Are there any limitations in the number/percentage of excipients in herbal teas?

• (R2) Are medicinal products containing D-camphor, levomenthol, 1,8-cineol, thymol or rutoside as active substances eligible for traditional use registration?

• (R3) Are the medicinal products containing propolis eligible for traditional-use registration?

• (R4) What dosages of vitamins and minerals are acceptable in traditional herbal medicinal products eligible for simplified registration?

• (R5) Is reference to “organic farming” acceptable in either the labelling or in the package leaflet of a herbal medicinal product?

• (R6) What kinds of safety data are required for applications according to Article 16a of Directive 2001/83/EC in case of Ayurvedic preparations?

• (R7) How can I relate my product to a EU herbal monograph where herbal preparations are listed and have ‘well established medicinal use’ indications?

• (R8) How can I relate my product to an EU herbal monograph where herbal preparations are listed with ‘traditional medicinal use’ indications?

• (R9) How can I relate my herbal tea product to EU herbal monographs on herbal tea combinations?

• (R10) Are herbal medicinal products which fulfil the medicinal use requirement of 30 years in a Member State which acceded recently to the EU eligible for the simplified registration procedure (or traditional-use registration)?

• (R11) Are herbal medicinal products with medicinal use in Iceland, Liechtenstein and Norway (i.e. EEA EFTA States) throughout a period of at least 30 years eligible for the simplified registration procedure?

• (R12) Are medicinal products, which have been extensively used for 10 years in a Member State before its accession to the EU, eligible to demonstrate their “well-established use” according to Article 10a of Directive 2001/83/EC?

• (R13) Are medicinal products, which have been extensively used for 10 years in an EEA EFTA State eligible for demonstration of well-established use according to Article 10a of Directive 2001/83/EC?

• (R14) Can the data which formed the basis for the granting of a Swiss marketing authorisation be eligible for demonstration of well-established use according to Article 10a of Directive 2001/83/EC?

• (R15) Is a European Union monograph equivalent to a summary of product characteristics (SmPC)?

Access the full update of the document Regulatory Questions and Answers for Herbal Medicinal Products: https://bit.ly/3CAxZGS

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