Guidance on declaration of herbal medicinal products

The EU guideline on declaration of herbal medicinal products entered into force on 1 February 2008, and the review of 11 March 2010 became effective on 1 October 2010.

The 'Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products' (11 March 2010) is available on the EMA website, (see link in the factbox to the right).

The guideline applies to herbal medicinal products and is primarily relevant for natural medicinal products containing herbal substance(s) and/or herbal preparation(s) as active ingredients, as well as for traditional herbal medicinal products. It will also apply to conventional medicinal products containing herbal substances or herbal preparations as active ingredients.

Purpose and contents

As indicated by the title, the guideline provides guidance on how to declare the different types of herbal substances and herbal preparations in the finished products in section 2 of the summary of product characteristics (the SPC). The general rules applicable to section 2 of the SPCs are described in the following EU guidelines:

• A Guideline on Summary of Product Characteristics (SmPC) (human medicinal products)
• Guideline on Summary of Product Characteristics (SPC) – Pharmaceuticals (veterinary medicinal products)

and in

• The Danish Medicines Agency’s Guideline on drawing up the Danish Summary of Product Characteristics of pharmaceutical specialities for human use.(Guideline is in Danish only: 'Vejledning vedrørende udarbejdelse af produktresuméer for farmaceutiske specialiteter til human brug')

Herbal substances/herbal preparations are complex compositions of substances. Characterisation and declaration can therefore be done in many different ways, and the EU member states have previously pursued different traditions, just as the individual countries have historically taken different approaches. By having harmonised the rules within the EU, the guideline now serves as a tool, which, among other things, is used for applications submitted according to the EU registration procedures (MRP and DCP). Furthermore, the guideline will provide a better basis for comparing individual medicinal products, approved nationally and within the EU.

Annex 1 of the declaration guideline provides specific guidelines on declaration in the package leaflet and labelling for this type of medicinal products.

Implementation in Denmark for new and approved products

As the declaration guideline entered into force on 1 February 2008, its requirements must therefore be fulfilled in respect of registration applications concerning herbal medicinal products submitted from this date and onwards.

It is also desired that the guideline be implemented on herbal medicinal products that have already been approved under the national procedure. If the present, approved declaration in the SPC is incompliant with the guideline, a declaration change can be applied for as a type II variation. Alternatively, the declaration must be changed at the latest when the application for renewal of the marketing authorisation is submitted. In both cases, the company’s proposal for a revised declaration must be implemented in the company’s draft on updated SPC.