Marketing authorisation application for a herbal medicinal product - requirements

The following Finnish Medicines Agency  administrative regulations contain detailed requirements concerning applications for marketing authorisation for herbal medicinal products and concerning products that have already been granted a marketing authorisation:

‘Applying for and maintaining a marketing authorisation and registration for a medicinal product’, 3/2015

‘Labelling and package leaflet for a medicinal product’, 3/2013

These guidelines are based on the Medicines Act and Decree.

Administrative section

An administrative section, summaries or expert reports, quality documentation and the necessary publications must always be appended in full to the application.

If the product is on the market in an EU country, the marketing authorisation can also be applied for using the mutual recognition procedure. In this case, one should first contact the pharmaceutical authorities of the EU country in question, who will initiate the mutual recognition procedure (Finnish Medicines Agency  administrative regulation 3/2015, item 6.3.3).

- Application forms, CTD-forms can be found on the Commission’s website.

Quality documentation:

Documentation must contain all necessary information, including the specific properties of the herbal medicinal product in question. (For more details on this, see e.g. Directive 2003/63/EC and guidelines CPMP/QWP/2819/00: ‘Note for guidance on quality of herbal medicinal products’ and CPMP/QWP/2820/00: ‘Note for guidance on specifications: Test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products’.)

Documentation on safety and efficacy:

A report demonstrating that the active agent(s) in the product has/have been used systematically and in a documented manner as a medicinal product for a minimum of 10 years within the Community.

Regulations and guidelines concerning the data requirements of the herbal medicinal products

European com­mis­sions web­site

Dir­ect­ives, No­tice to Ap­plic­ants (NtA), etc. (EMA's webpage)