Requirements for an application for registration

Requirements for an application for registration

The following Finnish Medicines Agency  administrative regulations contain detailed requirements concerning applications for registration of Traditional herbal medicinal products and also concerning products that have already been granted an authorisation:

Applying for and maintaining a marketing authorisation and registration for a medicinal product

Labelling and package leaflet for a medicinal product

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.

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

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 04/2019, item 6.3.3).

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

Literature references and expert statements to prove that the product has been in uninterrupted medicinal use for a minimum of 30 years before the date of application, including a minimum of 15 years in the European Union.

The application should be submitted to the Finnish Medicines Agency  by post, using the address P.O.Box 55, 00301 Helsinki, or Nauvontie 4, Helsinki. The envelope should be marked: “Traditional herbal medicinal product

European commissions website

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