Application for marketing authorisation of herbal medicinal products and natural medicinal products

Application format and documentation

Applications must be in the CTD format and the same application forms as for conventional medicinal products should be used. A guideline on the use of the CTD format for herbal medicinal products can be found on the EMA website. On the EMA website you can also find regulatory and scientific guidelines specifically covering herbal medicinal products. Guideline on the use of the CTD format.

Guideline on the use of the CTD format for THMPs

Scientific guidelines for Herbal medicinal products – EMA

Notice to Applicants, the European Commission's compilation of guidelines for applicants

In short, the application is a dossier consisting of five modules:

1. Administrative information (including product information)
2. Expert reports and resume of documentation in modules 3‍-‍5
3. Quality documentation
4. Non-clinical documentation (pre-clinical studies and information)
5. Clinical documentation (clinical trials and information)

Documental requirements to confirm efficacy and safety (module 4 and 5) vary depending on product category and type of application. Read more about this on the page about Efficacy and Safety (module 4 and 5).

The quality requirements for these product categories are the same as for conventional medicines, that is, a full copy of the quality documentation must be submitted in the application for authorisation / registration. However, in addition to the quality guidelines that apply to medicinal products in general, there are additional requirements that apply specifically to herbal medicines.

Procedures for application

The same principles for procedures as for conventional medicinal products apply, but there are some exceptions:

• Natural medicinal products may only apply through the national procedure and marketing is restricted to Sweden
• For herbal medicinal products approved after a full application on marketing authorisation for medicinal products, or as required for drugs with well established medicinal use, the regulatory framework for the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP) is applicable (in addition to the national procedure).
• For traditional herbal medicinal products, the national procedure is always applicable but the DCP and MRP can only be used if there is an adopted union monograph on the herbal substance or if the herbal substance has been published as an entry on the commission list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.

Veterinary use

For herbal medicinal products, it is possible to apply for approval for use in animals. However, this is not possible for natural medicinal products or traditional herbal medicinal products which can only be authorised for human use.

Herbal medicinal products for veterinary use are covered by Regulation (EU) 2019/6 and provisions issued by the Swedish MPA.

Variations

All changes/modifications to an approved or registered product must be preceded by a variation application, or in some cases a notification, and approved by the Swedish MPA.

Examples include change of:

• manufacturers and suppliers
• indication
• package leaflet
• dimensions
• strength
• summary of product characteristics
• packaging
• labelling.

Provisions

The Swedish Medical Products Agency’s provisions on traditional herbal medicinal products for human use (in Swedish):

The Swedish Medical Products Agency’s provisions on marketing authorisation for medicinal products (in Swedish):

Regulations

Medicinal Products Act

Directive 2001/83/EC relating to medicinal products for human use

Regulation (EU) 2019/6 relating to veterinary medicinal products