Legal framework, New applications and Variations

Herbal medicinal products and natural remedies may be marketed only after their approval by the MPA. Traditional herbal medicinal products may be sold only after they have been registered by the MPA.

Described on this page are details specific for these product categories. For general information on applications, renewals and variations, see the corresponding pages for conventional medicinal products.

Herbal medicinal products and traditional herbal medicinal products

Herbal medicinal products may be sold only after their approval by the MPA. Herbal medicinal products for human use, which do not qualify to be approved as medicinal products (in terms of efficacy and safety documentation), and which do not qualify as homeopathic medicinal products, can on application be registered as traditional herbal medicinal products. Traditional herbal medicinal products may be sold only after they have been registered by the MPA.

Current legal framework

Herbal medicinal products are covered by Directive 2001/83/EC which to a large extent is incorporated into the Medicinal Products Act (2015:315) and in provisions issued by the MPA. The MPA has issued provisions on for example, traditional herbal medicinal products for human use (LVFS 2006:3). Links to these can be found in the right pane menu and under "Legislation" to the left.

Natural Remedies

A natural remedy may be sold only after it is approved by the MPA. The MPA has published a guideline to provisions (LVFS 2006:11) on marketing authorisation for medicinal products, with focus on natural remedies (see right pane menu). Several provisions in the pharmaceutical field also apply for natural remedies. These can be found under "Legislation" to the left.

Application

Applications must be in the CTD format and the same application forms as for conventional medicinal products should be used. Links to a guideline on the CTD format and Notice to Applicants (The Commission's compilation of guidelines for applicants) can be found to the right.

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

1. Administrative information
2. Expert reports and resume of documentation in modules 3-5
3. Quality documentation
4. Pre-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.

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.

Read more about documental requirements and related guidelines in the left pane menu. Also, read practical guidance for submissions

Procedures for application

National Procedure

An approval issued in the national procedure applies only to the individual country.
Natural remedies may only apply through the national procedure and marketing is restricted to Sweden.

Decentralised Procedure and the Mutual Recognition Procedure

For herbal medicinal products approved after a full application pursuant to Chapter 3 of the MPA’s provisions (LVFS 2006:11) on marketing authorisation for medicinal products (Art. 8 Directive 2001/83/EC), or as required for drugs with well established medicinal use in Chapter 5 Section 6 and 7 of LVFS 2006:11 (Article 10a of Directive 2001/83/EC), the regulatory framework for the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP) is applicable. For traditional herbal medicinal products, 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.

Variations

All changes/modifications to an approved or registered product, such as change of manufacturers and suppliers, indication, package insert leaflet (PIL), strength, summary of product characteristics (SmPC), packaging and labelling must be preceded by a variation application, or in some cases a notification, and  approved by the MPA.

Veterinary use


For both herbal medicinal products and natural remedies, it is possible to apply for approval for use in animals. However, this is not possible for traditional herbal medicinal products which can only be authorised for human use.
Herbal medicinal products for veterinary use are covered by Directive 2001/82/EC, which to a large extent is implemented into Swedish law by the Medicinal Products Act (2015:315) and provisions issued by the MPA.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information