Frequently Asked Questions

On this page you will find frequently asked questions and answers about herbal medicinal products, traditional herbal medicinal products and natural remedies.

1. Do all medicinal products have to be authorised/registered before marketing? Even imported ones?

2. What determines whether a product is classified as a medicinal product?

3. What is the difference between herbal medicinal products, traditional herbal medicinal products and natural remedies?

4. What is the process for an application for marketing authorisation?

5. How should the documentation in the application be compiled?

6. Are product specific data always required for an authorisation/registration of a medicinal product?

7. Does the application for marketing authorisation apply in one member state or in several member states within the EU?

8. What happens when the application for marketing authorisation is submitted to the Swedish Medical Products Agency?

9. What happens when the marketing authorisation has been granted?

10. Which rules apply for marketing of herbal medicinal products, traditional herbal medicinal products and natural remedies?

11. Is a license required for manufacturing, import and trading of medicinal products?

12. Where may natural remedies, traditional herbal medicinal products and herbal medicinal products be sold?

13. Which herbal remedies are approved by the Swedish Medicinal Products Agency

14. Is a Nordic packaging (Nordic mock-up cooperation) possible for medicines registered through a national procedure in one country and registered through a decentralised procedure in another country, if the product and all product information are the same?

15. Is it possible to have different names for the same product in different countries even if the drug is approved by a decentralised procedure?

16. Can herbal medicines be labelled as organic?

17. Must the information in the Summary of Product Characteristics (SmPC) be the same in all countries for a drug approved by a decentralised procedure?

 

1. Do all medicinal products have to be authorised/registered before marketing? Even imported ones?

Yes. Medicinal products may be sold in Sweden only after their authorisation/registration by the Swedish Medical Products Agency. This also applies to medicinal products imported from other EU countries, USA and other parts of the world, no matter how well known the products are in their original countries. An authorised medicinal product from another EU country is not automatically authorised in Sweden. Classification of medicinal products may also differ between different countries; a product may be sold as a food supplement in one country, but classified as medicinal product in Sweden.
Read more on classification in question 2.
Read more on how to apply for marketing authorisation in question 4.

2. What determines whether a product is classified as a medicinal product?

According to the Swedish Medicinal Products Act (2015:315) a medicinal product is any substance or combination of substances presented as having properties for preventing or treating diseases in human beings or animals. Marketing authorisation issued by the Swedish Medical Products Agency is required for medicinal products.
Classification may be a simple question, for example all synthetic compounds to be used for specific diseases are considered to be medicinal products. Other cases are more difficult, for example products based on naturally occurring raw material. The legislation for medicinal products also covers homeopathic medicinal products, herbal medicinal products, traditional herbal medicinal products and natural remedies. These medicinal products may contain ingredients that are also present in food products, medical devices and cosmetic products. The Swedish Medical Products Agency supervises the compliance to the legislation for medicinal products, and determines whether a product is a medicinal product or not. If a product is not considered to be a medicinal product, another legislation – such as the food legislation - is applicable and must be followed before the product is put on the market. The National Food Agency is the competent authority responsible for the supervision of food products in Sweden.


3. What is the difference between herbal medicinal products, traditional herbal medicinal products and natural remedies?

The active constituents in herbal medicinal products and traditional herbal medicinal products are plant materials/preparations. The difference between these two product categories is the documentation on efficacy. For herbal medicinal products scientific studies, proving efficacy for the relevant indication, are required. For traditional herbal medicinal products the efficacy should be assessed as reasonable and the indication should be based only on traditional use of the herbal substance for at least 30 years (including at least 15 years of use within the EU).
In many products the active components have been concentrated to extracts through the use of solvents. Medicinal products may contain product specific extracts, which means that two products, although based on the same herbal substance, may contain different extracts of different strengths, and may belong to different product categories and have different uses.
The active components of natural remedies are of animal origin (for example fish oil), bacterial cultures, minerals and salts. The requirements on efficacy documentation are the same as for herbal medicinal products, i.e. efficacy for the relevant indication must be proved by scientific studies.

4. What is the process for an application for marketing authorisation?

Applying for marketing authorisation is a demanding work. The legal framework for products that will be used to affect human or animal health is extensive. Good knowledge about the legislation is important before applying. For medicinal products that are intended to be imported to/introduced on the Swedish market, the person who wants to sell the product must have all the information required to make a proper application. Before starting the application procedure, it is therefore necessary to contact the company responsible for the product to discuss the conditions to market the product in Sweden.
The procedure is summarized in the following steps:

  1. Clarify which legislation is applicable to the product
    See question 2 regarding classification and question 3 for different product categories containing natural products.
  2. Make sure that appropriate licenses/certificates are available
    See question 11 regarding licenses for manufacturing and distributing medicinal products
  3. Compile the documentation for the application (dossier) to the competent authority
    See question 5 and question 6 on how the application should be compiled
  4. Clarify which application procedure to use
    Within EU there are various ways to get a medicinal product authorised in a member state or in several member states at the same time. Read more about application procedures in question 7.
  5. Assessment of application by the competent authority
    When the application has been sent to a competent authority the assessment begins. Read more about the assessment in question 8.
  6. Decision on authorisation/registration
    When the competent authority approves the application for marketing authorisation the product may be put on the market and sold in the/those member states that have granted the application.
    Read more on what happens after decision on authorisation and registration in question 9. Read more on marketing in question 10. Read more on permit for wholesale and retail in question 11 and question 12.

The Swedish Medical Products Agency recommends individuals who lack former experience but want to start importing and marketing medicinal products, to contact consultants for guidance in the registration/authorisation process.
There is a trade association, Svensk Egenvård (Swedish self-care), for providers of herbal medicinal products, natural remedies, food supplements and natural skincare products on the Swedish market.

5. How should the documentation in the application be compiled?

The application is based on a so-called dossier that consists of five different modules:
1. Administrative information
2. Expert reports and summaries on the documentation in modules 3-5
3. Quality documentation
4. Non-clinical study reports (documentation on safety)
5. Clinical study reports (documentation on efficacy)

Module 2-5 has a format called Common Technical Document (CTD) and is consistent across the EU, USA and Japan. The format of the first module may vary between different national medicines agencies but is uniform within the EU.
Read more about CTD for Herbal Medicinal Products here.
The requirements on the information in module 3 are the same for all categories of medicinal products, but the extent of documentation in module 2, 4 and 5 may vary between different types of medicinal products. The conditions for different groups of medicinal products are defined in EU-directives that have been incorporated into Swedish legislation. The basic model for the application for marketing authorisation is a so-called complete application, or an application in accordance with Chapter 3 in the Swedish Medical Products Agency’s provisions (LVFS 2006:11) on authorisation of medicinal products. Such an application must contain complete information in all modules and is used for completely new products such as new synthetic compounds or ingredients that have not previously been on the European market. Under certain conditions a reduced amount of documentation in module 4 and 5 may be accepted, and a so-called simplified application can be submitted. Read more about simplified application in question 6.

6. Are product specific data always required for an authorisation/registration of a medicinal product?

The quality documentation must be product specific. Under certain conditions a reduced amount of product specific preclinical (for example animal studies) and clinical (studies on humans) documentation may be accepted. In these cases a so-called simplified application may be submitted.
Read more about well-established use and traditional use.

7. Does the application for marketing authorisation apply in one member state or in several member states within the EU?

A common misunderstanding is that when a medicinal product is authorised in one member state within the EU, it is automatically authorised in Sweden and vice versa. This is not correct. However, the EU regulations can make it easier for companies to apply for registrations/authorisations in several EU member states.
A national authorisation is only valid in that particular member state. To apply in several member states the decentralised procedure (DCP) or mutual recognition procedure (MRP) may be relevant for herbal medicinal products.
Read more about the authorisation procedure here.

8. What happens when the application for marketing authorisation is submitted to the Swedish Medical Products Agency?

When an application is received by the Swedish Medical Products Agency, and the application fee is payed, a project team will be responsible for assessing the application. The team is comprised of assessors with different areas of expertise who evaluate the different modules. The Medical Products Agency will assess whether  the requirements concerning the manufacturing, quality and safety of the product are fulfilled, for example that the manufacturing is in accordance with applicable legal requirements, the contents of each divided dose is reproducible, stability is guaranteed and the safety of the product is good. Also, for medicinal products that are to be authorised (not registered), the efficacy has to be satisfactorily documented and proportional in relation to any known side effects.
The application is processed in several steps, and requests for supplementary information may be sent to the applicant on several occasions if questions arise or the application is deemed incomplete. The Medical Products Agency strives not to exceed a processing time of 210 days. This time excludes the days when the Swedish Medical Products Agency awaits additional information from the applicant.

9. What happens when the marketing authorisation has been granted?

It is important to know that the marketing authorisation holder is responsible for the medicinal product as long as the product is on the market, i.e. until the product is withdrawn. This responsibility includes for example inspections of the manufacture and to monitor the safety of the product, which is called pharmacovigilance (post marketing surveillance such as collection and evaluation of adverse events, signal detection, periodic safety update reports and actions in response to safety concerns).
Changes/variations to an authorised or registered product are regulated by EC regulation 1234/2008. Variations can for example concern the indication of the medicinal product, its content, strength or formulation. The regulation also applies for changes to the product information, such as the labelling and the package leaflet.
Read more about variations here.
An application for renewal of the marketing authorisation has to be submitted five years after the first authorisation.
Read more about renewals here.
If an authorised product is not placed on the Swedish market within three years of its granting, the Swedish Medical Products Agency will decide that the authorisation is no longer valid. This is called the “sunset clause”. Read more about Sunset clause here.

10. Which rules apply for marketing of herbal medicinal products, traditional herbal medicinal products and natural remedies?

According to the Medicinal Products Act (2015:315) marketing shall be up-to-date, objective and balanced. The content of advertisement must not lead to inappropriate use or make people refrain from seeking appropriate care.
For traditional herbal medicinal products it must be stated that the product is a registered, traditional herbal medicinal product used in specific indication(s) exclusively based upon long-standing use.

11. Is a license required for manufacturing, import and trading of medicinal products?

As for other medicinal products, a license is required to manufacture or import authorised natural remedies, herbal medicinal products and registered traditional herbal medicinal products.
Different rules apply for wholesale trade (no sales to individual consumers) and retail (sales to individual consumers).
Authorised natural remedies and registered traditional herbal medicinal products may be sold “freely” in retail trade. These medicinal products are not covered by the regulations on trade of certain non-prescription medicinal products, and are thus not included in the list of non-prescription medicinal products that may be sold outside pharmacies.

12. Where may natural remedies, traditional herbal medicinal products and herbal medicinal products be sold?


According to the Act (2009:366) on commerce of medicinal products, natural remedies may be sold by other actors than pharmacies in Sweden and can therefore be sold by both pharmacies and other retail. Also web based sales are allowed (within Sweden). The same rules apply for traditional herbal medicinal products.
Herbal medicinal products may be sold as other medicinal products. The general rule is that they can be sold in pharmacies only. Certain non-prescription herbal medicinal products may also be sold by retail other than pharmacies, in the same way as some other non-prescription medicinal products.

13. Which herbal remedies are approved by the Swedish Medicinal Products Agency


You may find lists of authorised natural remedies, registered traditional herbal medicines and authorised herbal medicines by using the provided links.

 Authorised Natural Remedies

 Registered Traditional Herbal Medicinal Products

 Authorised Herbal Medicinal Products

 

14. Is a Nordic packaging (Nordic mock-up cooperation) possible for medicines registered through a national procedure in one country and registered through a decentralised procedure in another country, if the product and all product information are the same?

Yes, as long as the information is the same in both languages, it is not a problem.

More information on nordic mock-up cooperation

15. Is it possible to have different names for the same product in different countries even if the drug is approved by a decentralised procedure?

Yes. The product name is a national decision, regardless of whether the drug has been approved by national or decentralised procedure. The product name can be changed separately in one of the countries included in the decentralised procedure. However, the drug must have the same name in the countries that have a single package (Nordic mock-up cooperation).

16. Can herbal medicines be labelled as organic?

No. The outer package or package leaflet may contain symbols or imagery that are intended to clarify certain information about the medicine and benefit the patient, provided that it does not have a commercial character.
Organic labelling is not considered to be health information and may not be added.

17. Must the information in the Summary of Product Characteristics (SmPC) be the same in all countries for a drug approved by a decentralised procedure?

Yes, the Summary of Product Characteristics is the same in all countries that have been in the same decentralised procedure.

 
 
 

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