Marketing authorisations for medicinal products based on natural raw materials

Classification of the product – medicinal product or not

A product can be classified as a medicinal product based on what it contains and/or based on what the seller claims about the product. Each substance or combination of substances is, if provided with claims indicating that it has characteristics for preventing or treating disease in humans or animals, regarded as a medicinal product. These products are subject to pharmaceutical law.

There may be different classifications of products in different countries. This means, for example, that a product sold as a dietary supplement (food) in one country could be classified as a medicinal product in Sweden.

Medicines imported from other countries must be reviewed and registered or approved by the Swedish Medical Products Agency, before they are allowed to be sold on the Swedish market. An approved medicine from another EU country is therefore not automatically approved in Sweden.

It is not certain that it is legal to start selling a product, just because it is not classified as a medicinal product. The product  belongs to another product category with another regulatory framework, such as the food law. In the case of food products the Swedish Food Agency is the competent authority.

The active components of HMPs and THMPs consist of materials and preparations from plants. The difference between the different product categories lies in the efficacy documentation.
For HMPs, scientific studies must be provided, which prove that the herbal preparation has effect on the intended medical use. For THMPs, the intended medical use shall be based on traditional use of the plant material in the specific medical condition during at least 30 years, of which at least 15 years are within the EU.

In herbal remedies, the active components shall be of animal origin (such as fish oil), bacterial cultures, minerals or salts.

Anyone who wants to import a medicinal product into Sweden for sale on the Swedish market, must have the necessary information to make a proper application for marketing authorisation. Therefore, it is recommended to contact the company responsible for the product in the country where the product is already on the market, both in order to obtain information about the product and to discuss the conditions for launching the product on the Swedish market.

The Swedish Medical Products Agency recommends individuals who want to start a business with import and sale of medicinal products and who have no experience in such activities, to contact a professional consultant for guidance.
There is a trade association, Svensk Egenvård, for suppliers of herbal medicinal products, natural remedies and food supplements on the Swedish market.

Manufacturing of medicinal products

As with other medicinal products, licences are required to manufacture and import herbal medicinal products, traditional herbal medicinal products and natural remedies. A prerequisite for obtaining such a licence is that production is done according to Good Manufacturing Practice, GMP.

Manufacturing authorisations (Swedish):

Wholesale trade

Wholesale trade in medicines includes all handling of a medicinal product from the time it is released from the manufacturer until it reaches the retail level, that is, the pharmacy or other outlet where the medicinal product is sold to the customer/patient.

Anyone who deals with wholesale of medicinal products must have a wholesale authorisation.

Wholesale authorisation:

Retail trade (Swedish)

Other rules and licences apply to those who sell medicinal products directly to individual customers/patients e.g. pharmacies or other retail stores.

Retail trade with non-prescription medicines (Swedish):

A common misconception is that a medicinal product approved in another EU country is automatically approved in Sweden and vice versa. This is not the case, but EU rules can make it easier to apply for authorisations in several EU countries.

There are different authorisation procedures, e.g. the national procedure which may render a marketing authorisation in Sweden only. In order to get a marketing authorisation for a herbal medicinal product in several EU countries, the decentralised procedure (DCP) or the mutual recognition procedure (MRP) are possible alternatives.

The application is based on a so-called dossier, which consists of five different modules:

1. Administrative information
2. Expert reports and summaries of the documentation in modules 3–5
3. Quality documentation
4. Safety documentation (non-clinical studies and information)
5. Efficacy documentation (clinical studies and information)

Modules 2–5 has a format called common technical document (CTD) and is uniform for the EU, the US and Japan. The format of the first module may vary depending on country-specific requirements, but it is the same within the EU.

All categories of medicinal products have the same requirements for the information in module 3, but the scope and volume of the documentation in module 2, 4 and 5 may vary. The application for a marketing authorisation may be a so-called full application. Such an application shall contain full information in all modules, which means that not only quality, but also safety and efficacy, is corroborated with data from product-specific studies. Full application is used for completely new products, such as products containing new synthetic substances or ingredients that have not appeared on the European market before.

Under certain conditions less extensive documentation in modules 4 and 5 can be accepted, and a so-called simplified application can be submitted. In these cases, product-specific data regarding safety and efficacy can be replaced, to a varying degree, by documentation proving that the product has a well-established medical use or traditional medical use.

When the Swedish Medical Products Agency receives an authorisation application and the application fee is paid, a project group responsible for processing the application is formed. The group consists of assessors with different competencies. The Swedish Medical Products Agency assesses whether the requirements on medicinal product manufacture, quality and safety are met. With the exception of certain product categories, an assessment is also made whether the effect of the drug is satisfactorily documented and whether it is commensurate with known side effects.

In most cases, the Swedish Medical Products Agency requests additional documentation from the applicant, for example if the application is not complete or questions arise during the assessment.

The Swedish Medical Products Agency´s assessment time should not exceed 210 days. Those days when the authority awaits completions from the applicant, are not included in the time frame.

There are rules governing where different product categories of medicines can be sold. According to the law, natural remedies and traditional herbal medicinal products may be sold in outlets other than pharmacies in Sweden, e.g. the products may be sold both in pharmacies and in retail trade. Online sales are also allowed within Sweden.

Other herbal medicinal products, which are not classified as traditional, may be sold in the same outlets as other "ordinary" medicinal products. The main rule, then, is that they can only be sold in pharmacies.

However, some non-prescription herbal medicinal products are on the list of “Non-prescription medicinal products allowed for sale at outlets other than pharmacies” and may thus be sold in retail trade.

HMPs that may be sold in retail trade (Swedish):

The marketing authorisation holder is responsible for the medicinal product as long as the product is on the market, that is, until it is deregistered. The responsibility includes, for example:

• manufacture inspections
• monitoring the safety of the product, known as pharmacovigilance
• updates to the product documentation (dossier), for example as a result of changes in the manufacturing process
• updates of the product information (summary of product characteristics, package leaflet and labelling text), for example as a result of new safety data

Change, renewal and sunset clause
If the dossier and/or product information of the medicinal product needs to be changed, a change notification (minor issues) or a variation application must be sent to the Swedish Medical Products Agency.

Variation application (Swedish):

Five years after a medicinal product has received a marketing authorisation, the authorisation must be re-evaluated and renewed. The marketing authorisation holder of the product is responsible for submitting the application for renewal to the Swedish Medical Products Agency on time.

Renewal application (Swedish):

If a medicinal product is not released on the Swedish market within three years of the marketing authorisation being granted, the Swedish Medical Products Agency shall decide that the approval shall no longer apply. This is called "sunset clause".

Sunset clause (Swedish):

Rules for marketing/advertising
According to the Medicines Act, marketing must be adequate, objective and balanced. The content of the advertisement must not result in inappropriate use or people avoiding seeking relevant care. For traditional herbal medicines, it must be stated that the product is a registered traditional herbal medicinal product and that the registration is based solely on experience of long-term use.

Marketing of medicinal products for human use (Swedish):