Is it a medicinal product?

Many products on the market are on the borderline between medicinal products and other product categories, for example food supplements, medical devices, animal feed, and cosmetic products.

A product that is a food supplement in one country may be a medicinal product in Sweden

The definition of a medicinal product may differ between countries worldwide. Even within the EU, where there is a common definition of a medicinal product, the countries can interprete the definition differently. The result is that a product that is a food supplement in for example France, may be considered a medicinal product in Sweden, and vice versa.

Aspects to consider when evaluating if a product is a medicinal product

Whether a product is a medicinal product or not is determined by an overall assessment of each individual product, involving factors such as the purpose of the product, what it contains and how it is marketed. Such an assessment of a product is conducted by the MPA only in cases that involve a formal decision, such as when a new medicinal product is approved or when the sale of an illegal medicinal product is banned. In other cases the MPA can guide generally regarding aspects to consider when evaluating if a borderline product is a medicinal product, as described below. More information is available in Swedish, for example in the guide “Läkemedel eller inte Läkemedel – en vägledning”.

What is the content of the product?

If the product contains medicinal substances or medicinal plant material, it is generally considered a medicinal product. The following are examples of tools that can be used as a help to decide if the product is a medicinal product due to content:

  • Search for medicines (swedish), where you can search among medicinal substances and medicinal plants that are included in medicinal products currently approved or registered by the Swedish MPA.
  • Guide of herbs and substances, which is a list of substances and medicinal plants on which the MPA regularly receive questions. It includes information regarding how the MPA has previously evaluated products that mainly adjoin to food supplements based on that content. 

How is the product marketed?

If the product is marketed with medicinal claims, such as preventing, relieving or treating a disease or symptom of disease, it is generally considered a medicinal product. Other aspects, such as an ingredient that has a medicinal use well known by the general public or a product name can also be regarded as a medicinal claim.
• Examples of medicinal claims:
- Relieves anxiety
- Relieves pain
- Combats eczema
- Improves healing
- Combats impotence
- Combats upset stomach
- Improves resistance to infection
- Strengthens the immune defence

What is the dosage form of the product?

Typical pharmaceutical dosage forms of medicinal products are tablets, capsules, liquids, tees etc. Products with the dosage forms of typical foods, for example chips and marmalade are generally not considered medicinal products.

Is the product a medical device?

 Just like a medicinal product, the purpose of a medical device is to for example prevent and relieve a disease or injury. Examples of medical devices are plasters, pacemakers and wheelchairs. The difference is that whereas the mode of action of a medicinal product is pharmacological, immunological or metabolic, medical devices work by other means, for example by a physical or mechanical mode of action. These products must follow the regulations of medical devices before being put on the market, for example all medical devices must bear the CE marking.

If the product is a medicinal product

If the product is a medicinal product the rules according to the Swedish medicinal legislation (2015:315) must be followed. For example, a medicinal product must be approved or registered by the MPA before it is allowed to put it on the Swedish market.

Regulations regarding the import of a medicinal product for personal use when travelling to Sweden:
Travelling with medicinal products – regulations for import and export.

Regulations regarding the import of a medicinal product for personal use by postal mail to Sweden:
Sending medicinal products – regulations for import and export.

If the product is not a medicinal product

If the product is not a medicinal product there is usually other legislation applicable to the product that needs to be taken into consideration, for example that of medical devices, food or cosmetic products.

 
 
 

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