A medicine is defined as one or more medically active substances intended to prevent, diagnose, alleviate or cure an illness. A product's area of application determines whether or not it is a medicine.
Below you will find a short definition of some of the medical terms found on our web site.
When a company releases a newly discovered medicine, it is considered an original brand product. If the medicine is approved, the company is issued a patent for the medicine. This patent will last for a certain number of years.
When the patent expires, reproduction of the original brand product is permitted. These copies are known as generic medicinal products. Generic medicinal products are neither higher nor lower in quality than the original medicinal product. They contain the same active substances.
In parallel-imports, a company specialised in the sale of medicinal products imports original brand products from other European countries where medicine prices are lower than they are in Sweden.
Companies in parallel-imports do not conduct their own research or manufacture their own medicines. They re-package existing medicinal products so that the packaging and instructions are in compliance with Swedish requirements.
In order to be sold in Sweden, the medicine must be approved by the Swedish Medical Products Agency or the European Medicines Agency, EMA.
Medicinal products with special permission
Medicinal products that have not been approved by the Swedish Medical Products Agency or the EU may still be sold to individual patients, after special permission from the Medical Products Agency, when justified by a special reason. TLV decides whether a medicinal product with special permission should be covered by the pharmaceutical benefits or not.
Orphan medicinal products
An orphan medicinal product is a medicine which is used to treat very rare illnesses. In order to be categorized as an orphan medicine product in the EU, it must be used to treat an illness which occurs in no more than 5 in every 10,000 people.
Last updated 16 juni 2020