Medicinal products are products which are intended for administration to human beings or animals in order to prevent, detect, palliate or cure disease or symptoms of disease or to be used for a similar purpose.
Certain medicinal products for external use (VUM) refer to so-called free medicinal products as defined in the Drugs Ordinance which applied earlier (1962:701).
The definition covers medicinal products for external use for the treatment of mild diseases in man or animals in which the active ingredient or ingredients have a well established medical use with a recognised effect and an acceptable safety margin. See "Medical Products Agency's guidelines on authorization to place certain medicinal products for external use on the market (LVFS 1995:19)”
VUM are medicinal products that are considered ”active against diseases or symptoms of disease which are temporary or mild, i.e. for conditions which are suitable for self-medication.”
Approved fields of application for VUM
Product types and fields of application for human use
| Type of product |
Indications |
| Ointments for wounds |
Treatment of minor, uninfected wounds, such as blisters, scratches and scrapes, small, superficial burns and mild skin irritations. Treatment of mild forms of acne and external haemorrhoids. |
| Antiseptic agents |
Treatment of minor, uninfected wounds, such as blisters, scratches and scrapes, and small, superficial burns. The treatment of mild forms of acne. Rinsing the mouth and throat when treating mild sore throats. |
| Liniments and impregnated plasters |
Local increase of the blood circulation to relieve temporary muscle pains. |
| Products for inhalation* |
Temporary irritation in the upper respiratory tract. |
| Preparations for corns |
Treatment of corns. |
| Preparations for warts |
Treatment of warts on hands, feet, knees and elbows. |
| Eye-baths |
Rinsing and bathing when treating mild eye irritation or dry eyes. |
*Also include nose drops to treat colds (containing physiological saline).
Product types and fields of application for veterinary use
| Type of product |
Indications |
| Ointments for wounds |
Treatment of minor, uninfected wounds, such as blisters, scratches and scrapes, small, superficial burns and mild skin irritations. |
| Antiseptic agents |
Treatment of minor, uninfected wounds, such as blisters, scratches and scrapes, and small, superficial burns. Rinsing the mouth and throat. |
| Liniments and impregnated plasters |
Local increase of the blood circulation to relieve temporary muscle pains. |
| Products for inhalation |
Temporary irritation in the upper respiratory tract. |
| Eye-baths |
Rinsing and bathing when treating mild eye irritation or dry eyes. |
| Cooling clays and ointments |
For the relief of temporary muscle, tendon, or joint pains. |
* Certain eye-rinsing liquids or nose drops for nasal congestion may also be considered as medical technical products if they are primarily intended for mechanical rinsing. Eyewashes may also be classified as cosmetic or hygienic products.
Application
Applications must be made according to the CTD format and the same form that is used for conventional medicinal products should also be used for medicinal products for external use. It has to be clearly indicated in the covering letter that the application is regarding an approval as a medicinal product for external use.
The application should be sent to the Medical Products Agency with the reference documentation enclosed. The application fee will be invoiced to the applicant. The application and the enclosed documentation should be in either Swedish or English.
The Medical Products Agency will assess the application with regard to quality, safety and efficacy. After an application for approval of a medicinal product for external use is received, normally a maximum of three injunctions for supplementary documentation (denials) are sent, unless special circumstances apply, before a final decision is made.
For further information regarding variations, renewals and product information, see links under Medicinal Products.