In Sweden, prescription of an unauthorised medicinal product is possible when medical conditions cannot be treated with approved drugs or if approved drugs have shown to be ineffective, and e.g. if the medicines have been approved in other EU countries.
The Medical Products Agency (MPA) can at short notice allow prescription of a drug to an individual patient by issuing a special permission (licence) on a named patient basis.
For veterinary medicinal products, permissions (licences) may be given for an individual animal or an animal species treated at a clinic.
The application procedure
A prescriber initiates the application by writing a prescription and by filling the form for justification of the prescription (available in Swedish only), and handing it to a pharmacy.
The pharmacy checks the supply and availability of the drug product and submits an electronic application to the Medical Products Agency (MPA).
The MPA makes an individual assessment of each application. Physicians or veterinarians and pharmacists at the MPA evaluate the application in accordance with current legislation. Clinical relevance and that drug products are manufactured in accordance with acceptable standards in line with pharmaceutical quality/GMP are confirmed.
The application can be granted or rejected. The pharmacy and prescriber responsible for the application will be notified of the decision.
• A named patient permission is valid for one year if nothing else is stated.
• The prescriber is responsible for informing the patient about the product.
• Adverse effects must be reported to the MPA.
• The system is restrictive. In Sweden authorised medicinal products should first and foremost be used.
• It is not permitted to promote an unauthorised drug.
• A named patient permission is available for prescribers in order to facilitate necessary treatments.
• The named patient basis procedure is regulated in LVFS 2008:1.