There are many reasons why a company may not be able to deliver certain medicines: there may be problems in manufacturing, shortage of an active ingredient, or the demand may unexpectedly skyrocket. A company can also decide to no longer sell a particular medicine on the Swedish market, and thus de-register it. When shortages occur, there are several different directions we can take to find a suitable solution for patients.
When prescribing medicine, it is always a good idea to check whether it has been marked as being back-ordered on fass.se or if it is listed on the Swedish Medical Products Agency’s compendium of back-ordered medicines. This list by the Swedish Medical Products Agency proposes advice (among other information) regarding back-ordered medicines and it is published alongside information from pharmaceutical companies. Such information includes when the medicine was first categorized as being back-ordered, how long the back-order is expected to last, and suggestions of equivalent alternatives (if available). The pharmacy can also provide information regarding their stock and which medicines can still be ordered. The FASS website has an inventory status function that lets you search which pharmacies have certain medicines in stock.
Unlicensed medicines— how it works
Unlicensed medicines are pharmaceuticals that are licensed and commercially available in other countries but not licensed in the Swedish market. The Swedish Medical Products Agency (Läkemedelsverket) grants special permissions for two kinds of sales, to an individual patient or for an entire clinic. Unlicensed medicines for individual patients are usually subsidized and can be covered by the high-cost threshold, following a decision by the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och Läkemedelsförmånsverket).
A prescribing physician or veterinarian may choose to prescribe a medicine that has been approved and licensed in another country — the medicine may have been approved or licensed in Germany or the United States, for example, but is not commercially available in Sweden. This can occur in a variety of scenarios: when a local approved product goes on shortage , gets de-registered or if the patient is not responding to their current treatments and approved Swedish medicines are not sufficient enough to fulfill the treatment plan and improve the patient’s health.
In order for a pharmacy to sell unlicensed medicine to end patients, a sales permit is required. This ensures that unapproved medicines are not dispensed from pharmacies until the Swedish Medical Products Agency has granted the requisite permission for its dispensary.
A licence motivation and application is created through a system known as Communication Solution for Licence Applications (hereafter referred to as KLAS for its Swedish acronym, Kommunikationslösning för licensansökan). The doctor selects a pharmacy operator who, in turn, applies for a permit from the Swedish Medical Products Agency. If this licence is granted, the patient is then permitted to obtain the unlicensed medicine at their pharmacy of choice. More information on unlicensed medicines can be found on the website for the Swedish Medical Products Agency (opens in a new window).
For you as a prescriber
Only licensed doctors, dentists or veterinarians can create a justification for prescription of the foreign pharmaceuticals. Once you have created a justification in KLAS, it is sent to the pharmacy; the pharmacy creates and submits a sale’s permit application with the Swedish Medical Products Agency who then handles the case. Most cases are typically handled within seven business days; the pharmacy will be notified of the decision via electronic message. You as a prescriber will only be notified by letter if:
- The justification is rejected
- Supplementary documentation has been requested
- Special information needs to be communicated directly to you
- The sale’s and dispensing permit is granted but subject to certain conditions
Unlicensed Medicines — TLV
On April 1, 2017, new laws and regulations came into force regarding the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket, also referred to as TLV). The new legislation gives the TLV the opportunity to decide on temporary subsidies for medicines that previously were sold as unlicensed medicines as well as for some medicines that are meant to replace unlicensed medicines.
The TLV is now the governmental agency that makes all decisions about which medicines and consumables can be covered by the high-cost threshold. In short, the TLV is the authority that makes decisions concerning unlicensed medicines according to a patient’s medical needs without necessarily approving those medicines for the Swedish market as a whole.
Patients and Customers
Already a customer? If so, you’ve probably noticed that you can access “Your account” and our e-commerce platform yourself. There you can access our database of unlicensed medicines and place an order at your convenience.
Here at AtrimusRx, we want to help as best we can; everyone is welcome to inquire and receive assistance with their medications and orders. Depending on whether you are a pharmacist, a prescribing physician, a veterinarian or a private person, some additional documentation such as applications, prescriptions, and permits may be required. Want more information about how to place an order or about these prerequisites? Contact us today and we’ll be happy to help! If you want to read more on your own, you can also visit the Swedish Medical Products Agency’s (Läkemedelsverket) website.
What are unlicensed medicines?
Want to know more?
We here at AtrimusRx are highly competent and possess extensive expertise when it comes to shortage and unlicensed medicines, from regulatory application to the Swedish Medicine Agency to order and delivery. If the medicine you are looking for is unavailable, we can help you find a suitable alternative quickly and easily.