Marketing information and Sunset Clause
- Published: March 31, 2020
- Last updated: March 17, 2025
Marketing information must be communicated to the Swedish Medical Products Agency (Swedish MPA) if it concerns medicinal products within national procedure, mutual recognition procedure, decentralised procedure and subsequent recognition procedure.
Marketing information
Obligation to inform regarding changed marketing status
The Swedish MPA must be notified through the Marketing service in LiiV before market introduction and marketing cessation (temporarily or permanently) of a medicinal product.
This reporting obligation applies to products authorized through mutual recognition procedure (MRP), decentralized procedure (DCP), national procedure (NP) and subsequent recognition procedure (SRP).
Way of reporting
Previously, the collection of information on marketing status for the Swedish market was conducted through separate reporting to the E-Health Agency and the Swedish MPA.
Starting November 28, 2024, the Swedish MPA will obtain information about changes in marketing status from the E-Health Agency's system, Supplier information in the VARA register (LiiV), via the Marketing Service. Marketing status updates will be retrieved once daily (at 8:00 PM) from LiiV.
This ensures:
- a shared national source for marketing status data
- a simplified processes for companies
- enhancement of the Swedish MPA ability to oversee and publish relevant information on medicine availability.
The Marketing Service introduces new fields when Marketed = "No" is selected in LiiV.
Additional guidance is available in the English LiiV Handbook found at E-Health Agency webbsite.
The previous form has been replaced by the Marketing service
The form "Marketing information for medicinal products - Sunset Clause", previously used for human medicinal products, has been replaced by the Marketing service as of 28 November 2024.
Medicinal products for veterinary use must also be reported
The reporting of marketing information for medicinal products for veterinary use, must be submitted not only to the Union Product Database (UPD) but also through the new service. This applies to nationally authorized products (under the procedures MRP, DCP, NP and SRP).
The Swedish MPA has decided that this requirement aligns with provisions in the Regulation (EU) 2019/6 (veterinary medicinal products regulation), which allows member states to establish national rules for retail and distribution. For medicinal products for veterinary use to be sold in Sweden, their status must also be updated in LiiV.
More information about the UPD is available on the European Medicines Agency’s (EMA) web site.
Justifications for the intended actions regarding cessation of marketing, has also been replaced by the Marketing Service in LiiV and shall no longer be submitted via e-mail to the Swedish MPA. In the Marketing service, the "Additional Information" field should be used for this purpose.
Reporting is now required at package level, unlike the previous system, which operated at product level.
Content of the notification of marketing status
Existing fields:
- On the market (Yes/No*)
- On the market from (date)*
Added fields:
- No longer on the market from (date)
For products where notification is mandatory, when this field is filled in, or the answer is "no" in the On the market -field (*), additional fields to fill in are displayed according to below:
- Marketing ceases (temporary/permanent)
- Reason (selection in drop-down list)
- Consent to publication of reason (Yes/No)
- Forecast for when the package will be available again (date, only applicable if marketing ceases temporarily, optional)
- Supplementary information to the Swedish MPA (optional)
For products that are not subject to mandatory notification, it is optional to fill out the relevant fields above. The option is displayed in an additional field according to below:
• Would you like to provide additional information about changes in marketing status to the Swedish MPA? (Yes/No)
For further details, see the LiiV-handbook.
The information on changes in marketing status and notifications of marketing cessations is collected to be able to overview availability of medicines and, with time, facilitate the publication of information regarding availability of medicinal products.
Medicinal products authorized under MRP, DCP, NP or SRP
For medicinal products that are nationally approved through mutual recognition (MRP), decentralized procedure (DCP), national procedure (NP), or subsequent recognition (SRP), it is mandatory to report the marketing status to the Swedish MPA.
Medicinal products for human use under these procedures must be reported at least two months before date of cessation.
Medicinal products for veterinary use under these procedures, must be reported without delay, and should include information about any actions the company intends to take. These actions must be reported before they are implemented and should be accompanied by a justification for the actions.
Therefore, the fields in the Marketing Service will be mandatory for the Marketing Authorization Holder (MAH)/representative to complete.
Centrally authorized medicinal products and parallel-imported/distributed medicinal products
Medicinal products authorized via the centralized procedure, as well as parallel-imported and parallel-distributed medicines, are not subject to mandatory reporting to the Swedish MPA.
Holders of a marketing authorization for medicinal products approved via the centralized procedure must inform the EMA about the start and cessation of sales.
For more information, visit the EMA's website:
Voluntary reporting to the Swedish Medical Products Agency
Information can be submitted voluntarily via the Marketing service in LiiV. The Swedish MPA encourages voluntary notifications, especially for marketing cessations that significantly affect the market or will require measures in healthcare or pharmacies.
Such notifications should include information on the date of the marketing cessation and the reason the medicinal product ceases to be available on the market.
Medicinal products whose marketing status is not managed in LiiV
In exceptional cases, LiiV is not used. This is the case if the order is not made via a dispensing pharmacy but e.g. the hospital pharmacy orders the medicine directly from the MAH/distributor (which applies to radiopharmaceuticals, medical gases, certain liquids, certain vaccines, serum and some antidotes). To gain access to LiiV, an application form can be downloaded from the E-Health Agency's website.
If there is a requirement to report changes in marketing status and LiiV is not used, please contact the Swedish MPA at registrator@lakemedelsverket.se for an alternative method of notification.
Terms and definitions
LiiV and VARA use the term "marketed/placed on the market" to reflect that a medicinal product is made available for sale on the Swedish market by the company. The terms used in communication about the availability of medicinal products from different parties may differ in Swedish due to the preference of different Swedish terms (for example on the market/for sale/available).
Legislation does not differentiate between a sales disruption caused by the company being unable to deliver the medicinal product in the quantity required for the Swedish market (a disruption of supply) or that a company decides to cease marketing of its product.
A temporary or permanent marketing cessation means the medicinal product is still authorized for sale. Pharmacies can continue to sell their remaining stock.
In order to withdraw the marketing authorisation for a medicinal product a specific application of withdrawal of marketing authorisation needs to be made to the Swedish MPA. Once the marketing authorisation ceases to be valid the product may no longer be sold in the Swedish market.
What does it mean for a medicinal product to be available for sale?
The Swedish MPA obtain information from LiiV for all medicinal products at package level (per NPL pack ID).
For a package for a medicinal product to be considered available on the Swedish market, the package should be available for sale (marked as “yes” for marketed status in LiiV), and being available for ordering from the distributor (wholesale level) and thereby accessible to the intended user.
When demand exceeds supply
If a medicinal product cannot be marketed during a specific period because it cannot be delivered in quantities sufficient to meet demand on the Swedish market, it is handled as a medicine shortage.
Guidance regarding marketing cessations
Difference between shortage and temporary cessation
Reporting of marketing cessations due to that a company cannot supply a medicinal product in quantities that meet national demand, that is a shortage. Shortage notifications are made using the Swedish MPA – E-service. This notification is required during an upcoming or ongoing shortage, while the company works to restore supply.
When a company decides to temporarily stop selling a medicinal product, it must update the marketing status in LiiV. Temporary cessations can be due to reasons related to quality, efficacy, safety, or market conditions and that the company assess that it is likely the product will be sold again in the future.
Marketing cessation of a package already reported as a shortage
When a company decides to stop selling a package that is already reported as a shortage, the company should set a date for the marketing cessation. In LiiV, the company fills in the date when the marketing status should be changed to "No".
The shortage notification is closed by the Swedish MPA when information about the marketing cessation is assumed to have reached concerned parties.
Reporting of shortage is not needed when marketing cessation is decided by the company
When a company decides to stop selling a medicinal product that is still available for sale, this must be updated in LiiV to indicate the date of cessation.
No shortage notification is required in this case.
An update in LiiV provides the Swedish MPA with information that a change in marketing status is taking place or will take place. It is possible to specify a future date for when sales will cease in LiiV. This date can also be updated later if necessary.
Depending on the product’s regulatory procedure, providing this information may be mandatory or voluntary.
Mandatory vs. voluntary reporting of marketing cessation
The same legislation determines which products are subject to mandatory reporting on marketing cessation, regardless of if the issue is a supply chain disruption causing a shortage or a decision from the company to temporarily or permanently stop selling the medicinal product on the Swedish market.
Mandatory Reporting applies to medicinal products authorized under mutual recognition (MRP), decentralized procedures (DCP), national procedures (NP), or subsequent recognition (SRP).
For medicinal products authorized under the Centralized Procedure, whether for humans or animals, as well as for parallel-imported and parallel-distributed medicines, reporting marketing cessation to the Swedish MPA is voluntary. It is important for the Swedish MPA to be informed of all marketing cessations that could lead to a medicine shortage.
The agency encourages companies to report as frequently as possible to ensure the most comprehensive information to be available to healthcare providers, pharmacies, and users.
Reporting Channels:
For products under mandatory reporting, completing the necessary fields in LiiV is obligatory when reporting temporary or permanent market cessations. For voluntary reporting in LiiV, the company must actively choose whether to notify the Swedish MPA to allow information to be shared via the Marketing Service or not.
Supplementary information to the Swedish MPA in the notification on marketing cessation
The text field "Supplementary information" in LiiV may be used to provide information if the change in marketing status may lead to a risk of shortage with patient impact, for example if equivalent alternative products are not available on the market.
The rationale for the chosen reason for the marketing cessation can also be provided here.
Please note that the intended actions to address and the reasons behind the cessation of veterinary medicinal products, which are to be notified to the competent authority before the action is taken, must be specified here.
This information is used only by the Swedish MPA and will be kept confidential. The intention is for this to facilitate the assessment of the impact of shortages. If necessary, the Swedish MPA will follow up on the information with the reporting company.
Notification of start of marketing
The Swedish MPA automatically retrieves information for all medicinal products when the marketing status is updated to "Yes" for a package in LiiV. No additional notification of placing a medicinal product on the market to the Swedish MPA is required. The previous form has been replaced by the Marketing service.
Parallel-traded medicinal products
Since parallel importers and parallel distributors of medicines are not strictly considered Marketing Authorization Holders (MAH), they are not subject to mandatory reporting requirements.
However, the availability of parallel-traded medicines often fluctuates. A voluntary notification to the Swedish MPA regarding a sales discontinuation can help provide a more complete picture of medicine availability. This contributes to ensuring that healthcare providers, pharmacies, and users have access to comprehensive and up-to-date information.
Centrally authorized medicinal products
The reporting obligation for centrally authorized medicines applies to the EMA. However, providing information on marketing status is equally important for all medicines, regardless of the approval procedure.
To ensure that healthcare providers, pharmacies, and users have access to the most comprehensive information possible, we encourage companies also to report marketing cessation for centrally authorized medicines directly to the Swedish MPA.
Reporting marketing status för medicinal products for veterinary use
The notification of sales starting or discontinuing (temporarily or permanently) for nationally authorized veterinary medicines must be submitted via LiiV. There is no need to send a separate email to the Swedish MPA with this information. There are additional provisions regarding veterinary medicinal products found in the Veterinary Medicinal Products Regulation.
Companies must report any changes in availability to the EU Product Database (UPD) as soon as they become aware, regardless of the approval procedure.
For nationally (MRP, DCP, NP and SRP) authorized medicines available for sale in Sweden, companies must promptly inform the Swedish MPA of sales status and planned actions. This notification should occur before implementing any measures and must include a justification for the actions. These updates are entered via the Marketing Service in LiiV.
For centrally authorized medicinal products for veterinary use, companies must notify the EU Commission about any availability changes. However, the Swedish MPA encourages companies to also report this information to the national agency to ensure that veterinary healthcare providers, pharmacies, and users have access to comprehensive and up-to-date information.
Marketing cessation vs withdrawal
When the Marketed field in LiiV is set to "No", the information is updated in the VARA database the following day. This means that the medicinal product can no longer be prescribed or ordered through prescription support systems.
A temporary or permanent cessation of sales means that the medicinal product remains authorized for sale, and pharmacies can continue to sell off their remaining stock. The date of cessation refers to when wholesalers can no longer distribute the product.
A withdrawal means that the marketing authorization for the medicinal product is withdrawn. This requires a withdrawal application to the Swedish MPA.
Notifying the phase-out of a pharmaceutical product
If a company plan to phase out a specific pack or all packages of a pharmaceutical product, this must be reported via the Marketing Service in LiiV.
If the phase-out is assessed to pose a risk of a medicine shortage, please include this information in the supplementary information section. The notification should specify the date when the change will take place and should be submitted as early as possible to allow healthcare services adequate time to adjust.
Notifying replacement of a ceased medicinal product
When a company plans to phase out a packaging or an entire medicinall product to replace it with another packaging or medicinal product, this must be reported via LiiV.
Regardless of whether the notification is mandatory or voluntary, it should include the date when the phased-out packaging/product will no longer be available from distributors.
In the supplementary information section, companies can provide details about the replacement product and specify which information can be shared publicly. This ensures that healthcare providers and stakeholders are informed, preventing concerns about potential shortages.
Sunset Clause
If a medicinal product is not placed on the market within three years or if the product is not present on the market for three consecutive years, the authorisation is terminated according to Sunset Clause.
All medicinal products for humans are covered by the Sunset Clause, but for traditional herbal medicines and homeopathy there are some exceptions. In Sweden, parallel imported products are not covered by the Sunset Clause rules.
With the change in veterinary legislation, medicinal products for veterinary use are no longer covered by the Sunset Clause. However, data linked to marketing information must in additon to the UPD (Union Product Database), also be registered in the Marketing Service.
More information is found in the section Marketing information.
Responsibility of the authorities
The Swedish MPA is the competent authority concerning that the rules on the Sunset Clause are followed for medicinal products approved within national, mutual recognition procedure and decentralized procedure.
The European Medicines Agency, EMA, is the competent authority concerning that the rules on the sunset clause are followed for medicinal products approved within the central procedure.
Exception from Sunset Clause
An annual fee that is paid in time is considered as a notification of the intention to market the product in Sweden. Thus, the approval does not expire because of Sunset Clause and no application for an exemption from Sunset Clause thus needs to be submitted in Sweden. Marketing status must however be notified, as stated in the section on Marketing information.
Regulations
Regarding medicinal products for human use, the start and cessation of marketing must be notified to the Swedish MPA according to chapter 4 section 18 of the Medicinal products Act (2015:315).
Registered traditional herbal medicinal products are not covered by chapter 4 Section 18, first paragraph on the obligation to provide information and for homeopathic medicinal products, point 2 (therapeutic effect) in the enumeration does not apply for special reasons.
Corresponding provisions to Swedish legislation are found in EU legislation.
Article 13(4) and Article, 14(4), (5) and (6) of Regulation (EC) No 726/2004.
Article 23a and Article 24(4), (5) and (6) of Directive 2001/83/EC.
Regarding medicinal products for veterinary use, the start and cessation of marketing must be notified in the UPD (Union product database), according to Article 58(6) of Regulation (EU) 2019/6 (Veterinary Regulation).
Before cessation of marketing, the national competent authority that has granted the marketing authorisation in the country where the medicinal product is available for sale must be informed of intended measures for this and justification. This must take place before such measures are taken, see article 58(13) of the same Regulation.