Healthcare & Pharmacy

If you manufacture, import, or distribute active pharmaceutical ingredients (APIs) for medicines, you must notify the Swedish Medical Products Agency (Läkemedelsverket) before starting operations. APIs are the active substances that give medicines their therapeutic effect.Your facility must comply with Good Manufacturing Practice (GMP) and is subject to inspection by Läkemedelsverket. After the initial notification, you must submit an annual update confirming your current operations and contact information. The notification requirement applies regardless of whether the APIs are intended for human or veterinary medicines.

Issued by: Medical Products Agency

Healthcare and social care providers are obligated to notify the Health and Social Care Inspectorate (IVO) of new or changed operations. This applies to operations under the Social Services Act (Socialtjänstlagen, SoL) and the Act concerning Support and Service for Persons with Certain Functional Impairments (Lagen om stöd och service till vissa funktionshindrade, LSS).Information about the different types of operations and how to apply is available on IVO's website. E-services and forms for registering different types of operations are available on the website.

Issued by: Health and Social Care Inspectorate

Needs-assessed sheltered housing (biståndsbedömt trygghetsboende) is a form of housing for elderly persons regulated under Chapter 26, Section 1, paragraph 2 of the Social Services Act (SoL). The operation requires a permit from the Health and Social Care Inspectorate (IVO) and offers elderly persons the opportunity to live in an environment with services and security.The difference between ordinary housing and needs-assessed sheltered housing is that the elderly person gains access to communal meals, cultural activities, and social interaction in a safe living environment. The operation must be conducted in accordance with the Social Services Act's requirements for quality and safety.

Issued by: Swedish Health and Social Care Inspectorate (IVO)

License to provide contact person support under the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS). The contact person can accompany on leisure activities, be someone to regularly talk and socialize with, provide advice in non-complex situations, and facilitate independent living in society.The license is issued by the Swedish Health and Social Care Inspectorate (IVO) and applies to the legal entity, not geographically specified operational units. This means the service can be provided in several municipalities under the same license.

Issued by: Swedish Health and Social Care Inspectorate (IVO)

The activity is conducted according to Section 9(6) of the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS) and requires a permit from the Health and Social Care Inspectorate (IVO). Short-term stay can be provided to both children and adults. The purpose is to provide respite for relatives and for the person with a disability to get recreation and a change of environment.Short-term stay can also be a way to contribute to a separation process between children and guardians or as preparation for those who are moving away from home. Short-term stay can be organized as a short-term home, as a camp or summer camp, and should be available regularly or in case of acute needs in the family.

Issued by: Swedish Health and Social Care Inspectorate (IVO)

Escort service under Section 9(3) of the Act (1993:387) concerning Support and Service for Persons with Certain Functional Impairments (LSS) is a service for persons with disabilities who need assistance getting to and from different places, participating in activities, or shopping. The activity requires a permit from the Health and Social Care Inspectorate (IVO) before it may be started.Escort service can be provided as regular or temporary assistance and is adapted to the person's needs and wishes. The permit is not geographically limited, meaning that the same permit applies to the legal entity regardless of which municipalities the activity is conducted in.

Issued by: Health and Social Care Inspectorate

To be allowed to sell certain over-the-counter (OTC) medicines in retail, the operation must first notify the trade to the Swedish Medical Products Agency. Only certain approved OTC medicines may be sold outside pharmacies. There is a search service on the Swedish Medical Products Agency's website where one can check which medicines are approved for sale in places other than pharmacies.Before sales can begin, the operation must ensure that it complies with all requirements in the legislation. This includes, among other things, a self-inspection program, correct purchasing and labeling, 18-year age limit, appropriate display and storage, and monthly/quarterly reporting to the eHealth Agency. The municipality exercises supervision over the operation.

Issued by: Medical Products Agency

Protected housing (skyddat boende) is a service under Chapter 26, Section 1 of the Social Services Act (SoL) that provides accommodation and protection in an acute phase for persons exposed to violence or threats. The service facilitates the transition to an independent, safe life with permanent housing. Support includes safety planning, counseling, assistance in contact with authorities, conversations, and practical help in daily life and housing. For accompanying children, services include safety planning, information, homework assistance, and support to process experiences of violence.Private actors have needed a permit from the Health and Social Care Inspectorate (IVO) since April 1, 2024, to professionally operate protected housing. Operations that were active before August 1, 2024, were required to submit an application to IVO by that date to continue operating while awaiting a decision.

Issued by: Health and Social Care Inspectorate

Pharmaceutical wholesale covers all handling of medicines from manufacturer release to retail, including procurement, storage, export, delivery, and sale. Even companies that own medicines without physically handling them are considered wholesalers and need a license.You must obtain a license from the Medical Products Agency (Läkemedelsverket) and follow Good Distribution Practice (GDP). Your operation must have a qualified person (sakkunnig person) with sufficient pharmaceutical competence and experience. Separate licenses are required for human and veterinary medicines. Läkemedelsverket inspects wholesale operations regularly to verify compliance with GDP standards and license conditions.

Issued by: Medical Products Agency

A permit is required to operate a pharmacy in Sweden. The Medical Products Agency (Läkemedelsverket) examines applications and assesses the applicant's suitability, that the business description is reasonable, that the pharmacy premises are appropriate and adequately staffed, and that no circumstances exist that constitute a prohibition against granting a permit.Pharmacy operations include retail sales of medicines to the public and to healthcare facilities. The activity must meet strict requirements for competence, premises, safety and quality assurance to ensure patient safety and correct medicine handling.

Issued by: Medical Products Agency

A license is required to provide personal assistance according to Section 9 § 2 of the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS). Personal assistance means that personal assistants help people with disabilities with things they cannot do themselves, so that they can live a life as similar to others of the same age as possible.Personal assistance can be provided to persons belonging to personal groups 1, 2 or 3 according to Section 1 § LSS, both adults and children. The license is not geographically limited and applies to the legal entity in several municipalities. Private individuals who arrange their own assistance only need to notify IVO.

Issued by: Health and Social Care Inspectorate

The activity is conducted according to Section 9(8) of the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS) and requires a permit from the Health and Social Care Inspectorate (IVO). Housing with special services for children or young people should be as similar to a home as possible.Therefore, only a small number of children or young people should live together and the housing should be located in a regular residential building and not in direct connection to other activities according to LSS or the Social Services Act (SoL).

Issued by: Swedish Health and Social Care Inspectorate (IVO)

A permit for daily activities under the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS) is required for operations that offer work tasks and activities adapted to the individual's interests and needs. The service is aimed at people of working age who are not working or studying.The activity is operated according to Section 9 § 10 LSS and requires a permit from the Health and Social Care Inspectorate (IVO). Daily activities may include both habilitation activities and more production-oriented tasks, but it is not a form of employment and the work is not salaried. However, the activity may aim to develop the individual's opportunity for future gainful employment.

Issued by: Swedish Health and Social Care Inspectorate (IVO)

To operate short-term residential care under the Social Services Act (SoL), you need a license from the Health and Social Care Inspectorate (IVO). Short-term care is a temporary form of accommodation with a specific purpose for a limited time, aimed at elderly people or persons facing significant difficulties due to physical, psychological, or other reasons.Common forms include respite care to relieve family caregivers, rehabilitation stays, and transitional care after hospitalization. IVO assesses the applicant's suitability, staff qualifications, premises, and quality management before issuing a license. IVO also exercises ongoing supervision and can revoke permits if care quality does not meet requirements.

Issued by: Swedish Health and Social Care Inspectorate (IVO)

A license is required to operate home care services according to Chapter 26 Section 1 § 6 of the Social Services Act (SoL). Home care services are granted by social services and consist of help with personal care and daily tasks such as cleaning, shopping, hygiene, help with meals, as well as housing support, escort services and respite care.The license is not geographically limited and applies to the legal entity, which means that the activity can be conducted in several municipalities within the framework of the same license. The license is applied for at the Health and Social Care Inspectorate (IVO).

Issued by: Health and Social Care Inspectorate

A license is required to operate supported housing according to Chapter 26 Section 1 § 1 of the Social Services Act (SoL). Supported housing can consist of apartments or a coherent facility and is aimed at children and young people aged 16-17 (with special reasons) who have previously been placed for social problems, live in a conflict-filled home situation, or came as unaccompanied children to Sweden.The content of the activity must be adapted to the individual's individual needs and conditions and designed so that the stay is experienced as meaningful. The license is applied for at the Health and Social Care Inspectorate (IVO).

Issued by: Health and Social Care Inspectorate

A permit or notification is required for all handling of radioactive substances or equipment that can produce ionizing radiation, unless the activity has been exempted from the Radiation Protection Act. The Swedish Radiation Safety Authority (Strålsäkerhetsmyndigheten) is the supervisory authority and receives permit applications and notifications.Activities requiring permits include nuclear installations, medical X-ray and radiation treatment, industrial radiography and handling of high-activity radiation sources. Activities requiring notification include dental X-rays, veterinary X-rays of small animals and handling of low-activity radiation sources. Activities may not begin until a permit has been granted or notification has been confirmed.

Issued by: Swedish Radiation Safety Authority

Private operators providing outpatient care and day services under the Social Services Act (SoL) need a permit from the Health and Social Care Inspectorate (IVO). This covers day care for elderly people, persons with disabilities, or individuals with substance abuse issues where the care is extensive and significantly affects the person's daily life.IVO examines the applicant's suitability, staff competence, premises, and quality management systems. The permit must be obtained before the operation starts. IVO also exercises ongoing supervision and can revoke permits if the operation fails to meet quality and safety requirements under social services legislation.

Issued by: Health and Social Care Inspectorate (IVO)