Sfc Type 2 Regulated Activity
Elvisa Schimke
Companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. The sections below include links to documents that provide detailed information on these formats and other information related to filing submissions electronically.
Some documents are only available and labeled as "available upon request". When you click the link to these documents, an email message should appear with information pre-filled; simply 'Send' this message. Alternatively, you can create an email to no-reply.erevi...@hc-sc.gc.ca, and use the requested subject line as specified for each document below.
We describe each regulated activity and give some examples of services that are likely to carry on these activities. If the general exceptions and exemptions do not apply to you, you must register for each regulated activity that you provide, unless a specific exemption applies.
You need to be sure that the service you provide is covered by the regulated activities you register for. To do this, check all the activities, read the guidance and use the diagrams to help you decide if you need to register for that activity.
However, wherever nursing care or personal care is provided in its own right (not as part of another regulated activity), then a provider may need to register for it as a regulated activity, even if the provider is registered for other regulated activities.
The regulated activity of Personal care involves providing personal care for people who are unable to provide it for themselves because of old age, illness or disability. The personal care must be provided in the place where those people who need it are living at the time when the care is provided.
For example, this includes personal care provided through domiciliary or homecare services, and housing with care or supported living services. Sometimes, people receiving personal care live in accommodation where it is a requirement of occupation that they both need and receive a care service while living there. For the care service to be correctly registered for the regulated activity of Personal care, there must be a real separation between the provision of personal care and the accommodation agreements. See additional guidance on supported living and extra care housing services.
This regulated activity does not apply if your service does not provide the activities defined as personal care. See Regulation 2 and Schedule 1(1) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 for full details.
For example, you do not need to register if you only provide housing support or social support (such as help with shopping), but no tasks that are included in the definition of personal care. Similarly, you do not need to register for the activity if you only provide support to administer, prompt or supervise medicines but do not intend to provide any of the activities defined as personal care.
Shared lives schemes (referred to in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) should register only for the regulated activity of Personal care and not the regulated activity Accommodation for persons who require nursing or personal care. This is because:
Shared lives schemes should only register for Personal care where they provide placements for people with personal care needs. If they do not provide this type of placement, they will be out of scope for this regulated activity. See what we mean by shared lives schemes in our glossary of terms.
Our Housing with care guidance gives more information about regulated activities for personal care services provided to people living in specialist schemes such as supported living and extra care housing.
This regulated activity applies where residential accommodation is provided together with nursing care or personal care as a single package, for example nursing or personal care delivered in a care home setting.
A single package means the person using the service cannot choose to receive personal care from another provider while they are living in the accommodation. In the same way, to receive the accommodation they are required to receive their personal care from one specified provider. The accommodation and the care will usually be from the same provider, but they do not need to be, as long as any contractual arrangements make clear who is responsible for carrying on this regulated activity.
If accommodation and personal care are provided separately and people living in the accommodation can choose a different provider to meet their personal care needs, then it may be a supported living or extra care housing service. In this case the regulated activity of Personal care may apply.
You do not have to additionally register for the activities of Personal care or Nursing care if you provide the regulated activity of Accommodation for persons who require nursing or personal care. Where someone living in a care home needs nursing care, this may be provided by care staff where the tasks can be delegated appropriately by a listed healthcare professional (see what this means in our glossary of terms) who is employed by a provider registered to carry on the regulated activity of Treatment of disease, disorder or injury (for example, a district nursing service). See more information on delegation in Treatment of disease, disorder or injury.
You may need to apply for other regulated activities where these apply. For example, providers of care homes with nursing are likely to need to also register for Treatment of disease, disorder or injury if they employ registered nurses or other listed professionals who carry on this regulated activity. There may be exceptions to this principle, but only when registered nursing staff are not employed in their professional capacity and do not actually carry out the treatment for a disease, disorder or injury.
In some cases, this activity includes accommodation together with personal or nursing care provided in an establishment in the further education sector. For this activity to apply in the further education sector, more than 10% of the students receiving both accommodation and education at the establishment must also be receiving personal or nursing care. We will normally judge this by looking at the number of students over a 12 month period, rather than just on a single day.
An establishment in the further education sector means an establishment conducted by a further education corporation, or an establishment designated as such by an order of the Secretary of State for Education.
If you provide a shared lives service, you should register only for the regulated activity of Personal care and not for the regulated activity of Accommodation for persons who require nursing or personal care. See more information on shared lives schemes under the Personal care activity.
The treatment for substance misuse does not necessarily need to be provided in the same place as the accommodation, it could be on a different site. For example, the treatment may be delivered in a community setting such as a day centre or community centre, with the people accommodated in separate facilities somewhere else. However, the accommodation and the treatment must be linked so that the accommodation is provided because someone requires and accepts treatment.
You do not have to additionally apply to register for the regulated activities of Personal care or Nursing care if you provide this activity. This is because they would be covered as part of the treatment you provide for the substance misuse. The only exception to this would be if you also provide personal or nursing care as a separate service (for example a domiciliary or homecare service).
In the same way, you do not also have to apply to register for Treatment of disease, disorder or injury. This is because the treatment for substance misuse is covered under the activity of Accommodation for persons who require treatment for substance misuse. You would only have to apply for Treatment of disease, disorder or injury if you provide other treatments that are separate from the treatment of substance misuse. For example, treating substance misuse includes detoxification, but you would also have to register for Treatment of disease, disorder or injury if:
This regulated activity applies to the treatment of disease, disorder or injury in any setting, for example hospitals, clinics, hospices, ambulances, GP and dental surgeries, community services, and care homes.
Sometimes, Treatment of disease, disorder or injury is provided as only one part of a service, for example in a large care home that has just a few intermediate care or specialist palliative care beds. If the activity is carried out by or under supervision of a listed healthcare professional employed by the provider, you will still need to register for it in addition to any other activities that you may need to register for your service.
If a multi-disciplinary team includes one of these healthcare professionals (or a social worker in the case of mental health treatment) involved in their professional capacity, then the activity will be within scope and needs to be registered.
The role of nursing associate introduced in 2019 is not included in the list of healthcare professionals who can carry out activities covered by the regulated activity of Treatment of disease, disorder or injury. This means that a provider cannot register for this regulated activity based on the employment of nursing associates alone, though they may be employed to work as part of a nursing team with other listed healthcare professionals.
The professional standards that registered nurses, midwives and nursing associates must uphold are set out in The Code: Professional standards of practice and behaviour for nurses, midwives and nursing associates 2019 (Nursing and Midwifery Council). Registered nurses, midwives and nursing associates must act in line with the Code. This includes requirements about accountability for decisions to delegate tasks and duties, and for the outcome of the delegated tasks. The Royal College of Nursing also provides guidance on accountability and delegation.
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