Limited stock of medicinal products

Social welfare’s assisted living units can store a limited stock of medicinal products intended for shared use.

A permit for keeping a limited stock of medicinal products may be granted to an assisted living unit maintained by social welfare services under the conditions laid down in the Medicines Act. The permit may be granted to an operating unit that keeps a limited stock of medicinal products intended for shared use for clients' unforeseen and sudden medication needs and for situations in which a client’s known illness or condition worsens and requires medication quickly.

However, the pharmacotherapy of the residents of the units is mainly carried out using personally prescribed medicine picked up from the outpatient pharmacy, as has been the case until now.  

A private service provider must apply for the permit, and a public operating unit must submit a notification to the Regional State Administrative Agency or Valvira before setting up a limited stock of medicinal products.

The Medicines Act regulates limited stocks of medicinal products. The same conditions for limited stocks of medicinal products apply to both public and private service providers.

Information on the limited stock of medicinal products of both public and private service providers is stored in the joint register of Valvira and Regional State Administrative Agencies. The controller is Valvira.

Processing times for permits and notifications

Our permit processing is occasionally busy.

Information on permits

The permit we grant to a private service provider to maintain limited stock of medicinal products costs EUR 1165 if we do not carry out a separate inspection of the stock of medicinal products. The permit costs EUR 1,750 if we inspect the stock of medicinal products before granting the permit.

Change decision based on a notification concerning essential changes to the licence decision on a limited stock of medicinal products (section 68, subsection 5) EUR 585

Fee charged for processing a notification concerning essential changes to the limited stock of medicinal products, if a licence change decision is not required (section 68, subsection 5) EUR 200

Fee charged for processing a notification concerning the discontinuing of the maintenance of a limited stock of medicinal products (section 68, subsection 5) EUR 100

Fee charged for processing a notification submitted by a wellbeing services county for a limited stock of medicinal products located in a social welfare-operated assisted living unit (section 68, subsection 4) EUR 950

Decision concerning the supervision of a limited stock of medicinal products, including inspection (section 71) EUR 1,450

Decision concerning the supervision of a limited stock of medicinal products (section 71) EUR 780

Our fees are laid down in the Government Decree on Fees for Regional State Administrative Agencies. If you disagree with the Regional State Administrative Agency’s invoice, you can contest it within six months.

Our service price list

If you are a private service provider and want to establish a limited stock of medicinal products in your operating unit, you need a permit. You cannot set up a limited stock of medicinal products until you have been granted the permit for it.

If you are a public service provider and want to establish a limited stock of medicinal products in your operating unit, submit a notification of registering the stock before establishing it.

Submit your permit application to the Regional State Administrative Agency in the area where your operating unit is located. Operating units located in Åland should submit a permit application to the Regional State Administrative Agency for Southwestern Finland. If you have operating units located in more than one area of operation of Regional State Administrative Agency, apply for a permit from Valvira.

Municipalities are obliged to notify the Regional State Administrative Agency in the area where the municipality is located of a limited stock of medicinal products. However, the operating units of municipalities located in Åland submit a notification to the Regional State Administrative Agency for Southwestern Finland. Municipalities must ensure that their operating units meet the requirements for establishing a stock of medicinal products laid down in law. 

Application process

You can submit an application for a permit and a notification of a limited stock of medicinal products using a secure form. You can use the same form to apply for a permit and to notify of significant changes.

If the application or notification cannot be submitted using the secure form, you can also download or print the form and send it to the registry of the Regional State Administrative Agency either as an e-mail attachment or by post.

The establishment and maintenance of limited stock of medicinal products shall be subject to the following conditions:

  1. A person-in-charge has been appointed for the limited stock of medicinal products. The person in charge must be regularly present in the operating unit. In addition, they must be either a physician working in the unit in question or a licensed health care professional with sufficient competence and training in pharmacotherapy.
  2. The maintenance of a limited stock of medicinal products and the use of the medicines in it must be based on a pharmacotherapy policy approved by a licensed physician.
  3. In the operating unit, pharmacotherapy using medicine from a limited stock of medicinal products may only be provided by licensed health care or social welfare professionals or ones with a protected occupational title who have the necessary training in pharmacotherapy and whose competence in pharmacotherapy has been confirmed. In addition, there must be a sufficient number of members of staff that meet the above-described criteria available at all times of the day.
  4. The limited stock of medicinal products must be kept in locked and appropriate facilities, and the medicines in the stock must be kept separate from the personal medicines of the clients of the operating unit. In addition, the monitoring of the consumption of medicines must be properly organised.
  5. The stock of medicines is restricted in the pharmacotherapy policy to medicinal products that meet the clients' unforeseen and sudden needs for pharmacotherapy and are needed when a known illness or condition worsens and requires quick treatment with medicine.
  6. The operating unit must also ensure that it is possible for clients to get access to medical services in a manner that meets their need for treatment at all times.

When you apply for a permit or submit a notification for a limited stock of medicinal products, you must attach the section on limited stock of medicinal products described in the pharmacotherapy policy of the operating unit.

Private service providers and wellbeing service counties must notify of any significant changes related to the maintenance of the limited stock of medicinal products and the dismantling of the stock of medicinal products. The notification shall be made to the authority that has processed the application for authorisation or notification of the limited stock of medicinal products of the operating unit concerned.

Significant changes to the limited stock of medicinal products include, for example:

  • essential change in the company form of the operating unit
  • significant change in the services offered or number of customers
  • change of the person in charge for the limited stock of medicinal products or the licensed physician who approved the pharmacotherapy plan. 

In the permit application or notification, you are asked to provide information on the following things:

  • basic information about the service provider and the operating unit
  • the service provider's business ID,
  • the OID code of the operating unit,
  • contact details of the persons in charge for the stock of medicinal products
  • the number of personnel involved in pharmacotherapy using medicines from the stock.

If you do not know your operating unit's OID code, you can check it in the THL register of public and private social welfare and health care organisations. https://koodistopalvelu.kanta.fi/codeserver/pages/classification-view-page.xhtml?classificationKey=421&versionKey=501

 

Contact information for registries