Risk management plan

All new applications for marketing authorisations must include a risk management plan (RMP), irrespective of the procedure under which the medicinal product is authorised.

Content of the risk management plan

A risk management plan contains information on important identified and potential risks as well as missing data.

The risk management plan describes the activities that are being carried out to identify and assess the risks associated with the medicinal product, such as adverse reaction reporting, signal assessment and planned follow-up safety studies, known as the pharmacovigilance plan.

The risk management plan also describes the measures being taken to minimise identified risks, known as the risk minimisation plan.

Risk minimisation

Routine risk minimisation measures apply to all medicinal products and consist of the summary of product characteristics, package information leaflet, labelling, packaging size and prescription status.

For some risks, routine risk minimisation measures are not sufficient and additional measures are needed. These may include, for example, educational materials, pregnancy prevention programmes or requirements regarding controlled distribution.

If these are stipulated as conditions in the marketing authorisation, they must be examined by the Swedish MPA before the product is placed on the market.

Updates to the risk management plan

The risk management plan is continually updated throughout the lifespan of the medicinal product, as new knowledge about the product becomes available.

Updates to the risk management plan are carried out as a variation procedure, either independently or in conjunction with other variations.

When an updated risk management plan is submitted to the Swedish MPA, the changes that have been made must be clearly marked.

Summary of the risk management plan

All risk management plans must include a summary of the plan, known as an RMP summary.

Summaries of the RMP will be published for medicinal products for which Sweden is the Reference Member State and for purely national approved products. The RMP summaries are published at our information service Läkemedelsfakta (in Swedish).

EMA publishes RMP summaries for centrally authorised medicinal products on its website.

Exemption for traditional herbal medicinal products

An exemption applies to registration holders for traditional herbal medicinal products.

• A risk management plan does not need to be submitted in applications for traditional herbal medicinal products.

Veterinary medicinal products

According to the Regulation (EU) 2019/6, there is no obligation of a risk management plan. However, a risk management system must be in place, regardless of the authorisation procedure of the veterinary medicinal product.