Danish Drug Standards: Determining storage conditions for products

Updated 29 September 2023

None
Do not store above 30°C
Do not store above 25°C

applicable to products containing biological or chemically synthesised active substances.

The Danish Medicines Agency determines storage conditions based on the guidelines described in the Danish Drug Standards.

In Denmark, it is a requirement to include on the label the storage condition ‘Do not store above 25°C, whereas it is optional to include ‘Do not store above 30°C on the label.

As regards the storage conditions

  • None
  • Do not store above 30°C, and
  • Do not store above 25°C
    the following applies:

No storage conditions

The product meets the requirement of the finished product specification when stored at 25°C/60%RH during the approved shelf life, and at 40°C/75%RH for 6 months.

Do not store above 30°C

The product meets the requirement of the finished product specification when stored at 25°C/60%RH during the approved shelf life, and at 30°C/60%RH for 12 months. But the product does not meet the requirement of the finished product specification when stored at 40°C/75%RH for 6 months.

Do not store above 25°C

The product meets the requirement of the finished product specification when stored at 25°C/60%RH during the approved shelf life, but does not meet the requirement of the finished product specification when stored at 30°C/60%RH for 12 months.

The package is only required to include information for the user when relevant and documented. For this reason, the storage condition Do not store above 25°C is only approved when stability issues at 30°C/60%RH have been observed.

Likewise, the storage condition Do not store above 30°C is only approved when stability issues at 40°C/75%RH have been observed.

However, stability testing for older marketed products has not always been performed at 30°C/60%RH and 40°C/75%RH. It is therefore not possible to determine storage conditions according to the above guidelines. Previously, the three above-mentioned storage conditions were comprised by the designation Normal temperature. The Danish Medicines Agency is changing this condition according to the following guidelines:

  • The storage condition Normal temperature is changed to None if there are no indications that the product is temperature sensitive.
  • The storage condition Normal temperature is changed to Do not store above 25°C if:
    – no stability studies have been performed at 30°C/60%RH and/or 40°C/75%RH, but the company can demonstrate that the product is unstable at higher temperatures, e.g. in the form of literature studies or stability tests on the active substance. However, the company is required at a later stage – e.g. in connection with changes to the product – to initiate stability studies of accelerated storage conditions.

    – the company does not hold stability data at 30°C/60%RH, but holds stability data for 6 months at 40°C/75%RH showing that the requirements of the specification cannot be met.
    Here again, the company is required – at a later stage – to initiate stability studies at 30°C/60%RH, for example in connection with changes to the product.

The storage condition Normal temperature is changed in connection with a renewal of the marketing authorisation. The company’s considerations in this respect must therefore be submitted with the application. If the company wants to change the storage condition, but not as part of the renewal of the marketing authorisation, a variation, Type I, no. 42b, must be submitted.

An exemption from the above procedure applies to older marketed products whereby part II is requested to be updated with a view to mutual recognition with Denmark as reference member state. In this case, the stability tests must be performed according to the existing guidelines as described in the Danish Drug Standards.