Guideline

The implementation period regarding changes in the labelling or package leaflet may be longer or shorter than six months, based on the Swedish Medical Products Agency's assessment in each individual case. Below are some examples of how different types of changes in the labelling or package leaflet may be assessed.

• The Swedish Medical Products Agency can decide that parallel sales of packaging with previously approved and new labelling/package leaflet may take place for a limited transitional period.
• When it comes to certain changes (such as name, strength or pharmaceutical form, serious safety updates, certain contraindications and quality changes, etc.), the Swedish Medical Products Agency may decide to prohibit parallel sales, or alternatively to limit the time of parallel sales.
• After name changes, parallel sales of packaging with previously approved and new labelling/package leaflet are usually allowed for one month. The implementation date for the new name to be visible in the systems can be adjusted according to the applicant's wishes.
• After MAH changes, parallel sales of packaging with previously approved and new labelling/package leaflet are usually allowed for six months. The implementation date for when the MAH change will be visible in the systems can be adjusted according to the applicant's wishes.
• For certain non-urgent changes, or purely administrative changes, to the package leaflet and labelling, a longer implementation period of the new labelling can be decided. In such cases, the Swedish Medical Products Agency can decide on an implementation period of up to twelve months. Non-urgent changes are primarily changes that do not affect safety, handling or administration of the medicinal product.