Changes not connected to the Summary of Product Characteristics

Human Medicines

An article 61(3)-notification is a change to the patient information leaflet and/or the labelling that does not affect the Summery of Product Characteristics.

Changes affecting the English language text

National changes

Notification form for national changes, that is:

• changes to nationally approved products or
• changes to the national product information for products approved via the mutual recognition procedure.

Product information

Timetable

The evaluation time is 90 days.

Veterinary Medicines

A change to the patient information leaflet and/or the labelling that does not affect the Summery of Product Characteristics should be submitted accordingly to current guidelines.

National changes

A Change to the Swedish national translation of the patient information leaflet and/or the labelling and that does not affect the Summery of Product Characteristics can be submitted to the Swedish MPA as a variation requiring assessment (VRA) under category G.I.15.z or as a variation not requiring assessment (VNRA) under category C.10.a-c if current conditions can be fulfilled. The application should be submitted on the application form for variations (VRA) or registered in the UPD (VNRA).

You can find the application forms on the EMA website.

Labelling changes that previous could be sent to the Swedish MPA for information only should be sent as a VNRA.

Product Information

Timetable

The evaluation time is 60 days for a VRA and 30 days for a VNRA.