Notification of Changes to Labelling and Package Leaflets in Accordance with Article 61(3)

The form is used to inform the Medicines Authority of more than one change relating to a product. One form per product must be filled in.

Legislation

Subsidiary Legislation 458.50medicinal Products (Package Leaflets And Labelling) (Transitional Arrangements) Regulations

Information

Information on Changes to Labelling and Package Leaflets in Accordance with Article 61(3)

.

GO

Application

Application form for Changes to Labelling and Package Leaflets in Accordance with Article 61(3).

GO

Competent Authority

Medicines Authority

GO

 

 

 

 

 

 

 

last updated June 2026

Skip to content