Implementation date for variations that do not affect Norwegian product information
Published:
Changes
Variations that do not affect the norwegian product information must be implemented within 6 months of the approval date, unless otherwise agreed with the Norwegian Medical Products Agency (NOMA). Delays beyond this 6-month period must be applied for as batch-specific variations. NOMA may set a shorter implementation deadline when expedited implementation of a variation is necessary, for example due to patient safety.
Medicinal Products for human use
Type IB and type II variations must be implemented within 6 months of the approval date, unless otherwise agreed with NOMA. The implementation date of the variation must be indicated in the application form. Variations to the marketing authorisation must be implemented in accordance with the provisions of Variation regulation (EC) No 1234/2008, Article 24
Medicinal Products for veterinary use
Variations requiring assessment (VRA) must be implemented within 6 months of the approval date, unless otherwise agreed with NOMA. The implementation date of the variation must be indicated in the application form. Variations to the marketing authorisation that require assessment (VRA) must be implemented in accordance with the provisions of Regulation on veterinary medicinal products (EU) 2019/6, Article 68.