Minor Variation – Notification (MiV-N1 to MiV-N13)

MiV-N1

Change in name and/or address of the marketing authorization holder

MiV-N2

Change of product owner

MiV-N3

Change in ownership of manufacturer

MiV-N4

Change of the name or address (for example: postal code, street name) of the manufacturer of drug product

MiV-N5

Change of the name or address (for example: postal code, street name) of the company or manufacturer responsible for batch release

MiV-N6

Change of the name and/or address (for example: postal code, street name) of a manufacturer of the drug substance

MiV-N7

Withdrawal/deletion of the alternative manufacturer(s) (for drug substance and/or drug product and/or packager)

MiV-N8

Renewal of European Pharmacopoeial Certificate of Suitability (CEP)

MiV-N9

Change of release and/or shelf-life/re-test specifications and/or test procedure of the drug product and/or drug substance and/or excipient, following the updates in the compendium

MiV-N10

Deletion of pack size for a product

MiV-N11

Minor change in the manufacturing process of an immediate release solid oral dosage form, semi solid or oral solutions

MiV-N12

Change in any part of the (primary) packaging material not in contact with the finished product formulation (such as colour of flip-off caps, colour code rings on ampoules, change of needle shield (different plastic used)

MiV-N13

Change of the name or address (for example: postal code, street name) of the company or party responsible for quality control testing site