[2] Minor Variation – Prior Approval (MiV-PA1 to MiV-PA36)

MiV-PA1

Change of drug product name

MiV-PA2

Change of product labeling (in accordance to country specific labeling requirement)

MiV-PA3

Addition or replacement of the company or party responsible for batch release

MiV-PA4

Addition or replacement of alternative manufacturer/site of drug substance [where European Pharmacopoeial Certificate of Suitability (CEP) is available]

MiV-PA5

Change of batch size of drug substance [where European Pharmacopoeial Certificate of Suitability (CEP) is not available]

MiV-PA6

Change of in-process controls applied during the manufacture of the drug substance [including tightening and addition of new in-process test and where European Pharmacopoeial Certificate of Suitability (CEP) is not available]

MiV-PA7

Minor change of manufacturing process of the drug substance [where European Pharmacopoeial Certificate of Suitability (CEP) is not available]

MiV-PA8

Change of the specification of drug substance

MiV-PA9

Change of the test procedure of non-compendial drug substance

MiV-PA10

Change of shelf-life or retest period for drug substance

MiV-PA11

Change of storage condition for drug substance

MiV-PA12

Revision of European Pharmacopoeial Certificate of Suitability (CEP) of drug substance

MiV-PA13

Change of batch size of non-sterile drug product

MiV-PA14

Reduction or removal of overage

MiV-PA16

Quantitative change in coating weight of tablets or weight and/or size of capsule shell for immediate release oral dosage form

MiV-PA15

Qualitative or quantitative change of excipient

MiV-PA17

Change of the colouring agent/flavouring agent/capsule shell colour of the product

MiV-PA18

Deletion of the solvent/diluent for the drug product

MiV-PA19

Change of in-process controls applied during the manufacture of the drug product (including tightening and addition of new in-process test)

MiV-PA20

Minor change of the manufacturing process for non-sterile product

MiV-PA21

Change of specifications of non compendial excipient

MiV-PA22

Change of a test procedure for an excipient, including replacement of an approved test procedure by a new test procedure

MiV-PA23

Change in the source of empty hard capsule

MiV-PA24

Change of release and shelf-life specifications of the drug product

MiV-PA25

Change of imprints, bossing or other markings on the tablets or printing on capsules including addition or change of inks used for product marking

MiV-PA26

Change of dimensions and/or shape of tablets, capsules, suppositories or pessaries without change in qualitative and quantitative composition and mean mass

MiV-PA27

Change in the test procedure of the drug product (including replacement or addition of a test procedure)

MiV-PA28

Change in primary packaging material for non-sterile product a) Qualitative and quantitative composition and/or b) Type of container and/or c) Inclusion of primary packaging material

MiV-PA29

Addition or replacement of a manufacturer for secondary packaging

MiV-PA30

Change of pack size/fill volume and/or change of shape or dimension of container or closure for non-sterile product

MiV-PA31

Change of outer carton pack sizes for a drug product

MiV-PA32

Addition or replacement of measuring device for oral liquid dosage forms and other dosage form

MiV-PA33

Reduction of shelf-life of the drug product

MiV-PA34

Change of storage conditions of the drug product (Increasing from the approved storage condition)

MiV-PA35

Addition or replacement of alternative site for primary packaging (direct contact with drug product) for non-sterile product

MiV-PA36

Addition or replacement of the company or party responsible for quality control testing site