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Indicateur de change ema


indicateur de change ema

reasons in older products. The introduction of a new pack size of 120 tablets for the 20mg strength is considered outside the range of packs and should be classified as variation.II. Il est représenté par une ligne mobile lissée triple. Additionally it should be confirmed that any changes introduced by the omitted CEP update(s do not affect the quality of the AS and/or. The MAH should also clearly indicate in the 'Present/Proposed' section all changes introduced in the CEP between the latest approved version and the new revision, including all revisions that were not notified.

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What changes can I submit under a single type II scope? Such changes require regulatory assessment and are to be handled as Type IB or II variations as appropriate. For the categories listed above and other variations related to specifications of active ingredients, excipients, finished product, packaging material or measuring or administration device, the deletion of an obsolete parameter is given as an example. For the addition of a new pack size where the number of units of the pack is outside the range of the currently approved pack sizes for the strength and pharmaceutical form, applicants should submit a IB variation.II. When applying for an update of an approved CEP, the MAH should refer to the previously agreed version of the CEP within the 'Present/Proposed' section of the application form.

Indicateur de change ema
indicateur de change ema

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