ANNEX IV: Elements to be submitted
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1. |
A list of all the marketing authorisations affected by the notification or application. |
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2. |
A description of all the variations submitted, including: (a) in the case of minor variations of type IA, the date of implementation for each variation described;
(b) in the case of minor variations of type IA which do not require immediate notification, a description of all minor variations of type IA made in the last 12 months to the terms of the concerned marketing authorisation(s) and which have not been already notified.
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3. |
All necessary documents as listed in the guidelines referred to in point (b) of Article 4(1). |
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4. |
Where a variation leads to or is the consequence of other variations to the terms of the same marketing authorisation, a description of the relation between these variations. |
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5. |
In the case of variations to centralised marketing authorisations, the relevant fee provided for in Council Regulation (EC) No 297/95 ( 3 ). |
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6. |
In the case of variations to marketing authorisations granted by the competent authorities of Member States: (a) a list of those Member States with an indication of the reference Member State if applicable; (b) the relevant fees provided for in the applicable national rules in the Member States concerned.
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