Fees in the RS (in accordance with Rules on fees, Official ... - jazmp
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Fees in the RS (in accordance with Rules on fees, Official ... - jazmp

Fees in the RS (in accordance with Rules on fees, Official ... - jazmp Fees in the RS (in accordance with Rules on fees, Official ... - jazmp

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IB as ong>theong> maong>inong> variation Exemption: variation to change ong>theong> name and/or address of ong>theong> MAH or variation to changes to an existong>inong>g pharmacovigilance system as described ong>inong> ong>theong> DDPS Exemption: variation to change (ong>inong>vented) name of ong>theong> medicong>inong>al product ong>inong> one or more MS (ong>inong>cludong>inong>g ong>inong> Slovenia) Up to 20 medicong>inong>al products: 100 poong>inong>ts More than 20 medicong>inong>al products: 200 poong>inong>ts Up to 20 medicong>inong>al products: 100 poong>inong>ts More than 20 medicong>inong>al products: 200 poong>inong>ts Up to 20 medicong>inong>al products: 100 poong>inong>ts More than 20 medicong>inong>al products: 200 poong>inong>ts More than 50 medicong>inong>al products: 400 More than 50 medicong>inong>al products: 400 More than 50 medicong>inong>al products: 400 poong>inong>ts poong>inong>ts poong>inong>ts / 110 poong>inong>ts basic fee 800 poong>inong>ts basic fee Worksharong>inong>g procedures (Art. 20 of Commission Regulation (EC) 1234/2008) / 1 st MA 100 % fee (ong>inong> case of grouped variations takong>inong>g ong>inong>to account ong>theong> provisions for calculation fees for grouped variations) 1 st MA 100 % fee (ong>inong> case of grouped variations takong>inong>g ong>inong>to account ong>theong> provisions for calculation fees for grouped variations) Notification for product ong>inong>formation or labellong>inong>g amendment not connected ong>withong> SPC 20 poong>inong>ts basic fee +20 poong>inong>ts for each additional strength and/or pharmaceutical form Each additional MA 75 % fee of 1 st MA 20 poong>inong>ts basic fee +20 poong>inong>ts for each additional strength and/or pharmaceutical form Each additional MA 75 % fee of 1 st MA 20 poong>inong>ts basic fee +20 poong>inong>ts for each additional strength and/or pharmaceutical form Review of educational material 70 poong>inong>ts basic fee* * no fee for additional strength and/or pharmaceutical form ong>inong> ong>theong> same application 4/7

Type of application National procedure ong>RSong> as CMS (MRP/DCP) ong>RSong> as RMS (MRP/DCP) Renewal 300 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) 250 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) 2350 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 50 poong>inong>ts for each additional strength and/or pharmaceutical form + 50 poong>inong>ts for each additional strength and/or pharmaceutical form + 500 poong>inong>ts for each additional strength and/or pharmaceutical form PSUR assessment 300 poong>inong>ts 50 poong>inong>ts 2350 poong>inong>ts Type of application National procedure Transfer of MA Cessation of validity of MA 50 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 50 poong>inong>ts for each additional strength and/or pharmaceutical form but not more than 200 poong>inong>ts 20 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) Type of application Scientific advice (basic advice on documentation preparation) Scientific advice (complex advice on documentation preparation) Scientific advice (advice on content of documentation) 100 poong>inong>ts 300 poong>inong>ts 700 poong>inong>ts 5/7

IB as <str<strong>on</strong>g>the</str<strong>on</strong>g> ma<str<strong>on</strong>g>in</str<strong>on</strong>g> variati<strong>on</strong><br />

Exempti<strong>on</strong>: variati<strong>on</strong> to<br />

change <str<strong>on</strong>g>the</str<strong>on</strong>g> name and/or<br />

address of <str<strong>on</strong>g>the</str<strong>on</strong>g> MAH or<br />

variati<strong>on</strong> to changes to an<br />

exist<str<strong>on</strong>g>in</str<strong>on</strong>g>g pharmacovigilance<br />

system as described <str<strong>on</strong>g>in</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g><br />

DDPS<br />

Exempti<strong>on</strong>: variati<strong>on</strong> to<br />

change (<str<strong>on</strong>g>in</str<strong>on</strong>g>vented) name of<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al product <str<strong>on</strong>g>in</str<strong>on</strong>g><br />

<strong>on</strong>e or more MS (<str<strong>on</strong>g>in</str<strong>on</strong>g>clud<str<strong>on</strong>g>in</str<strong>on</strong>g>g<br />

<str<strong>on</strong>g>in</str<strong>on</strong>g> Slovenia)<br />

Up to 20 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

More than 20 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 200<br />

po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

Up to 20 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

More than 20 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 200<br />

po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

Up to 20 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

More than 20 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 200<br />

po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

More than 50 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 400 More than 50 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 400 More than 50 medic<str<strong>on</strong>g>in</str<strong>on</strong>g>al products: 400<br />

po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts<br />

/ 110 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee 800 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee<br />

Workshar<str<strong>on</strong>g>in</str<strong>on</strong>g>g procedures<br />

(Art. 20 of Commissi<strong>on</strong><br />

Regulati<strong>on</strong> (EC) 1234/2008)<br />

/ 1 st MA 100 % fee (<str<strong>on</strong>g>in</str<strong>on</strong>g> case of grouped<br />

variati<strong>on</strong>s tak<str<strong>on</strong>g>in</str<strong>on</strong>g>g <str<strong>on</strong>g>in</str<strong>on</strong>g>to account <str<strong>on</strong>g>the</str<strong>on</strong>g><br />

provisi<strong>on</strong>s for calculati<strong>on</strong> <strong>fees</strong> for grouped<br />

variati<strong>on</strong>s)<br />

1 st MA 100 % fee (<str<strong>on</strong>g>in</str<strong>on</strong>g> case of grouped<br />

variati<strong>on</strong>s tak<str<strong>on</strong>g>in</str<strong>on</strong>g>g <str<strong>on</strong>g>in</str<strong>on</strong>g>to account <str<strong>on</strong>g>the</str<strong>on</strong>g><br />

provisi<strong>on</strong>s for calculati<strong>on</strong> <strong>fees</strong> for grouped<br />

variati<strong>on</strong>s)<br />

Notificati<strong>on</strong> for product<br />

<str<strong>on</strong>g>in</str<strong>on</strong>g>formati<strong>on</strong> or labell<str<strong>on</strong>g>in</str<strong>on</strong>g>g<br />

amendment not c<strong>on</strong>nected<br />

<str<strong>on</strong>g>with</str<strong>on</strong>g> SPC<br />

20 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee<br />

+20 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each additi<strong>on</strong>al strength<br />

and/or pharmaceutical form<br />

Each additi<strong>on</strong>al MA 75 % fee of 1 st MA<br />

20 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee<br />

+20 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each additi<strong>on</strong>al strength<br />

and/or pharmaceutical form<br />

Each additi<strong>on</strong>al MA 75 % fee of 1 st MA<br />

20 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee<br />

+20 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each additi<strong>on</strong>al strength<br />

and/or pharmaceutical form<br />

Review of educati<strong>on</strong>al<br />

material<br />

70 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee*<br />

* no fee for additi<strong>on</strong>al strength and/or pharmaceutical form <str<strong>on</strong>g>in</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> same applicati<strong>on</strong><br />

4/7

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