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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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Art. 13(1), Art. 13(3), Art. 13(4) of Directive 2001/82/EC 700 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 200 poong>inong>ts for each additional strength and/or pharmaceutical form 360 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 100 poong>inong>ts for each additional strength and/or pharmaceutical form 380 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 100 poong>inong>ts for each additional strength and/or pharmaceutical form 5000 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 1750 poong>inong>ts for each additional strength and/or pharmaceutical form 5800 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 1750 poong>inong>ts for each additional strength and/or pharmaceutical form Art. 13c of Directive 2001/82/EC 200 basic fee (1 strength associated ong>withong> 1 pharmaceutical form) 200 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) 200 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) 3500 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) 4600 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 200 poong>inong>ts for each additional strength and/or pharmaceutical form + 100 poong>inong>ts for each additional strength and/or pharmaceutical form + 100 poong>inong>ts for each additional strength and/or pharmaceutical form + 1750 poong>inong>ts for each additional strength and/or pharmaceutical form + 1750 poong>inong>ts for each additional strength and/or pharmaceutical form Long>inong>e Extension (Annex I to Commission Regulation (EC) 1234/2008) 600 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 200 poong>inong>ts for each additional strength and/or pharmaceutical form 250 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 100 poong>inong>ts for each additional strength and/or pharmaceutical form 280 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 100 poong>inong>ts for each additional strength and/or pharmaceutical form 3000 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 1750 poong>inong>ts for each additional strength and/or pharmaceutical form 3000 poong>inong>ts basic fee (1 strength associated ong>withong> 1 pharmaceutical form) + 1750 poong>inong>ts for each additional strength and/or pharmaceutical form 20% fee reduction for MUMS new applications. Type of application National procedure ong>RSong> as CMS (MRP/DCP) ong>RSong> as RMS (MRP/DCP) Type IA Variation (Art. 2 of 50 poong>inong>ts basic fee* 50 poong>inong>ts basic fee * 400 poong>inong>ts basic fee * 2/7

Commission Regulation (EC) 1234/2008) Type IB Variation (Art. 2 of Commission Regulation (EC) 1234/2008) Type II Variation ( ong>inong> ong>accordanceong> ong>withong> Art. 2 of Commission Regulation (EC) 1234/2008) 110 poong>inong>ts basic fee* 110 poong>inong>ts basic fee * 800 poong>inong>ts basic fee * 180 poong>inong>ts basic fee * 140 poong>inong>ts basic fee * 1300 poong>inong>ts basic fee * Grouped Variation (Art. 7(2), poong>inong>t (a) and ong>inong> conjunction ong>withong> Art. 8 of Commission Regulation (EC) 1234/2008) - annual variations 50 poong>inong>ts basic fee For each additional variation 75% of basic fee 50 poong>inong>ts basic fee For each additional variation 75% of basic fee 400 poong>inong>ts basic fee For each additional variation 75% of basic fee Grouped Variation (Art. 50 poong>inong>ts basic fee 7(2), poong>inong>t (a) of Commission Regulation (EC) For each additional variation 75% of 1234/2008) - type IA/IA IN Grouped Variation (Art. 7(2), poong>inong>t (b) of Commission Regulation (EC) 1234/2008) - Long>inong>e Extension as ong>theong> maong>inong> variation basic fee but not more than 400 poong>inong>ts 100 % basic fee for ong>theong> maong>inong> variation 75% of basic fee for each additional variation but not more than 1000 poong>inong>ts 50 poong>inong>ts basic fee For each additional variation 75% of basic fee but not more than 400 poong>inong>ts 100 % basic fee for ong>theong> maong>inong> variation 75% of basic fee for each additional variation but not more than 800 poong>inong>ts 400 poong>inong>ts basic fee For each additional variation 75% of basic fee but not more than 2000 poong>inong>ts 100 % basic fee for ong>theong> maong>inong> variation 75% of basic fee for each additional variation but not more than 5000 poong>inong>ts Grouped Variation (Art. 7(2), poong>inong>t (b) of Commission Regulation (EC) 1234/2008) – type II or type 100 % basic fee for ong>theong> maong>inong> variation 75% of basic fee for each additional variation but not more than 600 poong>inong>ts 100 % basic fee for ong>theong> maong>inong> variation 75% of basic fee for each additional variation but not more than 550 poong>inong>ts 100 % basic fee for ong>theong> maong>inong> variation 75% of basic fee for each additional variation but not more than 3000 poong>inong>ts 3/7

Art. 13(1), Art.<br />

13(3), Art. 13(4)<br />

of Directive<br />

2001/82/EC<br />

700 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 200 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

360 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

380 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

5000 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 1750 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

5800 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g> 1<br />

pharmaceutical form)<br />

+ 1750 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength and/or<br />

pharmaceutical form<br />

Art. 13c of<br />

Directive<br />

2001/82/EC<br />

200 basic fee (1 strength<br />

associated <str<strong>on</strong>g>with</str<strong>on</strong>g> 1<br />

pharmaceutical form)<br />

200 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

200 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g> 1<br />

pharmaceutical form)<br />

3500 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

4600 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g> 1<br />

pharmaceutical form)<br />

+ 200 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

+ 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

+ 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

+ 1750 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

+ 1750 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength and/or<br />

pharmaceutical form<br />

L<str<strong>on</strong>g>in</str<strong>on</strong>g>e Extensi<strong>on</strong><br />

(Annex I to<br />

Commissi<strong>on</strong><br />

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

1234/2008)<br />

600 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 200 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

250 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

280 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g> 1<br />

pharmaceutical form)<br />

+ 100 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

3000 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g><br />

1 pharmaceutical form)<br />

+ 1750 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength<br />

and/or pharmaceutical<br />

form<br />

3000 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee (1<br />

strength associated <str<strong>on</strong>g>with</str<strong>on</strong>g> 1<br />

pharmaceutical form)<br />

+ 1750 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts for each<br />

additi<strong>on</strong>al strength and/or<br />

pharmaceutical form<br />

20% fee reducti<strong>on</strong> for MUMS new applicati<strong>on</strong>s.<br />

Type of applicati<strong>on</strong> Nati<strong>on</strong>al procedure <str<strong>on</strong>g>RS</str<strong>on</strong>g> as CMS (MRP/DCP) <str<strong>on</strong>g>RS</str<strong>on</strong>g> as RMS (MRP/DCP)<br />

Type IA Variati<strong>on</strong> (Art. 2 of 50 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee* 50 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee * 400 po<str<strong>on</strong>g>in</str<strong>on</strong>g>ts basic fee *<br />

2/7

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