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

Explanatory notes:
- 1 po<strong>in</strong>t is 5 Eur
Medic<strong>in</strong>al Products for Veter<strong>in</strong>ary Use
Type of
application
Art. 12(3),
Art. 13b of
Directive
2001/82/EC
Art. 13a of
Directive
2001/82/EC
National procedure <strong>RS</strong> as CMS (MRP) <strong>RS</strong> as CMS (DCP) <strong>RS</strong> as RMS (MRP) <strong>RS</strong> as RMS (DCP)
1000 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
+ 200 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
800 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
420 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
+ 100 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
380 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
450 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
+ 100 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
420 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
6000 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
+ 1750 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
5000 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong>
1 pharmaceutical form)
7000 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong> 1
pharmaceutical form)
+ 1750 po<strong>in</strong>ts for each
additional strength and/or
pharmaceutical form
5500 po<strong>in</strong>ts basic fee (1
strength associated <strong>with</strong> 1
pharmaceutical form)
+ 200 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
+ 100 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
+ 100 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
+ 1750 po<strong>in</strong>ts for each
additional strength
and/or pharmaceutical
form
+ 1750 po<strong>in</strong>ts for each
additional strength and/or
pharmaceutical form
1/7

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

Commission Regulation (EC)
1234/2008)
Type IB Variation (Art. 2 of
Commission Regulation (EC)
1234/2008)
Type II Variation ( <strong>in</strong>
<strong>accordance</strong> <strong>with</strong> Art. 2 of
Commission Regulation (EC)
1234/2008)
110 po<strong>in</strong>ts basic fee* 110 po<strong>in</strong>ts basic fee * 800 po<strong>in</strong>ts basic fee *
180 po<strong>in</strong>ts basic fee * 140 po<strong>in</strong>ts basic fee * 1300 po<strong>in</strong>ts basic fee *
Grouped Variation (Art.
7(2), po<strong>in</strong>t (a) and <strong>in</strong>
conjunction <strong>with</strong> Art. 8 of
Commission Regulation (EC)
1234/2008) - annual
variations
50 po<strong>in</strong>ts basic fee
For each additional variation 75% of
basic fee
50 po<strong>in</strong>ts basic fee
For each additional variation 75% of basic
fee
400 po<strong>in</strong>ts basic fee
For each additional variation 75% of basic
fee
Grouped Variation (Art. 50 po<strong>in</strong>ts basic fee
7(2), po<strong>in</strong>t (a) of
Commission Regulation (EC) For each additional variation 75% of
1234/2008) - type IA/IA IN
Grouped Variation (Art.
7(2), po<strong>in</strong>t (b) of
Commission Regulation (EC)
1234/2008) - L<strong>in</strong>e Extension
as <strong>the</strong> ma<strong>in</strong> variation
basic fee but not more than 400 po<strong>in</strong>ts
100 % basic fee for <strong>the</strong> ma<strong>in</strong> variation
75% of basic fee for each additional
variation but not more than 1000
po<strong>in</strong>ts
50 po<strong>in</strong>ts basic fee
For each additional variation 75% of basic
fee but not more than 400 po<strong>in</strong>ts
100 % basic fee for <strong>the</strong> ma<strong>in</strong> variation
75% of basic fee for each additional
variation but not more than 800 po<strong>in</strong>ts
400 po<strong>in</strong>ts basic fee
For each additional variation 75% of basic
fee but not more than 2000 po<strong>in</strong>ts
100 % basic fee for <strong>the</strong> ma<strong>in</strong> variation
75% of basic fee for each additional
variation but not more than 5000 po<strong>in</strong>ts
Grouped Variation (Art.
7(2), po<strong>in</strong>t (b) of
Commission Regulation (EC)
1234/2008) – type II or type
100 % basic fee for <strong>the</strong> ma<strong>in</strong> variation
75% of basic fee for each additional
variation but not more than 600 po<strong>in</strong>ts
100 % basic fee for <strong>the</strong> ma<strong>in</strong> variation
75% of basic fee for each additional
variation but not more than 550 po<strong>in</strong>ts
100 % basic fee for <strong>the</strong> ma<strong>in</strong> variation
75% of basic fee for each additional
variation but not more than 3000 po<strong>in</strong>ts
3/7

IB as <strong>the</strong> ma<strong>in</strong> variation
Exemption: variation to
change <strong>the</strong> name and/or
address of <strong>the</strong> MAH or
variation to changes to an
exist<strong>in</strong>g pharmacovigilance
system as described <strong>in</strong> <strong>the</strong>
DDPS
Exemption: variation to
change (<strong>in</strong>vented) name of
<strong>the</strong> medic<strong>in</strong>al product <strong>in</strong>
one or more MS (<strong>in</strong>clud<strong>in</strong>g
<strong>in</strong> Slovenia)
Up to 20 medic<strong>in</strong>al products: 100 po<strong>in</strong>ts
More than 20 medic<strong>in</strong>al products: 200
po<strong>in</strong>ts
Up to 20 medic<strong>in</strong>al products: 100 po<strong>in</strong>ts
More than 20 medic<strong>in</strong>al products: 200
po<strong>in</strong>ts
Up to 20 medic<strong>in</strong>al products: 100 po<strong>in</strong>ts
More than 20 medic<strong>in</strong>al products: 200
po<strong>in</strong>ts
More than 50 medic<strong>in</strong>al products: 400 More than 50 medic<strong>in</strong>al products: 400 More than 50 medic<strong>in</strong>al products: 400
po<strong>in</strong>ts
po<strong>in</strong>ts
po<strong>in</strong>ts
/ 110 po<strong>in</strong>ts basic fee 800 po<strong>in</strong>ts basic fee
Workshar<strong>in</strong>g procedures
(Art. 20 of Commission
Regulation (EC) 1234/2008)
/ 1 st MA 100 % fee (<strong>in</strong> case of grouped
variations tak<strong>in</strong>g <strong>in</strong>to account <strong>the</strong>
provisions for calculation fees for grouped
variations)
1 st MA 100 % fee (<strong>in</strong> case of grouped
variations tak<strong>in</strong>g <strong>in</strong>to account <strong>the</strong>
provisions for calculation fees for grouped
variations)
Notification for product
<strong>in</strong>formation or labell<strong>in</strong>g
amendment not connected
<strong>with</strong> SPC
20 po<strong>in</strong>ts basic fee
+20 po<strong>in</strong>ts for each additional strength
and/or pharmaceutical form
Each additional MA 75 % fee of 1 st MA
20 po<strong>in</strong>ts basic fee
+20 po<strong>in</strong>ts for each additional strength
and/or pharmaceutical form
Each additional MA 75 % fee of 1 st MA
20 po<strong>in</strong>ts basic fee
+20 po<strong>in</strong>ts for each additional strength
and/or pharmaceutical form
Review of educational
material
70 po<strong>in</strong>ts basic fee*
* no fee for additional strength and/or pharmaceutical form <strong>in</strong> <strong>the</strong> same application
4/7

Type of application National procedure <strong>RS</strong> as CMS (MRP/DCP) <strong>RS</strong> as RMS (MRP/DCP)
Renewal
300 po<strong>in</strong>ts basic fee (1 strength
associated <strong>with</strong> 1 pharmaceutical form)
250 po<strong>in</strong>ts basic fee (1 strength associated
<strong>with</strong> 1 pharmaceutical form)
2350 po<strong>in</strong>ts basic fee (1 strength
associated <strong>with</strong> 1 pharmaceutical form)
+ 50 po<strong>in</strong>ts for each additional strength
and/or pharmaceutical form
+ 50 po<strong>in</strong>ts for each additional strength
and/or pharmaceutical form
+ 500 po<strong>in</strong>ts for each additional strength
and/or pharmaceutical form
PSUR assessment 300 po<strong>in</strong>ts 50 po<strong>in</strong>ts 2350 po<strong>in</strong>ts
Type of application
National procedure
Transfer of MA
Cessation of validity of MA
50 po<strong>in</strong>ts basic fee (1 strength associated <strong>with</strong> 1 pharmaceutical form)
+ 50 po<strong>in</strong>ts for each additional strength and/or pharmaceutical form but not more than
200 po<strong>in</strong>ts
20 po<strong>in</strong>ts basic fee (1 strength associated <strong>with</strong> 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 po<strong>in</strong>ts
300 po<strong>in</strong>ts
700 po<strong>in</strong>ts
5/7

Type of application
National procedure
Change of classification of OTC medic<strong>in</strong>al product concern<strong>in</strong>g <strong>the</strong> place
of dispens<strong>in</strong>g
Classification of product as medic<strong>in</strong>al product
100 po<strong>in</strong>ts
60 po<strong>in</strong>ts
Additional provisions for homeopatic veter<strong>in</strong>ary products
Type of
application
Art. 16 of
Directive
2001/82/EC
National procedure <strong>RS</strong> as CMS (MRP/DCP) <strong>RS</strong> as RMS (MRP) <strong>RS</strong> as RMS (DCP)
100 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong> 1
homeopathic pr<strong>in</strong>ciple,
associated <strong>with</strong> 1 pharmaceutical
form)
50 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong> up
to 3 homeopathic pr<strong>in</strong>ciples,
associated <strong>with</strong> 1 pharmaceutical
form)
4000 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong> up
to 3 homeopathic pr<strong>in</strong>ciples,
associated <strong>with</strong> 1 pharmaceutical
form)
4000 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong> up
to 3 homeopathic pr<strong>in</strong>ciples,
associated <strong>with</strong> 1
pharmaceutical form)
300 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong> 2 to
3 homeopathic pr<strong>in</strong>ciples,
associated <strong>with</strong> 1 pharmaceutical
form)
400 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong>
more than 3 homeopathic
pr<strong>in</strong>ciples associated <strong>with</strong> 1
pharmaceutical form)
60 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong>
more than 3 homeopathic
pr<strong>in</strong>ciples associated <strong>with</strong> 1
pharmaceutical form)
4400 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong>
more than 3 homeopathic
pr<strong>in</strong>ciples associated <strong>with</strong> 1
pharmaceutical form)
4400 po<strong>in</strong>ts basic fee (for
homeopathic medic<strong>in</strong>es <strong>with</strong>
more than 3 homeopathic
pr<strong>in</strong>ciples associated <strong>with</strong> 1
pharmaceutical form)
6/7

+ 60 po<strong>in</strong>ts for each additional
pharmaceutical form
+ 20 po<strong>in</strong>ts for each additional
pharmaceutical form
+ 1750 po<strong>in</strong>ts for each additional
pharmaceutical form
+ 1750 po<strong>in</strong>ts for each
additional pharmaceutical form
Type of
application
Type IA, IB, II
Variation
Renewal
National procedure <strong>RS</strong> as CMS (MRP/DCP) <strong>RS</strong> as RMS (MRP/DCP)
30 po<strong>in</strong>ts basic fee 30 po<strong>in</strong>ts basic fee 1000 po<strong>in</strong>ts basic fee
30 po<strong>in</strong>ts basic fee for each pharmaceutical
form
30 po<strong>in</strong>ts basic fee for each pharmaceutical
form
1000 po<strong>in</strong>ts basic fee for each pharmaceutical
form
7/7