Fees for human medicines
Expand a category below to see a breakdown of fees.
New applications
Complex dossier
| Type | Fee |
| National application | 23,700 |
| National application - each additional form (at the same time) | 8,925 |
| National application - each additional strength (at the same time) | 1,180 |
| Mutual recognition - CMS | 65,590 |
| Mutual recognition - CMS - each additional form (at the same time) | 5,925 |
| Mutual recognition - RMS Supplement | 17,770 |
| Outgoing MR Supplement 0 MRP applied for within 12 months of the national procedure ending | 17,770 |
| Additional Drug Master File submitted | 4,735 |
| Decentralised application - CMS | 23,700 |
| Decentralised application - RMS | 59,245 |
| Decentralised application CMS/RMS - each additional form | 8,295 |
| Decentralised application CMS/RMS - each additional strength | 1,180 |
| Decentralised / MR - additional RMS supplement where there are 15 or more concerned Member States | 1,780 |
Reduced dossier (complex)
| Type | Fee |
| National application | 17,770 |
| National application - each additional form (at the same time) | 8,295 |
| National application - each additional strength (at the same time) | 1,180 |
| Mutual recognition - CMS | 11,850 |
| Mutual recognition - CMS - each additional strength | 5,925 |
| Mutual recognition - RMS supplement | 1,180 |
| Outgoing MR Supplement - MRP applied for within 12 months of the national procedure ending | 4,735 |
| Additional Drug Master File submitted | 17,770 |
| Decentralised - CMS | 47,390 |
| Decentralised - RMS | 8,295 |
| Decentralised application CMS/RMS - each additional supplement where there are 15 or more concerned member stats | 1,180 |
| Decentralised / MR - additional RMS supplement where there are 15 or more concerned member states | 1,780 |
Reduced dossier (standard)
| Type | Fee |
| National application | 11,850 |
| National application - each additional form (at same time) | 8, 295 |
| National application - each additional strength (at same time) | 1,180 |
| Mutual recognition - CMS | 8,295 |
| Mutual recognition - CMS - each additional form | 4,735 |
| Mutual recognition - RMS supplement | 1,180 |
| Outgoing MR supplement - MRP applied for within 12 months of the national procedure ending | 11,850 |
| Additional Drug Master File submitted | 7, 110 |
| Decentralised application - CMS | 4, 735 |
Subsequent extension applications
| Type | Fee |
| National application - first additional form | 11,850 |
| National application - each additional form (at the same time) | 8,295 |
| National application - first additional strength (existing form) | 3,555 |
| National application - each additional strength (at the same time) | 1,180 |
| Mutual Recognition CMS - first additional form | 3,555 |
| Mutual Recognition CMS - first additional strength | 1,180 |
| Mutual Recognition CMS - subsequent additional strength | 11,850 |
| Mutual Recognition RMS supplement - each additional form | 30,805 |
| Mutual Recognition RMS supplement - each additional strength | 8,295 |
| Decentralised application CMS - first additional strength | 3,555 |
| Decentralised application CMS - first additional form | 8,295 |
| Decentralised application RMS - first additional form | 1,180 |
Switching applications
| Type | Fee |
| Switching applications | 6,045 |
Variations
National variations
| Type | Fee |
| Type IB variation - National | 610 |
| Type IB - National (reduced rate) | 310 |
| Type II Complex Variation - National | 3,395 |
| Type II Complex Variation - National (reduced rate) | 660 |
| Type II Standard Variation - National (reduced rate) | 660 |
| Type II Standard Variation - National | 330 |
| Type II Standard Variation - National (reduced rate) | 325 |
| Article 61 (3) Notifications - Directive 2001/83/EC - National | 165 |
Mutual recognition variations
| Type | Fee |
| Type IA Supplement - Mutual Recognition / Decentralised RMS | 325 |
| Type IB Variation - Mutual Recognition /Decentralised RMS Supplement | 450 |
| Type IB Variation - Mutual Recognition CMS | 440 |
| Type IB Variation - Mutual Recognition | 230 |
| Type II Complex Variation - Mutual Recognition CMS | 690 |