Homeopathic National Rules Scheme and Simplified Registration Scheme fees
These are the proposed amendments to the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994.
The UK introduced a new National Rules Scheme for homeopathic medicinal products under Article 16.2 of Directive 2001/83, which started on 1 September 2006. Products are required to meet particular standards on safety, quality and patient information.
| Homeopathic National Rules Scheme |
Fee £
|
Fee £
|
|---|---|---|
|
5 or fewer stocks
|
More than 5 stocks
|
|
| Standard |
1,176
|
1,418
|
| Reduced: | ||
| Stock already assessed |
874
|
1,096
|
| Formulation already assessed |
874
|
1,096
|
| Both stock and formulation already assessed |
558
|
791
|
| Supplementary fees |
Fee £ |
|
| New method of sterilisation (non-pharmacopoeial) |
2,328
|
|
| New excipients |
7,766
|
|
| New sources TSE risk actives/excipients (non-CEP) |
686
|
|
| Simplified Homeopathic Registration Scheme | ||
|
5 or fewer stocks
|
More than 5 stocks
|
|
| Standard |
854
|
1,118
|
| Reduced: | ||
| Stock already assessed |
517
|
761
|
| Formulation already assessed |
517
|
761
|
| Both stock and formulation already assessed |
172
|
425
|
| Simplified Homeopathic Registration Scheme Mutual Recognition Procedures | ||
| Mutual recognition outgoing |
5 or fewer stocks
|
More than 5 stocks
|
|
310
|
405
|
|
| Mutual recognition incoming |
5 or fewer stocks
|
More than 5 stocks
|
|
542
|
690
|
|
| Homeopathic variations | ||
| Homeopathic Simplified Scheme |
New technical
|
263
|
|
Other
|
133
|
|
| Homeopathic National Rules Scheme |
New technical
|
263
|
|
Indication
|
405
|
|
|
Other
|
133
|
|
|
Note: For variations to homoeopathic medicinal products registered under the Simplified Scheme or authorised under the National Rules Scheme, a bulk “discount” applies where a number of simultaneous applications are made for identical variations. In general, the first of those applications is charged at the full rate shown above and the second and subsequent applications, up to 30 variations, are charged at 50%. Subsequent simultaneous applications for identical variations are charged at 25% of the full rate shown. *Fees relating to Homoeopathic Manufacturers’ licences and Wholesale Dealers’ licences applications and annual periodic fees - see tables elsewhere. |
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