Plant Breeders' Rights Act, 1976
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 20256. Category D medicines (Veterinary medicines) |
Veterinary medicines for which Authority has determined by resolution that they are registerable:
(a) In respect of the submission of an application for registration of:
(i) Products submitted with clinical and or toxicological data, (first strength and dosage form) per application: R5 900,
(ii) Products submitted with no clinical or toxicology data (first strength and dosage form) per application: R4 800,
(iii) Strengths and dosage forms other than those referred to in sub-paragraphs (i), (ii) per application: R3 500 and
(iv) Evaluation of additional submitted clinical data (pre-registration) per application: R1 600.
| (b) | Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3): |
| (i) | In respect of the registration of any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) and in respect of which an application fee has been paid: R1 900 for each registration, |
| (ii) | Evaluation of request for rescheduling of products per product registered: R6 000, |
| (iii) | Evaluation of request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated per application: R3 600, |
| (iv) | Annually, in respect of the retention of the registration of a medicine, the registration of which has been approved by the Authority in terms of Section 15(3): R1 400: Provided that this provision shall come into effect one year after the date on which the registration of the said medicine was approved by the Authority in terms of Section 15(3): Provided further that the said fees payable during a particular calendar year shall be payable on or before the last working day of June that year, failing which the registration may be cancelled in terms of Section 16(4) and |
| (v) | Evaluation of medicine proprietary name changes (post registration) per application: R3 400. |
