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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

Regulations regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 2020

2. Fees

 

The following fees shall be payable to the Chief Executive Officer or the Director General as the case may be:

 

Category A medicines

 

Human medicines, including Biologicals, for which an application for registration is submitted as contemplated in Section 15 of the Act,

 

(a) In respect of the submission of an application for registration of—

 

(i) New Chemical Entities, including highly technological products,which have been processed by the abbreviated registration process [AMRP] (first strength,first dosage form): R111 000 per application;
(ii) Strengths and dosage forms other than those referred to in sub-paragraph (i): R 44 000 per application;
(iii) New Chemical Entities, new biotherapeutics other than vaccines (first strength, first dosage form): R208 400 per application;
(iv) Strengths and dosage forms other than those referred to in sub-paragraph (iii): R 82 000 per application;
(v) Biological products e.g. vaccines (excluding new biotherapeutics): R177 000 per application;
(vi) Biological products e.g. biosimilars (excluding new biotherapeutics): R173 000 per application;
(vii) Strengths and dosage forms other than ''those referred to in sub-paragraph (vi): R55 000 per application;
(viii) Generic products (pharmaceutical, analytical and bioavailability evaluated) including generic dental and radio-pharmaceutical products (first strength, first dosage form): R84 000 per application;
(ix) Strengths and dosage forms other than those referred to in sub-paragraph (vii): R27 000;
(x) Generic products with clinical data: R84 000;
(xi) Strengths and dosage forms other than those referred to in sub-paragraph (x): R27 000 per application;
(xii) Evaluation of additional submitted clinical data (pre-registration): R5 000; and
(xiii) An application in terms of Section 15C of the Act R37 800.

 

(b) Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act:
(i) In respect of registration of any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act (in the case of medicines in minute-dose form; the fee encompasses different dilutions and different volumes, when submitted simultaneously for the same indication or intended use) and in respect of which an application fee has been paid: R2 000 for each registration;
(ii) Evaluation of request for rescheduling of products: R16 000;
(iii) Evaluation of request to amend Professional Information and Patient Information Leaflets in respect of which data relating to safety must be evaluated (post registration); R15 600;

Evaluation of request to amend Professional Information and Patient Information Leaflets in respect of which clinical data relating to safety and efficacy must be evaluated (post registration): R15 600;

(iv) Evaluation of request to amend the Generic medicine package insert and Patient Information leaflet where clinical data are not required (post registration): R2 600;
(v) Evaluation of request for major technical amendments in respect of which data relating to quality must be evaluated (post registration) - Type II Level 1: R28 500;
(vi) Evaluation of request for major technical amendments in respect of which data relating to quality must be evaluated (post registration) - Type II Level 2: R 13 300;
(vii) Evaluation of request for major technical amendments in respect of which data relating to quality must be evaluated (post registration) - Type II Level 3: R4 400;
(viii) Evaluation of request for minor technical amendments in respect of which data relating to quality must be evaluated (post registration) - Type IA: R3 300;
(ix) Evaluation of request for minor technical amendments in respect of which data relating to quality must be evaluated (post registration) - Type 1B: R5 400;
(x) Evaluation of requests for approval of once-off deviations from registered requirements: R5 300;
(xi) Evaluation of requests for exemption from registered post-importation testing requirements per product: R5 300;
(xii) 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): R5 000: 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).

 

(c) In respect of the testing of a human vaccine for purposes of batch release by the National Control Laboratory: R23 100 per batch.

 

Category C medicines

 

Veterinary medicines, including Biologicals, for which Authority has determined by resolution that they are registerable:

 

(d) In respect of the submission of an application for registration of—
(i) New Chemical Entities, including highly technological products.

(first strength, first dosage form): R13 900 per application;

(ii) Generic products (pharmaceutical, analytical and

bioavailability evaluated): R12 700 per application;

(iii) Generic products with clinical data: R13 900;
(iv) Strengths and dosage forms other than those referred to in sub- paragraphs (i), (ii), (iii): R4 400;
(v) Screening fee on receipt of the application: R1 800;
(vi) Evaluation of additional submitted clinical data (pre-registration): R2 800.

 

(e) 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) (in the case of medicines in minute-dose forms; the fee encompasses different dilutions and different volumes, when submitted simultaneously for the same indication or intended use) and in respect of which an application fee has been paid: R1 800 for each registration;
(ii) Evaluation of request for rescheduling of products: R6 200;
(iii) Evaluation of request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated: R4 000;
(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): R2 300: 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).

 

Category D medicines (Human medicines)

 

Human medicines for which an application for registration has been submitted as contemplated in Section 15 of the Act,

(f) In respect of the submission of an application for registration of—
(i) Products submitted with clinical and or toxicological data (first strength, first dosage form): R14 300 per application;
(ii) Strengths and dosage forms other than those referred to in sub-paragraph (i): R4 500 per application;
(iii) Products submitted with no clinical or toxicology data (first strength, first dosage form): R6 400 per application;
(iv) Strengths and dosage forms other than those referred to in sub-paragraph (iii): R2 100;
(v) Screening fee on receipt of an application: R1 800;
(vi) Evaluation of additional submitted clinical data (pre-registration): R2 900; and
(vii) An application in terms of Section 15C of the Act: R34 700.
(g) Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act:
(i) In respect of registration of any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act and in respect of which an application fee has been paid: R1 800 for each registration;
(ii) Evaluation of request for rescheduling of products: R5 800;
(Iii) Evaluation of request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated (post- registration): R3 500;
(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 800: 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).

 

Category D medicines (Veterinary medicine)

 

Veterinary medicines for which Authority has determined by resolution that they are registerable:

(h) In respect of the submission of an application for registration of—
(i) Products submitted with clinical and or toxicological data, (first strength, first dosage form): R3 900 per application;
(ii) Products submitted with no clinical or toxicology data (first strength, first dosage form): R2 800 per application;
(iii) Strengths and dosage forms other than those referred to in sub-paragraphs (i), (ii): R1 600;
(iv) Screening fee on receipt of the application: R1 800;
(v) Evaluation of additional submitted clinical data (pre-registration): R1 500.
(i) 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 800 for each registration;
(ii) Evaluation of request for rescheduling of products: R5 800;
(iii) Evaluation of request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated: R3 500;
(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): R 1 300: 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).