GOVERNMENT NOTICE

DEPARTMENT OF HEALTH

No. R. 2003

MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965)

REGULATIONS RELATING TO FEES PAYABLE TO THE REGISTRAR

The Minister of Health has, in consultation with the Medicines Control Council, in terms of section 35(1) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), made the regulations in the Schedule.

SCHEDULE

Definitions

  1. In this Schedule "the Regulations" means the regulations published under Government Notice No. R 352 of 21 February 1975, as amended.

Fees

  1. The following fees shall be payable to the Registrar:

Category A medicines

(1) Human medicines, including Biologicals, compounded in its entirety in the RSA or not, for which an application for registration has been submitted as contemplated in section 15 of the Act-

(a) in respect of the submission of an application for registration of-

  1. new chemical entities or highly technological products, which have been processed by the abbreviated registration process (first strength, first dosage form): R30 000 per application;

  2. strengths and dosage forms other than those referred to in sub-paragraph (i): R15 000 per application;

  3. new chemical entities, including highly technological products, (first strength, first dosage form): R30 000 per application;

  4. Strengths and dosage forms other than those referred to in sub-paragraph (iii): R20 000 per application;

  5. Biological products (pharmaceutical, analytical and bioavailability evaluated): R30 000 per application;

  6. Generic products (pharmaceutical, analytical and bioavailability evaluated) and all other dental and radio pharmaceutical products (first strength, first dosage form): R12 500 per application;

  7. Strengths and dosage forms other than those referred to in sub-paragraph (vi): R6 500 per application;

(b) annually, in respect of the retention of the registration of a medicine, the registration of which has been approved by the Council in terms of section 15(3): R550: 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 Council 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 C medicines

(2) Veterinary medicines, including Biologicals, whether compounded in the RSA or not and for which Council has determined by resolution that such medicines are registrable-

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

  1. new chemical entities, including highly technological products, (first strength, first dosage form): R3 800 per application;
  2. Generic products (pharmaceutical, analytical and bioavailability evaluated): R3 800 per application;

(b) In respect of the registration of any medicine, the registration of which has been approved by the Council 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: R600 for each registration.

(c) Annually, in respect of the retention of the registration of a medicine, the registration of which has been approved by the Council in terms of Section 15(3): R350: Provided that this provision shall come into effect one year after the date on which the registration of such medicine was approved by the Council 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).

Amendment of entries in the register

(3) In respect of all applications for amendments in terms of Section 15A, the name of the medicine approved by the Council under section 15(5), which shall be the proprietary name, the approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the medicine, the conditions of registration, and the name of the applicant: R220 per application

Transfer of certificates of registration

(4) In respect of an application in terms of section 15B: registered name, approved name of every active ingredient and quantities thereof per dosage unit or per suitable mass or volume or unit of the medicine, dosage form, conditions under which the medicine is registered; and name of applicant: R400 per application.

Replacement of regulation 35 of the regulations

  1. These regulations replace regulation 35 of the regulations.

Commencement

  1. These regulations come into operation on 2 May 2003.


ME TSHABALALA-MSIMANG
MINISTER OF HEALTH