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Diagnostic Agents

 
INFORMATION FOR OPTOMETRISTS TO APPLY FOR A CONCESSION IN TERMS OF SECTION  22A(12) OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965 (ACT 101 OF 1965).
The Act guiding the actions by optometrists has been changed to allow the use of diagnostic medicines in their practices. The rendering of these services is however not possible within the current legislation as optometrists do not have access to scheduled medicines. New legislation acknowledging optometrists as prescribers is not in place yet.
The requirements of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1955) must, however, be complied with. It is therefore necessary to issue section 22A(12) permits in terms of the Act to allow optometrists access to scheduled medicines. 

CRITERIA FOR APPLICATION:
An optometrist may apply for a concession.
In the case of a health care professional, the relevant Statutory Council should confirm that the particular professional is competent to acquire, possess, use or supply medicines, prior to such a permit being issued.
Notwithstanding the provisions of Section 22A(12), the applicant must conform to all the applicable requirements of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) as well as the maintenance of standards of practice.
The permit will be valid for 12 months from the date of issue. Applications for renewal should reach the Director-General; Health 3 months prior to expiry and will be subject to reconsideration on application for renewal
In the case of a health care professional, the relevant Statutory Councils should confirm that the particular professional is registered to practice.
Certificate of Advanced Study (CAS) as proof of competency is a prerequisite.

ANNEXURE
This is an annexure to the permit issued in terms of Section 22A ( 15) of Act 101 of 1965 for the following scheduled medicines which are required for the rendering of OPTOMETRY SERVICES: 

Herewith the list:
Local Anaesthetics 
a) Oxybuprocaine
b) Proparacaine

Mydriatics 
a) Tropicamide
b) Cyclopentolate HCL
c) Atropine 1%
d) Homatropine HBr 2%

Miotics
a) Pilocarpine

MINIMS OR SINGLE USE EYEDROPS MUST BE USED AT ALL TIMES. ALL OPENED BOTTLES MUST BE USED WITHIN 30 DAYS OR DISCARDED
To download the application form for a permit for diagnostic agents, click here.

List of Pharmaceutical agents

APPLICATION PROCESS:
An optometrist wanting to apply for a concession should obtain an application form from the Directorate:

Pharmaceutical Programmes and Planning at the National Department of Health at the following address:
The Director-General
Department of Health
Private Bag X828
PRETORIA
0001

Attention: Directorate: Pharmaceutical Programmes and Planning

ENQUIRIES
Salebo Phaahle
Affordable Medicines
Licensing Unit
Tel: 012 395 8214
Fax: 086 590 0339 / 012 395 8824
Email: phaahm@health.gov.za