E-drug: Relation DRA - Minister of Health
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Dear E-druggers,
There is a debate in South Africa about the relation of the Drug Regulatory
Authority and the Minister of Health. The DRA is an autonomous body, and
its members are appointed by the Minister.
Could E-druggers tell how the situation is in their own countries,
especially on the following questions:
1. Is a decision by the DRA on the registration of a product a final
decision (that cannot be changed by the Minister) or is it a recommendation
(that is normally approved by the Minister but the Minister has the right
not to accept the recommendation (stalemate) or does the Minister even have
the right to change the recommendation and take an opposite decision?.
2. How is new drug legislation made?
In the case of making Regulations (part of drug legislation):
After consultation between DRA and Minister the DRA makes a draft
(recommendation) which is then signed by the Minister (decision), published
for comments and becomes legislation.
Now what happens if DRA and Minister disagree? Does this mean stalemate (no
decision can be made) or can the Minister make Regulations without a
recommendation by the DRA?
Please give also the name of your Act in your reply.
I will collect the examples and feedback the info to the list.
Thanks a lot for your assistance!
Wilbert Bannenberg
South Africa
Email: 73377.3055@compuserve.com
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