Tag Archive | Medicines and Related Substances Amendment Act

Medicines Control South Africa

Medicines and Related Substances Bill tabled

MCC to go….

The parliamentary portfolio committee on health recently called for written comments on the recently tabled Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new entity called the South African Health Products Regulatory Agency (SAHPRA).

The new entity with a new body that will reflect better, the proposals suggest, the many facets and changes that have occurred in the industry.

The Bill also seeks to amend existing legislation to replace the word “products” with the word “medicines” and defines the expression “scheduled substances” in order to more correctly reflect what the anchor Act is in his view trying to achieve, the background to the Bill states.

Complementaries now included

It is also proposed that the minister of health and therefore the department (DoH) will have a far wider scope of regulatory control and the Bill also adds the expression ‘complementary medicines’ to its definitions.

The Bill has the intention, DoH says, of speeding up registration of medicines and will allow ‘mutual agreements’ with other worldwide drug registration institutions to enable the process of acceptance or rejection to take place. It is in this area that opinion from stakeholders is expected to be submitted.

A new body of committees made up of experts and specialists will assist DoH with such a process, the Bill says, but the decision making processes on the subject of registration of new drugs appears to be remaining a private matter within the department.

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