Statutory and Advisory Bodies » Public entities
Medicines Control Council
The Medicines Control Council is a statutory body that was established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 Of 1965) to oversee the regulation of medicines in South Africa. Its main purpose is to safeguard and protect the public by making sure that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.
The Council is mandated to:
- advise the minister on any matter referred by the minister or arise from the application of the Act
- keep the medicines register
- register new medicines
- amend entries in the register
- prohibit the sale of medicines not registered
- transfer certificates of registration
- cancel the registration of medicines
- approve medicine labels and advertisements
- authorise the sale of unregistered medicine for certain purposes.
The minister can determine and appoint members of the Council (not more than 24) as necessary.
The minister designates one of the council members as chairperson and another as vice-chairperson.
The Council may appoint an executive committee from among its members. The executive committee may (subject to directions of the Council) exercise all powers and perform all the functions of the Council between meetings of the Council.