Marketing authorization may be suspended or revoked, for example in any of the following circumstances:

X The product has proved to be ineffective for the approved indication(s);
X It is strongly suspected that the product is unsafe in the normal conditions of use;
X The quantitative or qualitative composition is not as agreed in the marketing authorization;
X The product is not in compliance with the conditions of marketing authorization;
X The product is being promoted in an inappropriate or unethical manner.

For imported products, if marketing authorization is suspended or withdrawn in a country that supplied a WHO-type certificate, the marketing authorization holder should be asked to state why the authorization should not be suspended. The statement should address the quality, safety and efficacy of the product and GMP certification of the sites of manufacture.

In notifying the marketing authorization holder of any suspension or revocation of marketing authorization, the DRA should state the reasons for the decision and the appeal mechanisms available.