Regulations Governing Registration of Medicinal Products.

These Regulations, which are organized in 4 Chapters, have the purpose, established by Chapter 1, to enforce the legal framework to ensure effective and efficient registration of medicinal products, and to provide an open, transparent and non-discriminatory process for the registration of medicinal products. They cover human and veterinary medicinal products, vaccines and biological products for human and animal use, herbal medicinal products, disinfectant and antiseptics excluding cosmetics as well as laboratory and household chemicals.
The text regulates, in Chapter 2, the assessment and the registration of medicinal products, including many aspects inherent to the latter such as the application process, the requirements, documents and data necessary to this scope, the accountability of the applicant etc. It also concerns the conditional registration, the authorization for emergency use, the validity of registration, the variation of a registered medicinal product, its renewal, its suspension, its cancellation, its revocation. Also the labelling and package insert are treated here.
Chapter 3 covers the restrictions for sale of unregistered medicinal products. Miscellaneous provisions contained at Chapter 4, which include appeals and review, power to issue guidelines, offences and penalties, terminate the text.