Regulation of the Minister of Health of the Republic of Indonesia concerning guidelines for implementation of opioid replacement therapy program
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
more
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
A survey of prevention, testing and treatment policies and practices
Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Prices people pay for medicines.