Building on existing Drug Regulatory Authorities 3. This should always be done for products manufactured in the country. The DRA should then require that applicants submit a Certificate of a Pharmaceutical Product.
Many countries have a limited registration period, usually five years.
At the end of the period, an application for renewal of registration has to be submitted with or without supplementary documentation on the product if the manufacturer or importer wants to continue to have the product on the market. The DRA usually has a drug evaluation committee with appropriate scientific expertise, either an advisory or a decision-making body. A licence issued by the DRA should be required for production of any medicinal products. Manufacturers should be inspected before and regularly after licensing to ensure that their facilities and procedures comply with national or international GMP guidelines or other consonant requirements. This is the basis for preparing prescribing and patient information.