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The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The warning letter includes the inspection dates and a description of the violating condition, practice, or product in brief but sufficient detail to provide the respondent the opportunity to correct the matter. It cites the section of the law and, where applicable, the regulation violated. Unlike the Form FDA 483, the warning letter cites ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Export Administration Regulations. The Export Administration Regulations (EAR) are a set of United States export guidelines and prohibitions. They are administered by the Bureau of Industry and Security, which regulates the export restrictions of sensitive goods. [1] The EAR apply to most U.S. origin items, foreign-produced items that ...
Phytosanitary certification verifies phytosanitary worthiness (plant health). These certificates are used to attest that consignments meet phytosanitary import requirements and are undertaken by a National Plant Protection Organization (NPPO). Under the Agreement on the Application of Sanitary and Phytosanitary Measures and ISPM, a certificate ...
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
In 2008, a logo very similar to CE marking was alleged to exist and to stand for China Export because some Chinese manufacturers apply it to their products. [22] However, the European Commission says that this is a misconception. [20] The matter was raised at the European Parliament in 2008. [23]
Marketing authorisation. Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal framework defining the requirements necessary for successful application to ...