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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).
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
Certificate of pharmaceutical product, a certificate which establishes the status of a pharmaceutical product; COPP (chemotherapy), a chemotherapy regimen for treatment of non-Hodgkin lymphoma; COPP (Combined Operations Pilotage Parties), a defunct British special military unit; Copps Coliseum, a sports and entertainment venue in Hamilton, Ontario
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
C++ (file extension: .cpp), a programming language; Carte parallelogrammatique projection, an equirectangular map projection; Chinese postman problem, a mathematical problem in graph theory; meta-Chlorophenylpiperazine, a chemical; Controllable-pitch propeller, is a type of propeller used in Marine propulsion.
Granted after an assessment of the documentation submitted by the applicant, a Certificate of Suitability (CEP) [18] provides proof that the methods used by a manufacturer or distributor result in an product whose quality complies with the requirements laid down in the corresponding Ph. Eur. monograph(s). The EDQM also runs an inspection ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.