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good distribution practices |
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| medicinal products & medical devices | ||
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MPI assists wholesalers and
international traders in development of their quality system for good
distribution practices. Once the system is set up, an adequate training programme is forseen MPI maintains and updates the system as required. MPI supervises on a regular basis the respect of the gdp guidelines (audits) |
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| legal basis | ||
| directive 2001/20/EC; | ||
| guidelines on good distribution practice of medicinal products for human use 94/C 63/3; | ||
| annex 13 to the directive 91/356/EEC 'Manufacture of Investigational Medicinal Products'. | ||