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Subject: OPEN PART Доброго дня, коллеги!Помогите разобраться: РЕГИСТРАЦИОННОЕ ДОСЬЕ ПРЕПАРАТА ФОРМАТА ОТД Вот такие заголовки, но если open part, значит открытая часть, открытый допуск, а далее идет надпись Конфиденциально, получается противоречие или нет? |
| The scientific information in the APIMF should be physically divided into two separate parts, namely the Open Part (OP) and the Restricted Part (RP). The OP contains the information that the APIMF holder regards as non-confidential to the Applicant/PD holder, whereas the RP contains the information that the APIMF holder regards as confidential, see Annex 1. It is emphasized that the OP is still a confidential document that cannot be submitted by anyone to third parties without the written consent of the APIMF holder. In all cases the OP should contain sufficient information to enable the Applicant/PD holder to take full responsibility for an evaluation of the suitability of the specifications for the API to control the quality of this API for use in the manufacture of a specified FPP. http://apps.who.int/prequal/info_applicants/Guidelines/APIMF_Guide.pdf |
| Спасибо огромное!!! Век живи, век учись! :) |
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