Examples of using Presented in module in English and their translations into Slovenian
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Financial
-
Computer
-
Official/political
-
Programming
Presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the MedicinalMarketing Authoris tion is in place and functioning before and whilst the medicinal product is on the market.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan,as agreed in Version 5 of the Risk Management Plan(RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the marketing authorisation, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18April 2006 of the Risk Management Plan(RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Dated 17 January 2008 of the Risk Management Plan(RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan,as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
The MAH shallperform the pharmacovigilance activities as agreed in the RMP presented in Module of the Marketing Authorisation and any subsequent updates.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
The MAH shall perform the required pharmacovigilance activities andinterventions detailed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
The MAH must ensure that the system of pharmacovigilance,as described in version 2.0 presented in Module of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan andthe Efficacy Follow-up Plan as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use(CHMP).
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance,as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.