ANSM Direction de l’inspection Pole Inspection des essais et des vigilances 143-147 boulevard Anatole France 93285 Saint Denis Cedex

The aforementioned Active Substance Master File holder hereby authorizes the ANSM, to refer to and review the above mentioned Active Substance Master File in support

D6 The management of the competences, skills and habilitations of the staff involved or likely to be involved in safety and/or MV cases is incomplete, considering the

D7.1 ‐ 31 st  December 2015  D7.2 ‐ 31 st  Decemeber 2015  D7.3 – 31 st  December 2015  D7.4 – 30 th  June 2015  D7.5 ‐ 30 th  June 2015  D7.6 ‐ 31

In response to point 3, a full review was completed on June 12, 2015 of AMED-002 Allergan Risk Management Process For Medical Devices and Combination Products, as well as the

D5 The management of the CAPAs/FSCAs by NAGOR Ltd is not completely satisfactory, which compromises the proper processing and notification of the serious incidents or risks of

It should be noted in this summary, the absence of a major European group: BIOTRONIK, for which the German competent authority, responsible for the implementation

In practice, most of the requests so far made to the Inspection Panel a llege th at the Bank has not followcd its environmental and social policies a nd

10 Among the most quoted, are the environment assessment policy, the indigenous peoples policy and the involuntary resettlement policy, as well as the policies