ASN Report 2015

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2.7.1 The National Agency for the Safety
of Medication and Health Products
The National Agency for the Safety of Medication and
Health Products (ANSM) was created on 1st May 2012.
The ANSM, a public body reporting to the Ministry
of Health, has taken up the duties of the AFSSAPS
alongside other new responsibilities. Its key role is to
offer patients equitable access to innovation and to
guarantee the safety of health products throughout their
life cycle, from initial testing through to monitoring
after receiving marketing authorisation.
The Agency and its activities are presented on its website:
. The ASN-ANSM convention was
renewed on 2nd September 2013.
2.7.2 French National Authority for Health
The French National Authority for Health (HAS), an
independent administrative authority createdby theFrench
Government in2004, is taskedprimarilywithmaintaining
anequitablehealth systemandwith improvingpatient care.
The Authority and its activities are presented on its
website An ASN-HAS convention was
signed on 4th December 2008.
2.7.3 French National Cancer Institute
Created in 2004, the French National Cancer Institute
(INCa) is primarily responsible for coordinating activities
in the fight against cancer.
TABLE 1: Advisory Committee meetings and visits in 2015
GPE MAIN TOPIC DATE
GPR Informing EDF about the in-depth analysis of the event 8th January
GPMED Conditions for Implementation of “New Techniques and Practices” in Radiotherapy 10th February
GPR Management of activities subcontracted by EDF in PWRs in operation 11th February
GPRADE Protection of non-human species and information about the work of the “Worker radiological surveillance” WG 13th February
GPR Progress of the Flamanville 3 worksite and preparation for assessment of the commissioning authorisation application 5th March
GPU Periodic safety review of the UP3 A plant (BNI 116) at La Hague operated by Areva NC (4th session: update of safety analyses) 18th March
GPR Safety review guidelines associated with the fourth ten-yearly inspections of the 900 MWe reactors (VD4 900) 1st and 2nd April
GPT New regulation cycle 23rd April
GPMED Changes to Diagnostic Reference Levels 26th May
GPR Visit to an EDF simulator at the CNEN in preparation for the GP of 18th June 3rd June
GPRADE "Leukaemia risks and exposure to ionising radiation" seminar 9th June
GPESPN Orientations chosen by EDF for updating of the regulation reference files for the fourth ten-yearly inspections of the 900 MWe reactors and continued
operation up to VD4 + 20 years 10th June
GPR Optimisation of radiation protection in EDF nuclear power plants 11th June
GPR EPR project – Flamanville 3 – Review of organisational, human and technical resources for operation of the EPR reactor 18th June
GPU/GPD Update of the EDF decommissioning strategy – 2013 30th June
GPU/GPD EDF Waste management strategy 1st July
GPMED Alpha therapy and imaging action plan 15th September
GPD Meeting between the GPD and its German counterpart in Germany 14th and 16th September
GPESPN In-service strength of 1,300 MWe reactors during the ten-year period following VD3 24th September
GPRADE New internal regulations, protection of non-human species and transposition of Directive 2013/59/Euratom 25th September
GPR Information meeting on the seismic hazard assessment made for the PWR "hardened safety core" 29th September
GPESPN Analysis of the approach proposed by Areva to demonstrate the adequate toughness of the Flamanville 3 EPR vessel bottom head
and vessel closure head domes. 30th September
GPR EPR: examination of level 2 probabilistic safety assessments (PSA 2) and severe accidents (AG) for the Flamanville 3 reactor 15th October
GPRADE Approval of the new internal regulations, discharge of radionuclides into the sewer networks, update of the Labour Code and information 26th November
84 CHAPTER 02: PRINCIPLES AND STAKEHOLDERS IN THE REGULATION OF NUCLEAR SAFETY AND RADIATION PROTECTION
ASN report on the state of nuclear safety and radiation protection in France in 2015