Article R5211-5
For the purposes of this Title, the following definitions shall apply1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of…
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Showing 2121–2130 of 39773 articles for “Art. R. 145-5”
For the purposes of this Title, the following definitions shall apply1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of…
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
Before examining the application for assessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, addres…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall decide on the application within seven months of the date of receipt of the complete file. Failing…
When the acquisition, possession and supply of veterinary medicinal products by the groups provided for in the first paragraph of article L. 5143-6 are carried out under the supervision of a pharmacis…
Members of commissions, committees, working groups and other expert collegiate bodies, as well as external experts used by the Agency and appearing on a list drawn up by the Agency's Director General,…
The duties of a member of the Board of Directors are incompatible with those of a member of the Scientific Advisory Board.
In application of article L. 6111-1-6, healthcare establishments may offer their patients, on medical prescription from a practitioner practising within the establishment, a temporary non-medical acco…
Patients who are offered temporary accommodation are given full information about the characteristics of the accommodation, in particular the financial contribution that they and any accompanying pers…
Temporary non-medical accommodation may be offered to patients whose state of health does not justify continuous medical or paramedical supervision, hospitalisation at home or heavy technical medical…
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