Article R5121-42
…produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited to…
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Showing 3741–3750 of 65989 articles for “Art. 505 al. 2 and al. 4”
…produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited to…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
Only health establishments providing the care mentioned in a of 1° of article L. 6111-2 may be authorised, in application of articles L. 6122-1 and L. 6122-2, to carry out care activities relating to…
In order to contribute to improving the safety of pregnancy, birth and the perinatal environment of the mother and child, health establishments practising obstetrics : 1° Participate in the management…
The neonatology unit provides round-the-clock surveillance and the specialised care mentioned in article R. 6123-41 every day of the year, whether or not newborn babies are born in the establishment.…
The neonatal intensive care unit provides the supervision and specialised care mentioned in article R. 6123-42 every day of the year, 24 hours a day, whether or not newborn babies are born in the esta…
The purpose of neonatology is to monitor and provide specialist care for at-risk newborns and those whose condition has deteriorated after birth.
Neonatal resuscitation is carried out in facilities authorised for this purpose. It can only be carried out if the health establishment includes an authorised neonatology unit on the same site, part o…
The purpose of neonatal resuscitation is to monitor and provide specialist care for newborns in serious distress or at vital risk.
…ith an establishment that does have such a unit. Any healthcare establishment practising obstetrics and treating identified high-risk maternal pregnancies must have an adult intensive care unit where…
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