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Showing 6661–6670 of 38109 articles for “Art. R 418-6”
Pursuant to 1° of article L. 1334-15, in the event of non-compliance with the identification obligations defined in articles R. 1334-17 to R. 1334-19, to carry out dust measurements, to monitor the st…
I. - In application of 2° of article L. 1334-15, the Prefect may require a survey to be carried out, at the expense of the building owner, to check that the measures planned or implemented under the o…
The pharmacovigilance carried out on individually prepared advanced therapy medicinal products includes monitoring to ensure traceability between the various stages, from the removal of tissues, cells…
I.-Any establishment or body referred to in Article L. 4211-9-1 or any pharmaceutical establishment referred to in Articles L. 5124-1 or L. 5124-9-1 shall set up and keep up to date a system ensuring…
In the event of interruption or cessation of activity of an establishment or organisation mentioned in article L. 4211-9-1, the data relating to the traceability of advanced therapy medicinal products…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
The pharmacist removes the prescribed dosage units from the original outer packaging by any means that guarantees their integrity. He or she places them in a new outer packaging suitable for transport…
When dispensing a medicinal product by unit, the pharmacist provides the patient with a printed version of the package leaflet referred to in Article R. 5121-148. By way of derogation from the previou…
The specific arrangements for packaging, labelling and information for the insured party, as well as traceability for medicinal products dispensed individually in dispensing pharmacies, are set out in…
Without prejudice to the case where the number of units prescribed corresponds to the number of units appearing in an initial outer packaging that complies with the provisions of article R. 5121-138,…
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