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Showing 9001–9010 of 63908 articles for “Art. I-1°”
Persons implementing the techniques referred to in article R. 1311-1 must have undergone training in the hygiene and health conditions provided for in article R. 1311-4. An order by the Minister for H…
The authorisation provided for in article L. 4211-6 may be renewed at the request of the holder, submitted no later than three months before the expiry date. This application for renewal must include…
The authorisation may be amended ex officio, suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé where it appears : 1° That one or…
Any changes to the information and documents mentioned in Article R. 4211-1 must be authorised by the Director General of the Agency. The application for authorisation must be accompanied by the corre…
As soon as the request is received, the Director General of the Agency will refer the matter to the Académie nationale de médecine for an opinion. In the absence of a response within sixty days of the…
The authorisation is issued for a period of five years and is renewable under the conditions set out in article R. 4211-9. It mentions the surname, first name and position of the person preparing and…
After the authorisation provided for in Article L. 4211-6 has been issued, the manufacturing and preparation methods and the control techniques mentioned in 5° and 6° of Article R. 4211-1 are modified…
If the Director General of the Agency does not respond to an application for authorisation within six months of the submission of a complete and regular application, this will be deemed to constitute…
The authorisation holder shall inform the Director General of the Agency of the date of commencement of the allergen preparation and supply activity. He shall also inform him of the definitive cessati…
I.-Pursuant to the provisions of 3° of Article 706-25-9, the authorities, agents or services mentioned in II may directly query the file, via a secure electronic communication system, based solely on…
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