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Showing 5481–5490 of 59899 articles for “Art. R 134-1”
I.-The outer packaging or, where there is no outer packaging, the immediate packaging of medicinal products bears safety features consisting of a unique identifier and a tamper-evident device, under t…
The safety features may only be replaced by equivalent safety features in order to verify the authenticity, identify and provide proof of unlawful handling of the medicinal product. This replacement i…
When a medicinal product is the subject of a reassessment of the risk-benefit balance, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform the…
In pharmaceutical establishments created within public establishments and non-profit organisations in application of article L. 5124-9-1, the legal representative of the legal entity concerned appoint…
I.-In order to benefit from a professional transition project, an intermittent employee in the live performance or recorded performance sectors must provide evidence of two hundred and eighty days' wo…
I. - The personal training account of the employee referred to in article L. 6323-11-1 who has worked at least half of the legal or contractual working time over the year is topped up by 800 euros for…
I. - The application for authorisation to carry out the stool collection activity provided for in Article L. 513-11-1 shall be sent to the Director General of the Agence nationale de sécurité du médic…
In order to obtain a marketing authorisation for a medicinal product which is not covered by the marketing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/…
The certificate of compliance with good practice relating to raw materials for pharmaceutical use is issued in accordance with Articles R. 5138-3 to R. 5138-6. When the inspection reveals serious brea…
The Agence nationale de sécurité du médicament et des produits de santé carries out an inspection of each blood establishment at least once every two years. The purpose of these inspections is to ensu…
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