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Showing 7431–7440 of 49500 articles for “Art. R 134-8 to R 134-11”
Advanced therapy medicinal products prepared on an ad hoc basis are distributed, under the responsibility of the person in charge referred to in article R. 4211-37 or, where applicable, the person in…
An authorised establishment or organisation may transfer to another authorised establishment or organisation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storag…
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as…
Any healthcare professional or any legal representative of a healthcare establishment, medico-social establishment or service or autonomous cosmetic surgery facility must declare without delay to the…
Medicinal products subject to compulsory prescription shall be provided with the unique identifier referred to in Article R. 5121-138-2, unless they are exempt from this requirement due to their prese…
All medicinal products are fitted with the tamper-evident device referred to in Article R. 5121-138-2. However, this device is not compulsory for medicinal products on the list set out in Annex I to C…
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…
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