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Showing 2581–2590 of 6831 articles for “Art. 11 mars 2021”
By way of derogation from the provisions of Article R. 5121-138, when the medicinal products or products are contained in an outer packaging that complies with the requirements of the said Article, th…
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…
…ct; 8° The batch number; 9° The expiry date in clear text; 10° Special storage precautions, if any; 11° Special precautions for disposal of unused products or waste derived from these products, if app…
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…
I.- In addition to the company's distinctive sign, the outer packaging may include signs or pictograms explaining some of the above information, as well as other information compatible with the summar…
Without prejudice to the provisions of Article R. 5132-15, the labelling of the immediate packaging and, if available, the outer packaging of the preparations mentioned in 1° to 3° of Article L. 5121-…
Ampoules or other small primary packaging on which it is impossible to include all the information provided for in Article R. 5121-146-2 may bear only the information provided for in a, c, d and h of…
For medicinal products containing radionuclides, in addition to the information provided for in article R. 5121-140, the labelling of the protective shielding provides all the explanations relating to…
…ise specified in the table below.APPLICABLE PROVISIONSAS THEY STANDIn Book IR. 2100-1 In Title IR. 2111-1 to R. 2111-2 R. 2111-4 to R. 2112-12 R. 2112-13 Resulting from Decree no. 2018-1225 of 24 Dece…
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