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Showing 2601–2610 of 6499 articles for “Art. n° 11-11.115”
I.-The categories of magistral preparations that may be subcontracted by a dispensing pharmacy to a pharmaceutical establishment authorised to manufacture medicinal products are : 1° Preparations obta…
When a medicinal product is the subject of a marketing authorisation granted by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 200…
The information provided for in Articles R. 5121-138 and R. 5121-139 is written in French. They may also be written in other languages, provided that the same information appears in all the languages…
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…
Ampoules or other small primary packaging on which it is impossible to include all the information specified in Article R. 5121-138 may bear only the following information: 1° The name of the medicina…
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…
Without prejudice to the information required by other legislative and regulatory provisions, the labelling of the outer packaging or, where there is no outer packaging, the labelling of the immediate…
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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