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Showing 6071–6080 of 56727 articles for “Art. Cass. 3e Civ. 10-1-1990 n° 83”
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…
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…
Pharmacovigilance is carried out :1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been i…
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…
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…
The information contained in advertising for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therape…
For the purposes of this chapter, the following definitions shall apply 1° "Adverse reaction": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150…
Pharmacovigilance includes: 1° The reporting of adverse reactions suspected to be due to a medicinal product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse a…
The duration of the practical experience provided for in article R. 5124-16 is reduced to one year for pharmacists whose studies were carried out under a five-year system. It is reduced to six months…
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