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Showing 2511–2520 of 64163 articles for “Art. II-1°”
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…
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 chairman of the commission shall be elected by an absolute majority of the votes cast. If this election is not won after the first two rounds of voting, a third round shall be held and the electio…
The commission meets when convened by the chairman, either on his own initiative, or at the request of one-third of the members, or at the request of the prefect. The commission may only validly decid…
The term of office of a member of the commission ends when he loses the capacity in which he was called to sit. In the case of a departmental representative, the departmental council elects a replacem…
Moving parts for transmitting energy or for moving work equipment where there is a risk of mechanical contact which could lead to accidents are fitted with appropriate guards or devices to prevent acc…
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