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Showing 10631–10640 of 36632 articles for “Art. al. 5”
Any practice of prescribing a medicinal product outside the scope of its marketing authorisation may be reported by electronic means to the Director General of the Agency, to enable him to assess the…
…hdraw a compassionate access authorisation if the conditions laid down in I, II and V of Article L. 5121-12-1 or the provisions of this section are not complied with, or for any other public health re…
The labelling of the medicinal products mentioned in II of article L. 5121-12-1 includes at least the following information: 1° The name of the medicinal product or, where appropriate, its code name o…
…icinal 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 the co…
…ing of a unique identifier and a tamper-evident device, under the conditions set out in articles R. 5121-138-1 and R. 5121-138-3. II.-The unique identifier allows persons whose activity is the wholesa…
I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State pa…
When registration is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are…
The Director General of the Agency will take a decision within two hundred and ten days of the submission of a complete application. He may ask the applicant, in a letter stating the reasons for the r…
…eons or midwives who do not practice in an establishment, service or centre mentioned in article R. 5121-88 or who do not meet the conditions set out in article R. 5121-91 may be authorised to adminis…
Classification as a medicinal product requiring special monitoring during treatment can only be made if the restrictions on prescribing the medicinal product are justified by the seriousness of the un…
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