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Showing 101–110 of 475 articles for “Art. 150 UB”
The holder of the authorisation provided for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé…
…company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about this m…
…ure laid down in 1° of Articles R. 5121-26 and R. 5121-28 and in Article R. 5121-97 is required to submit a periodic safety update report: 1° Under the conditions determined by the marketing authorisa…
…uncil, that the marketing authorisation should be varied, the marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de s…
…ny company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety update…
…in order to request the setting of European Union reference dates or a change in the frequency of submission of periodic safety update reports, for reasons of public health, in order to avoid duplica…
Pharmaceutical establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparati…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
…ny company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluatio…
…the use of the hospital preparations and magistral preparations which they make or which they have subcontracted.
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