Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

For the medicinal products mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are carried out in accordance with the procedures set out in the therapeutic use protocol.

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 the European Commission.

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: 1° Any serious adverse reaction suspected to be due to the allergens he has prepared and supplied, of which he is aware, without delay and no later than fifteen days following receipt of the information; 2°…

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 preparation activities, are subject to the provisions of articles R. 5121-162, R. 5121-163 with the exception of 4°, R. 5121-164 with the exception of 3° and 5° and R. 5121-165. They report electronically to the European “Eudravigilance” database: 1° Any serious adverse reaction suspected to be…

The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a report summarising the information relating to the adverse reactions which they have reported or which have been reported to them and all the information useful for assessing the risks and benefits associated with the use of the hospital…

The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.