French Public Health CodeIn force
Subsection 2: Hearing and deliberation
Article R4234-27
Decisions are taken by the panel, by a majority of votes, without the parties being present.
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Showing 8031–8040 of 18481 articles for “Art. CE 5-5-2010 n° 301419”
Decisions are taken by the panel, by a majority of votes, without the parties being present.
The Chairman of the Disciplinary Board chairs the proceedings. He first gives the floor to the rapporteur to read his report. The chairman then gives the floor to the parties and, where appropriate, t…
…rawn up by the Chairman of the Disciplinary Board. The parties are summoned to the hearing. The notice to attend must be sent to the parties by any means that can be reliably dated at least fifteen da…
…e of the parties, after having obtained the opinion of the rapporteur where appropriate, prohibit access to the courtroom for all or part of the hearing in the interests of public order or where justi…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend…
…it has or becomes aware of which could lead to a change in the assessment of the risk-benefit balance of the medicinal product or product as defined in the first paragraph of Article L. 5121-9. It sh…
After a marketing authorisation has been granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may require the marketing authorisation holder to carr…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
…hin a period set by the Agency, the results of which will be used to reassess the benefit/risk balance of the medicinal product as defined in the first paragraph of article L. 5121-9 ; 2° It must be p…
…dverse reactions and in the periodic safety update reports, as well as any authorised variations since the initial authorisation or the previous renewal. The content of the dossier is laid down by ord…
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