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Showing 2361–2370 of 9599 articles for “Art. AMF Instruction-Position-Recommendation 2019-12”
Where the surface area of the construction within the meaning of 1° of article 1635 quater H and article 1635 quater I is greater than or equal to 5,000 square metres, the person liable for the develo…
The presence of an information leaflet for the user in the packaging of any medicinal product or product is compulsory, unless the information referred to in article R. 5121-149 appears directly on th…
The marketing authorisation holder must comply with the good package leaflet practices established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits…
The package leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their do…
Before adopting an act likely to be referred to the administrative court, local authorities or their groupings as well as their public establishments may refer to the State representative responsible…
The request for a formal position referred to in Article L. 1116-1 shall be sent to the State representative by any means that provides proof of receipt.
When the definitively adopted act is transmitted to the representative of the State or, where applicable, to the delegate in the district of the representative of the State in the department, as part…
The period referred to in the second paragraph of Article L. 1116-1 at the end of which the silence kept by the representative of the State is deemed to be the absence of a formal position runs from t…
The request for a formal position shall be in writing and signed by a person competent to represent the applicant. It shall include the draft act falling within the powers of the applicant and a clear…
The formal position statement shall be sent to the applicant by any means that provides proof of receipt.
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