Article D6124-193
The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19.
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Showing 4111–4120 of 10952 articles for “Art. CJEU – Unamar – 17 Oct. 2013 – C-184/12”
The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19.
Where the site has an in-house pharmacy, the preparation of radiopharmaceuticals must be carried out under its supervision.
The provisions of paragraph 1 of sub-section 9, with the exception of those of II of article D. 6124-131, are applicable to the holder of a nuclear medicine qualification with grade B when carrying ou…
Staff working in the delimited area where radiopharmaceutical preparations and controls are carried out receive appropriate initial and ongoing training in radiopharmacy and radiation protection for s…
(first paragraph disjoined)Acquisitions and exchanges of real estate located in the heartlands of a national park made by the public establishment of this park are exempt from registration duties and…
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…
…e State or one of its public establishments pursuant to articles L. 2122-5 à L. 2122-14 and L. 2122-17 to L. 2122-19 of the General Code on the Ownership of Public Persons or Article 13 of Ordinance N…
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