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Article R4211-53 of the French Public Health Code

The provisions of this section apply to health establishments which hold the authorisation referred to in Article L. 1243-2 and which meet the conditions for obtaining the authorisation provided for in Article L. 4211-9-2 to carry out, in the context of the research referred to in the first paragraph of Article L. 1121-1, the activities of manufacturing, importing, exporting and distributing advanced therapy medicinal products as defined in Article 2…

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