French ANSM Clarifies Guidance Related To Raw Materials For Pharmaceutical Use

Author:Ms Maureen Bennett, Christian Fulda, Colleen Heisey, Cristiana Spontoni, Armelle Sandrin-Deforge, Indradeep Bhattacharya, Michele R. Goodman, Elinor Pecsteen, Marina E. Moreno and Tamara Senikidze
Profession:Jones Day
 
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On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for pharmaceutical use ("RMPU"). In particular, the ANSM clarified the scope of the authorization/declaration procedure; only facilities that are located in French territory have to request an authorization and/or declare themselves to the ANSM. Facilities located in France where RMPU is stored on behalf of distribution companies also fall within the scope of the authorization/declaration requirement. Facilities located in other European Member States must register with the authority competent in their own jurisdiction. Furthermore, the ANSM explains that certain subcontracting relationships do not qualify as distribution activities even though a sales and purchase transaction took place. For example, distribution activities of a pharmaceutical company "for own use," where RMPU is sold to a subcontractor exclusively for the purpose of manufacturing drugs which are then entirely purchased back by the pharmaceutical company, are not subject to authorization/declaration requirement. However, if part of the...

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