Insights

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

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 RMPU is not sold back to the pharmaceutical company, this company is considered to be a distributor subject to authorization/declaration.

Additionally, updated FAQs relating to the inspection of RMPU facilities by the ANSM were issued by the ANSM on March 9, 2017. It specifies that the obligation for drug manufacturers to conduct their activities according to the Manufacturing Good Practices defined by the ANSM applies not only to materials destined for human use, but also to materials destined for veterinary use. However, the Distribution Good Practices for active substances only applies to human-use materials. Additionally, while all computerized distribution management systems must be validated for human-use materials, this validation obligation only applies to "computerized systems that impact critical activities" for veterinary-use materials.

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