Please find below a short questionnaire and explanatory letter from Ordre des Pharmaciens, in France regarding company responsibilities and their position of Chief Pharmaceutical Officer (Pharmacien Responsable). Please would you complete the questionnaire and send to me by the end of this month so that your responses can be discussed at the EIPG General Assembly.
The EU law establishes that the MAH must be established in the Union, the QPPV must be resident in the Union, the MAH must designate local representatives, the batch certification /release must be performed in the EU, etc
In addition, in case the establishment is located inFrance it exists a specific situation regarding the marketing of medicinal products:
He/she must member of the Board of Directors
The advantages of such status is to be informed of all the aspects concerning a medicinal products: manufacturing (ie batch certification and tracking…) and any issues (ie : batch complaints, recall decision….), pharmacovigilance issue, communication to HCP (promotional and non promotional or medical information …), storage and distribution condition, and can assure the authorities of the best use of the medicinal product.
This “exploitant” status does not exist in most of the European countries, and the Qualified Person does not have all the responsibilities of the Chief Pharmaceutical Officer.
We wish to have a better understanding how it goes in different European countries and what advantage you would see to the French organization, or what kind of obstacle you foresee to have it applied in your country.
https://www.rpharms.com/Portals/0/Groups/37/FRANCE GPIE responsible pharmacienB SURVEY.docx?ver=2018-04-23-160502-537