Databasing non-company ADRs
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Is it necessary for a generics company with only products licensed in the EU, to database ICSRs where it is clear that the drug is not the company’s e.g. by batch number, country of occurrence, formulation, route etc. The source could be literature or ASPRs etc. If yes, where is this stated in GVPs or other guidance?
If the Generics Company is not the Marketing Authorisation Holder they would not be required to database ICSRs. However, even though the generics company is not the MAH if there is a commercial agreement between both companies and an agreement to transfer safety data to the MAH then any adverse effects or ICSRs that happen post marketing should be reported by the generics company to the MAH so that they can store in their database for Pharmacovigilance. If the Generics company is the Marketing Authorisation Holder the ICSRs should be reported in accordance with GVP reporting requirement in EU, Guideline on good pharmacovigilance practices: Module VI ‘Management and reporting of adverse reactions to medicinal products’.