Marketing Authorization Holder Agreement

A modification of the elements of the pharmacovigilance file (PSMF), z.B of the person qualified pharmacovigilance (QPPV) or the PSMF site resulting from the transfer of the marketing authorization (MA) may be notified as part of the deferral application without separate change (see also “How to submit my application for marketing authorization delegation”). For the drug, enforceable measures may be agreed after marketing authorization at the time of issuance of the marketing authorization or subsequent changes. If these MMMs for the drug in question are still in place, it is the purchaser`s responsibility to implement them within the previously agreed time frame. However, the Agency may, by mutual agreement with the ceding and the ceding, set a transposition date for the transfer. This transposition date must be understood as the date on which the purchaser assumes all responsibilities. This date is indicated in the Agency`s opinion as well as in the European Commission`s decision. (See also “5. How do I choose the implementation date? »). When you delegate activities, communication is the key. HDMs can facilitate compliance by implementing robust and documented two-way communication systems, with production sites, qualified people and all relevant organizations for post-market quality control. Activities necessary to ensure GMP compliance may be delegated by the MAH to a manufacturer or other third party, but the MAH retains ultimate responsibility.

In deleging activities, it is essential that the roles and responsibilities of each party be clearly defined and, in the GMP guide, there are obligations to ensure that all outsourced activities are described in writing. This provision is generally provided by a technical agreement specifying the respective responsibilities of the MAH, the manufacturer and other third parties. This page lists the questions that market authorization holders (MAHs) may have in the event of a transfer of marketing authorizations. It provides an overview of the European Medicines Agency`s position on issues that are generally discussed in discussions or meetings with HDAs in the post-market authorisation phase. The revised themes are marked “New” or “Rev.” when published. MAHs should avoid submitting variation procedures in conjunction with a request for authorization to transfer marketing authorizations. The name and/or address of the MAH are not MA transmissions if the holder remains the same person/legal entity. This change should be notified through an IAIN, A.1 modification application. The delegation notice is forwarded to the taker, the taker, the European Commission and the relevant authorities in Iceland and Norway. The European Commission will then make a decision on the transfer of the AD. The delegation of the marketing authorisation is authorized from the date of notification of the Commission`s decision on the delegation.