Changing the holder of a human medicinal product: tasks up to completion

The first step is to classify every authorisation concerned. For a purely national procedure and for mutual recognition or decentralised procedures, BASG is the relevant authority for the Austrian submission. The BASG guide on electronic submissions expressly lists the transfer of an authorisation or registration as its own procedure under section 25 AMG. For centralised authorisations, the same guide refers to EMA.

This classification determines the submission format, the countries involved, the product information and the communication channels. The acquirer should therefore prepare a product-by-product table with the authorisation number, route, Member States, current holder, local representative, marketing status and open procedures. The contract can refer to this table instead of relying on a blanket handover clause.

A change of name or address of the same legal person is different from a transfer to another legal person. EMA treats a change of name or address as a separate matter. This distinction prevents a corporate name change from being mistaken for a transfer of the marketing authorisation.

The acquirer needs access to the complete and current authorisation file. This includes the approved modules or dossier parts, decisions, responses, variations, obligations and approved product information. EMA requires a declaration for a central transfer that the complete current product file, or a copy, has been made available to the transferee.

Pharmacovigilance needs special attention. Under section 75i(1) AMG, as explained by BASG, every marketing authorisation holder must monitor pharmacovigilance data for new or changed risks and changes to the benefit-risk balance. The new holder must therefore be able to demonstrate its pharmacovigilance system, qualified person and the location of the pharmacovigilance system master file. Open PSURs, risk management measures, safety communications, DHPCs and follow-up activities belong in the handover list.

The acquisition agreement cannot permanently shift regulatory responsibility back to the former holder. The parties can allocate transitional services contractually. Responsibility after the relevant transfer point must match the authority status and the new holder's organisational capacity.

The change affects visible and operational product data. For transfers, the BASG guide names the national summary of product characteristics, package leaflet, labelling and, where relevant, mock-ups. These documents must fit the submission and the implementation plan. For a central transfer, EMA requires revised product information in the relevant EU languages and an update of URLs or QR codes that still refer to the former holder.

Batch planning needs its own date. For centrally authorised products, EMA describes a transitional period in which stock bearing the former holder's name may continue to be placed on the market under the agreed arrangements. From the effective transfer, the new holder assumes responsibility for released batches. After the implementation day, only batches under the new holder's name may be released and placed on the market. The specific product and authority decision must be checked.

The acquirer must also review supply continuity and any supply restrictions in Austria. BASG explains that a change of the marketing authorisation holder or reporting party may require written notification for ongoing supply restriction reports. The handover plan should therefore record pack sizes, marketing status, stock and reports at the relevant date.

For each authorisation, the purchase agreement should state which authority decision must exist before completion and which steps may follow until the implementation date. This includes preparing and submitting the transfer, powers of attorney, dossier access, responsibility for questions, costs, transitional assistance and updates to national product information.

Ongoing variations and other post-authorisation procedures need a clear rule. EMA advises against uncoordinated parallel submission of a transfer and variation procedures. If a regulatory deadline falls during the pending transfer, the parties must clarify who submits and how the new holder continues the procedure after the decision. Put this coordination into the disclosure and handover list.

A condition to completion should describe the authority requirement precisely. Merely starting a procedure is insufficient where the buyer requires a decision or a defined status before taking over economically. Set a long-stop date for the longest realistic procedure and govern extension, termination and transitional services.

The answers provide an initial orientation. The relevant route, decision, product and procedural status remain decisive.