In detail
Term and legal framework
The term interim marketing authorisation holder is not defined in pharmaceutical law; it is a label used in practice. Legally, the iMAH is the marketing authorisation holder in the full sense, with all the associated obligations. Under § 4(18) of the German Medicinal Products Act (AMG), for products that require a marketing authorisation, the marketing authorisation holder is the pharmaceutical company legally responsible for them. § 9(2) AMG only permits a pharmaceutical company with its seat in the EU or the EEA to place medicinal products on the market in Germany. Appointing a local representative does not release it from this responsibility.
When the model is used
- A company outside the EEA wants to market a medicinal product in the EU but does not yet have its own legal entity there.
- A commercial partner has not yet been chosen or is not yet ready to take over the marketing authorisation.
- A marketing authorisation needs to be held on an interim basis during a sale or restructuring.
Obligations of the marketing authorisation holder
Any pharmaceutical company placing finished medicinal products on the market in Germany must, among other things, appoint an EU-based Stufenplanbeauftragter (German QPPV) under § 63a AMG and an information officer under § 74a AMG. Lifecycle management of the marketing authorisation and responsibility for labelling and product information are also part of the role. The marketing authorisation holder does not need a manufacturing authorisation of its own. Batch certification is carried out by the Qualified Person of a manufacturer or importer holding the relevant authorisation.
Transfer of the marketing authorisation
The model ends with the transfer of the marketing authorisation to the final holder. For centrally authorised products, the procedure is governed by Commission Regulation (EC) No 2141/96. Among other things, EMA requires proof that the new holder is established in the EEA and details of its pharmacovigilance system, including the QPPV. For nationally authorised products, the procedures of the competent national authority apply. Anyone planning to use this model should provide for the transfer in the contract from the outset.
In practice at A&O Pharma
As part of its regulatory affairs services, A&O Pharma can act as interim marketing authorisation holder (iMAH) and handle the submission and lifecycle management of the marketing authorisation. Through interim management we provide functions such as Stufenplanbeauftragter under § 63a AMG and information officer under § 74a AMG. Under our own manufacturing authorisation (§ 13 AMG), we also carry out EU batch release.
Regulatory AffairsFrequently asked questions
Does a marketing authorisation holder need a manufacturing authorisation?
No, the marketing authorisation holder does not need a manufacturing authorisation of its own. Batch certification is performed by the Qualified Person of an authorised manufacturer or importer.
Can a company based in the US or Switzerland hold the marketing authorisation in Germany directly?
No. Under § 9(2) AMG, the pharmaceutical company must have its seat in the EU or the EEA. This is exactly the gap the iMAH model fills.
How is the marketing authorisation later transferred to the final holder?
For centrally authorised products, via EMA under Regulation (EC) No 2141/96; for national authorisations, under the procedures of the competent authority. The new holder must be established in the EEA.
