In detail
Term and legal framework
Interim Marketing Authorisation Holder is not a term defined in pharmaceutical law but a label used in practice. Legally, the iMAH is simply the marketing authorisation holder, with all the associated obligations. Under Section 4(18) of the German Medicinal Products Act (AMG), the holder of the marketing authorisation is the pharmaceutical entrepreneur for products requiring authorisation. Section 9(2) AMG only permits a pharmaceutical entrepreneur 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 its legal responsibility.
When the model is used
- A company outside the EEA wishes to offer a medicinal product in the EU but does not yet have its own 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 bridged during a sale or restructuring.
Obligations of the authorisation holder
Anyone placing finished medicinal products on the market in Germany as a pharmaceutical entrepreneur must, among other things, appoint an EU-based graduated plan officer for pharmacovigilance under Section 63a AMG and an information officer under Section 74a AMG. Life cycle management of the authorisation and responsibility for labelling and product information also apply. The role of authorisation holder does not require 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 a transfer 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 responsible person. For nationally authorised products, the procedures of the relevant authority apply. Anyone planning this model should prepare the transfer contractually from the outset.
In practice at A&O Pharma
As part of our regulatory affairs services, A&O Pharma acts as Interim Marketing Authorisation Holder on request and takes care of submission and life cycle management of the authorisation. We provide functions such as graduated plan officer under Section 63a AMG and information officer under Section 74a AMG through interim management. With our own manufacturing authorisation under Section 13 AMG, we also carry out EU batch release.
Regulatory AffairsFrequently asked questions
Does a marketing authorisation holder need a manufacturing authorisation?
No, the role of authorisation holder does not require a manufacturing authorisation of its own. Batch certification is performed by the Qualified Person of an authorised manufacturer or importer.
Can a company from the US or Switzerland itself be the marketing authorisation holder in Germany?
No. Under Section 9(2) AMG, the pharmaceutical entrepreneur must have its seat in the EU or the EEA. This is exactly where the iMAH model comes in.
How is the authorisation later transferred to the final holder?
For centrally authorised products, through 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.
