MIA: manufacturing and importation authorisation

Article 40 of Directive 2001/83/EC makes manufacture subject to an authorisation granted by the Member State where the activity takes place, and the same requirement covers import from third countries. Manufacture includes partial operations such as packaging, labelling and batch release, so a company that only packs or only releases imported product still needs an MIA. Articles 41 to 45 set the conditions: the applicant must specify the products and pharmaceutical forms, the operations and the site; must have suitable premises, equipment and control facilities; and must have at least one qualified person at its disposal. Article 46 lists the holder's obligations, including compliance with GMP and the use of only authorised active substance suppliers, and Article 46b governs imported active substances.

An MIA is granted per site and per scope. The annex to the authorisation lists the dosage forms, the operations (manufacture, primary and secondary packaging, quality control testing, batch certification, importation) and any restrictions, and the EU has a common format for the document, which is published in EudraGMDP. Changes to the products, operations or site, or to the qualified person, must be applied for before they are implemented. Wholesale distribution is a separate authorisation under Article 77, and active substance manufacture and import is a registration under Article 52a rather than an MIA.

The MIA is what a marketing authorisation application points to when it names a finished product manufacturer or an importer and batch release site in the EEA. Assessors check EudraGMDP for the site's authorisation and its scope, and a mismatch between the operation proposed in the dossier and the operations listed in the MIA is a validation question.

What goes wrong: a site certifies a new dosage form that is outside its MIA scope; the qualified person named on the authorisation left and the replacement was never notified; a company imports product for EU release from a third country without the importation operation on its licence; and a group assumes an affiliate's MIA covers a sister company at the same address when the authorisation is tied to the legal entity named on it. Each of these surfaces at validation or at inspection, and both delay the procedure that depends on the site.