The Manufacturing and Import Authorisation, often referred to as the MIA, is the regulatory authorisation for a facility to manufacture certain medicinal products or import them from a third country. For investigational medicinal products, it concerns the permitted activities and the specific site, not the authorisation of an individual product. Its scope can cover processing, packaging, quality control, batch certification, storage, or importation.
Authorisation for the Facility and Site
The MIA is linked to the activity of a manufacturer or importer. The Union format includes details of the authorisation holder, the addresses of the manufacturing sites, the scope of the authorised activities, and the legal basis for the grant. If several sites are not covered by separate authorisations, they should be listed within the authorisation; separate annexes may be required for the respective manufacturing or import operations carried out.
For investigational medicinal products, the format provides a dedicated annex for manufacturing and import activities. The authorisation is therefore not a general quality statement about a company, but specifies which operations are covered at which location under the authorisation. Secondary packaging, for example, can include labelling and the assembly of the components described in the product specification file; such an activity must fall within the authorised scope.
A manufacturing authorisation is also required for importation from third countries. This means more than the physical arrival of a shipment: import functions require entities authorised under the MIA, documentation of transport and receipt, and a clear allocation of roles for import, QP activity, and further processing.
Relation to the Qualified Person and to Importation
Each EU manufacturing site should have at least one Qualified Person. The MIA is the organisational and legal framework within which a QP carries out the batch-related duties assigned to them; it is not a substitute for those duties. Annex 16 explicitly requires that certification be permissible under the conditions of the manufacturing authorisation. The names of Qualified Persons may also appear on the MIA as optional information.
For imported products, at least the site of physical importation and the site of QP certification or confirmation are relevant. Annex 21 requires an appropriate MIA for both functions. QP certification or confirmation takes place only after physical importation and customs clearance in an EU/EEA country. The site holding QP responsibility must have access to the records relating to the underlying manufacturing and import steps.
For investigational medicinal products originating from third countries, manufacturing and the associated quality documentation must also align with the clinical trial authorisation and the relevant quality agreements. The MIA addresses whether the EU site is permitted to carry out the task; it does not independently certify the conformity of each individual imported batch.
Distinction from Marketing Authorisation and GMP Certificate
The Manufacturing and Import Authorisation is not the marketing authorisation for the medicinal product. The marketing authorisation concerns the product and its commercialisation; the MIA concerns the facility, its sites, and the operations authorised there. For investigational medicinal products, the clinical trial authorisation is also decisive, since these products must not be equated with a general marketing authorisation.
Likewise, the MIA is not equivalent to a GMP certificate. A GMP certificate documents the status of GMP compliance following an inspection and may relate to specific units or buildings. The MIA, by contrast, authorises which manufacturing or import activities an operator may carry out. In official EU documentation, the two appear as separate regulatory instruments.
The existing glossary entry for marketing authorisation therefore operates on a different level. In the case of a site change, a valid product marketing authorisation may remain in effect while the new manufacturing site has yet to obtain the required MIA. Conversely, an MIA does not confer any right to place a medicinal product on the market in general.
Relevance for clinical trials
For clinical trial supply chains, it must be established early on whether every planned activity takes place at an appropriately authorised site. This concerns not only the actual production, but also third-country importation, packaging, labelling, testing, and, where applicable, certification. If a service provider or depot expands its role, the scope requiring authorisation may change, even though the product formulation and study protocol remain unchanged.
Full-service CROs such as Mediconomics provide support by mapping the manufacturing, import, and packaging sites involved, by aligning site roles with the clinical trial supply chain, and by documenting the evidence required for the investigational medicinal product dossier. This ensures that facility authorisations, QP steps, and trial-related approvals are not mistakenly treated as the same release step.
Frequently Asked Questions (FAQ)
Does an MIA automatically cover all of a manufacturer’s activities?
No. The scope is defined by site and authorised operations. Activities such as processing, packaging, testing, certification, or importation must be covered within the respective authorisation framework.
Does importing an investigational medicinal product from a third country require an MIA?
Yes, the import function must be carried out by an appropriately authorised entity. Annex 21 distinguishes in particular between the site of physical importation and the site of QP certification or confirmation.
Does an MIA replace the clinical trial authorisation?
No. The MIA authorises the facility to carry out specified manufacturing or import activities. The clinical trial authorisation determines the regulatory conditions under which the investigational medicinal product may be used in the trial.
Regulatory References
- Regulation (EU) No 536/2014, Article 61 – subjects the manufacturing and importation of investigational medicinal products to an authorisation requirement.
- EU GMP Guide, Annex 16, Section 1.4 – sets out the role of QPs at EU manufacturing sites and shared responsibility.
- EU GMP Guide, Annex 21 – describes GMP requirements for MIA holders regarding the importation of medicinal products and investigational medicinal products.
- Directive 2001/83/EC, Article 40 – is the legal basis for the manufacturing and import authorisation for human medicinal products.