Using a Third-Party MIA Licence Holder When You Have No EU Site

Your product is made outside the EU, and you want to supply it to EU patients. You have no EU legal entity, no warehouse and no Qualified Person (QP). To import medicines into the EU, a site needs a manufacturing and importation authorisation (MIA), often called an MIA licence. A non-EU company does not have to apply for its own. It can import under the MIA licence of a company that already holds one. This post explains how that arrangement works, what stays with you, and what to ask before you choose an MIA holder.

Key takeaways

• A non-EU company does not need its own MIA to import into the EU. The site that physically imports, and the site where the QP certifies, must each hold an MIA, and the QP certifies only after importation and customs clearance.
• The MIA holder is responsible for its own site and QP, but the marketing authorisation holder (MAH) keeps overall responsibility for placing the product on the market.
• A third-party MIA holder solves the import question, not the MAH question. Agree the quality agreements with the holder and the third-country manufacturer before the first shipment.

Using a third-party MIA licence holder: the short answer

A third-party MIA holder is an EU or EEA company whose authorisation covers the importation of medicinal products from outside the EU and EEA. It physically receives your batches at its authorised site and keeps them in quarantine. A QP then certifies each batch, either at that site or at another site that holds an MIA. EU GMP Annex 21, section 2.1, names these two sites, the site of physical importation and the site of QP certification, and says both must be authorised under an MIA. Section 4.2 requires imported products to be stored under quarantine until QP certification.

You do not need your own MIA for this. The responsibilities of the marketing authorisation holder (MAH) stay with the MAH, which must be established in the EU. That may be your EU entity or an EU-established party you have appointed. The arrangement changes who holds the authorisation. It does not remove the need for QP certification after physical importation and customs clearance (Annex 21, section 2.1).

If you are weighing this route against your own licence, read applying for your own MIA in Ireland alongside this post.

Why an MIA is tied to the site that imports, not to who owns the product

The EU legislation cited in this post is linked from legislation.gov.uk, which holds the text of Directive 2001/83/EC and Regulation (EU) No 536/2014 as at 31 December 2020 and Regulation (EC) No 726/2004 as adopted in 2004.

Under Article 40(3) of Directive 2001/83/EC, the authorisation that Article 40(1) requires for manufacture is also required for imports coming from third countries.

Annex 21 of the EU GMP Guide sets out the GMP requirements for MIA holders who import. The Commission document is dated 16 February 2022 and its stated date for coming into operation is 21 August 2022. It defines importation as physically bringing a medicinal product from outside the EEA/EU, and says fiscal transactions are not part of the annex.

Two points follow from that definition:

• The authorisation follows the site. The site where the product physically arrives needs an MIA. If QP certification happens at a different site, that site needs an MIA as well (Annex 21, section 2.1).
• Importation is a physical act. Annex 21 defines importation as physically bringing the product in and leaves fiscal transactions outside its scope. The importation responsibilities sit with the sites that physically import and certify.

On that definition, owning the product or selling it in the EU does not, on its own, give you the importation role that Annex 21 describes. Someone has to operate an authorised site. That site can be yours, or it can belong to a third party.

QP certification takes place only after physical importation and customs clearance into the customs territory of an EU or EEA state (Annex 21, section 2.1). Plan the shipment so it reaches the MIA holder’s site with its documents ready.

What does it mean to hold an MIA on behalf of another company?

The phrase is common, but it can mislead. The MIA holder does not hold an authorisation in your name. It holds its own authorisation, for its own site, people and quality system, and it uses that authorisation to import products for clients.

In practice, an MIA holder offering this service typically does the following. The order and detail differ between providers and are set in the agreements:

1. receives the batch at its authorised site and keeps it in quarantine;
2. checks the import documents and the shipment against what was agreed;
3. arranges any testing required on import;
4. passes the batch to a QP for certification, at its own site or under a written agreement with another authorised site;
5. releases the certified batch from quarantine to the agreed next step in the supply chain.

For a product with a marketing authorisation, the certifying QP must ensure it was tested upon importation in the Union, unless appropriate arrangements exist between the Union and the third country, such as a mutual recognition agreement (MRA) (Annex 21, section 2.4). Article 51(1)(b) of Directive 2001/83/EC sets out the import testing: a full qualitative analysis, and a quantitative analysis of at least all the active substances, in a Member State. Article 51(2) relieves the QP of that where such arrangements with the exporting country exist and the controls were carried out there. The EMA’s MRA page says the agreements aim to waive batch testing on import, and that their scope differs by partner country and product type. Ask early whether your product falls under an MRA, because the answer changes the work and the timeline.

The arrangement is used by companies such as non-EU companies whose product is authorised through an EU-established MAH, virtual pharma companies, biotech sponsors moving to commercial supply, and contract manufacturers supplying EU customers.

Who stays responsible: the MIA holder, the QP and the marketing authorisation holder

Responsibility is split between the parties. It does not move from you to the MIA holder as a whole.

• The MIA holder is responsible for its own site. Annex 21 expects the sites doing importation to have a pharmaceutical quality system (section 3.1) and adequate premises and equipment (section 4.1), and the holder must have a QP at its disposal (Directive 2001/83/EC, Articles 41 and 48).
• The QP is responsible for securing that each batch meets the requirements of Article 51 of Directive 2001/83/EC, and certifies this in a register or equivalent document. For an imported batch, Annex 21 (section 2.4) requires the certifying QP to ensure that it was manufactured to EU GMP or recognised equivalent standards.
• The marketing authorisation holder keeps overall responsibility for placing the product on the market. Annex 21, section 2.3, says that for products authorised in the EU or EEA, overall responsibility for placing the medicinal products on the market lies with the MAH. Section 7.1 adds that provisions for handling complaints, quality defects and recalls between the importing sites, the third-country manufacturer and the MAH or sponsor should be defined in contractual arrangements. Settle those provisions in writing before the first shipment.

A non-EU company also needs to check its own position as MAH. Article 8(2) of Directive 2001/83/EC says a marketing authorisation may only be granted to an applicant established in the Community. For centrally authorised products, Article 2 of Regulation (EC) No 726/2004 says the holder must be established in the Community. Using a third-party MIA holder solves the import question. It does not solve the MAH question, which has to be settled separately from the import route.

The agreements that connect you, the MIA holder and your manufacturing sites

Annex 21, section 2.6, says written agreements should be in place between the sites performing manufacturing and importation activities and the MAH or sponsor, in line with Chapter 7 of the EU GMP Guide. For a typical non-EU company, expect to need arrangements such as:

• a quality agreement between you and the MIA holder, setting out who does what for each step from shipment to release;
• an agreement covering the third-country manufacturer, so the MIA holder and its QP can get the batch documents, audit reports and change notifications they need;
• an agreement with any EU testing laboratory used for import testing;
• where certification happens at a different site from the physical import, an agreement between those two sites, including how quarantined stock is controlled before the QP’s decision.

The QP needs to be able to rely on the third-country site. Annex 21, section 5.4, expects documentary evidence that the site performing QP certification has qualified the third-country manufacturer and monitors it through periodic on-site audits, by itself or through a third party. Expect the MIA holder to ask for the information it needs for that.

Gaps in these agreements can delay release. Agree them before the first shipment, not after it arrives.

How to evaluate a third-party MIA holder

These are the questions to ask before you choose a holder. Ask for the answers in writing. Inglasia is itself an MIA holder, so put the same questions to us.

1. Scope of the authorisation. Does its MIA cover importation from outside the EEA, for your type of product: human, veterinary or investigational? The HPRA says separate MIAs are required depending on the scope of products, and you can verify electronic authorisations on EudraGMDP.
2. Product fit. Does its site handle your dosage form, storage temperature and any special controls, for example cold chain or controlled drugs?
3. QP arrangement. Who certifies your batches? Is the QP employed by the holder or engaged under a contract?
4. Testing. Where will import testing take place, and how are test methods transferred to that laboratory?
5. Quarantine and release. How is quarantine status controlled, and what happens to a batch once certified?
6. Inspection history. When was the site last inspected by its competent authority, and is a GMP certificate available? EudraGMDP lists GMP certificates and statements of non-compliance, so you can check part of this yourself.
7. Documents it expects from you. Ask for its list of the batch documents, quality agreement terms and audit evidence it needs before the first import.
8. Exit. If you later move to another holder or to your own MIA, how are records, stock and open batches handed over?

Compare the answers with the EU GMP expectations for importers, because those are the standards that apply to importers.

When your own MIA is the better fit

A third-party holder suits a company that needs a compliant import route without building an EU site. Your own MIA can make more sense when:

• you plan to establish an EU legal entity and site anyway;
• your volumes or product range justify your own premises, quality system and QP;
• you want direct control of release scheduling.

Your own MIA means suitable premises, equipment and control facilities and at least one QP (Directive 2001/83/EC, Article 41). The HPRA’s guidance describes a pre-submission meeting before you apply. Our post on applying for your own MIA in Ireland covers that route, and the guide on how to import medicinal products into the EU shows where the MIA sits in the wider import process.

What changes for IMPs and when moving to commercial supply

Investigational medicinal products for EU clinical trials need an authorisation of their own. In Ireland the HPRA requires separate MIAs depending on the scope of products, with human medicines, veterinary medicines and IMPs listed separately. For trials, Article 61 of Regulation (EU) No 536/2014 requires an authorisation to manufacture and import IMPs, and the applicant must have at least one QP.

If you are moving from clinical supply to a commercial product, check that your MIA holder’s authorisation covers both scopes. Because the HPRA issues separate MIAs by scope, an authorisation for IMPs does not by itself show that a holder may import your commercial product. The reference document also changes: Annex 21 (section 5.1.1) has the QP certify or confirm a batch in line with the marketing authorisation or the clinical trial authorisation, as applicable. Start that conversation before approval, so the commercial import route is ready when you need it.

How We Can Help

Inglasia Ireland imports medicinal products into the EU under its own MIA, for companies that do not hold one. We verify the manufacturer’s records and carry out a compliance check. The responsibilities of the marketing authorisation holder stay with the MAH. QP certification is a separate step, which we provide through our QP batch release service. We are not the regulator and cannot influence the decisions of the HPRA or any other authority.

For support with importing through an MIA holder, see our EU pharmaceutical importation and MIA services and QP batch release services pages. To talk through which route suits your product, contact our team.