If your company plans to manufacture medicinal products in Ireland, or import them from a third country into Ireland, you will typically need to establish the relevant manufacturing or import authorisation before those activities begin. In most cases, that means securing a Manufacturer’s/Importer’s Authorisation (MIA) from the Health Products Regulatory Authority (HPRA). The requirement itself is straightforward; the application process is less well understood, particularly by companies applying for the first time. This article sets out the MIA requirements, what the application process actually involves, and what realistically affects the MIA timeline.
What an MIA Authorises
A Manufacturer’s/Importer’s Authorisation is the authorisation issued by HPRA that permits a company to manufacture medicinal products in Ireland and/or import them from outside the European Economic Area (EEA). It is often referred to informally as an “MIA licence,” although HPRA and EU legislation use the term “authorisation” rather than “licence.”
Under HPRA’s Irish framework, authorisations are grouped into three categories, depending on the products involved:
- MIA – manufacturing and/or importation of medicinal products for human use
- V MIA – manufacturing and/or importation of veterinary medicinal products
- IMP MIA – manufacturing and/or importation of investigational medicinal products (IMPs) for use in clinical trials
Each authorisation is specific to the named site, the activities carried out there, and the products covered. Changes to the authorised site, activities or scope may require a variation to the existing authorisation, rather than a new application, depending on the nature of the change.
Why an MIA Is Required
The requirement for a manufacturing authorisation is set out in EU legislation, not simply industry convention. Directive 2001/83/EC requires Member States to ensure that the manufacture of medicinal products within their territory is subject to an authorisation. This requirement applies equally to products imported from third countries into a Member State.
This is a legal requirement, not a matter of best practice. A company that manufactures medicinal products in Ireland, or imports them from outside the EEA, without a valid MIA is operating outside the legal framework, regardless of how well its facilities or systems perform in practice.
It is worth being precise about what the MIA covers, because it is often confused with related but distinct regulatory activities:
- MIA authorisation permits the manufacturing and/or importation activity itself.
- QP certification is the formal act by which a Qualified Person confirms that a batch has been manufactured and tested in accordance with the relevant authorisation and Good Manufacturing Practice.
- Batch release is the subsequent status of making a certified batch available for the market or for clinical trial use. EU GMP Annex 16, “Certification by a Qualified Person and Batch Release,” treats certification and release together because release cannot happen without certification first taking place. Certification is a prerequisite step within the release framework, not a separate, unrelated act.
Holding an MIA does not mean a batch has been certified or released. It means the site and its holder are authorised to carry out the relevant manufacturing or importation activity. This authorisation is one of the preconditions for certification and release to happen at all. We’ve covered the certification and release stages separately in our guide to QP certification and batch release.
MIA Application Requirements
Under Directive 2001/83/EC, an applicant for a manufacturing authorisation must, at minimum:
- specify the medicinal products and pharmaceutical forms to be manufactured or imported, and the site where they will be manufactured and/or controlled;
- have suitable and sufficient premises, technical equipment and control facilities at that site, meeting the applicable legal requirements for manufacture, control and storage; and
- have the services of at least one Qualified Person available to the site.
These are the legal minimums. In practice, HPRA will expect to see a broader set of practical preparations already in place, or close to finalised, including:
- a pharmaceutical quality system appropriate to the scope of the authorisation;
- premises and equipment that have undergone appropriate qualification and validation;
- evidence of the nominated Qualified Person’s qualifications and experience;
- site documentation, such as a Site Master File describing the facility and its activities; and
- a clearly defined scope of the specific manufacturing and/or importation activities being applied for.
These preparatory expectations are not themselves listed in Article 41. They reflect what is generally needed in practice to satisfy the legal requirements above and to be ready for HPRA’s assessment.
For companies specifically applying for an authorisation to import from outside the EEA, EU GMP Annex 21, in force since 21 August 2022, sets out the GMP expectations that apply to MIA holders carrying out importation activities. This is a distinct annex from Annex 16, which concerns certification by a Qualified Person and batch release. The two are often referenced together because they sit close together in the supply chain. However, they address different regulatory activities, and an application should not conflate the two.
The HPRA MIA Application Process
HPRA structures new MIA applications around a pre-submission process rather than accepting applications cold.
1. Pre-submission meeting. Companies intending to apply for an MIA within the next six months are advised to request a pre-submission meeting with HPRA’s Compliance department, using HPRA’s dedicated request form. This meeting is held with HPRA’s inspection team and gives the company an opportunity to present its planned manufacturing or importation activities and raise questions about what needs to be in place.
2. Readiness confirmation. Based on that discussion, HPRA will issue the formal MIA application form once it has confirmed the company is likely to be ready for inspection within four to six weeks. This step exists specifically to avoid applications being submitted, and inspections scheduled, before a site is genuinely prepared.
3. Application submission. The company completes and submits the application, along with supporting documentation covering the site, its activities, and the nominated Qualified Person.
4. GMP inspection. HPRA’s inspection team assesses the site against the relevant Good Manufacturing Practice requirements for the activities applied for. For an importation-focused application, this will include assessment against the requirements in Annex 21.
5. Outcome and any follow-up. Depending on the inspection findings, HPRA may request further information, corrective action, or evidence of remediation before an authorisation is granted. HPRA does not routinely issue hard-copy authorisations. Granted MIAs are recorded on the EudraGMDP database, where their validity can also be verified.
For companies that want to discuss facility design at an earlier stage, particularly where a new site is being built or substantially upgraded, HPRA also facilitates earlier regulatory review meetings with its GMP inspectors, separate from the formal pre-submission process.
What Affects the Timeline
HPRA does not publish a fixed, guaranteed turnaround time for new MIA applications, and any figure quoted without qualification should be treated with caution. What HPRA does confirm is the shape of the process rather than a single overall duration:
- the pre-submission stage is intended to establish, in advance, whether a site is likely to be ready for inspection within four to six weeks;
- beyond that point, the time to a decision depends on inspection scheduling, the outcome of the inspection, and whether any follow-up or remediation is required.
In practice, the main variables that influence how long an application takes, and the points where delays most often arise, are:
- Readiness at the point of pre-submission. Requesting a pre-submission meeting before qualification, validation or documentation is genuinely complete tends to surface gaps that need resolving before an application form can be issued.
- The nominated Qualified Person. A QP whose qualifications, experience and availability are not clearly documented can hold up an otherwise ready application.
- Accuracy of the Site Master File and application scope. A Site Master File that doesn’t accurately reflect the activities applied for can generate additional queries during assessment. So can an application scoped more broadly than the site can currently demonstrate.
- Inspection findings. Significant deficiencies identified at inspection require a remediation and follow-up cycle before authorisation can be granted.
- How far in advance the company engages HPRA. HPRA advises companies intending to apply within the next six months to request a pre-submission meeting. Engaging later than that leaves less room to address any issues before formal submission.
Because these factors vary from one application to the next, there’s no fixed industry-wide duration to assume in advance. The pre-submission stage is generally where a company gets its clearest indication of timing. Addressing the points above before requesting that meeting, rather than during it, is generally the most effective way to keep the process on track.
How MIA Authorisation Fits the Wider Picture
An MIA is a starting point, not an end point. Once a site holds a valid authorisation covering the relevant manufacturing or importation activity, batches can then proceed through Qualified Person certification and, ultimately, batch release. For imported products specifically, EU GMP Annex 21 states that QP certification or confirmation of a batch takes place only after physical importation and customs clearance into the customs territory of an EU/EEA state. The site carrying out that importation must hold the appropriate MIA.
For a company weighing up how to structure EU market access, the practical reality to plan around is this sequence: MIA authorisation, then certification, then release — whether the MIA involved is the company’s own or one it accesses through an authorised partner.
How We Can Help
Not every company needs, or wants, to establish and hold its own MIA. Inglasia holds its own Manufacturer Importation Authorisation. Our EU pharmaceutical importation and MIA services manage imports under that authorisation on behalf of clients, for products and importation activities within its scope. This can allow a company to access a compliant EU import route without establishing and maintaining its own MIA.
This route doesn’t remove the regulatory picture described above. It simply changes who holds the authorisation. HPRA’s requirements for importation still apply, and QP certification and batch release still follow the same sequence. Responsibilities such as those of the Marketing Authorisation Holder remain with the client company. Whether this route or your own MIA is the better fit depends on your products, volumes and longer-term plans for the EU market.
We are not the regulator and cannot influence HPRA’s assessment of any authorisation, whether it’s ours or a company’s own application. If you’d like to talk through which route suits your situation, contact our team.