Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence

Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence  (otherwise known as an MIA Licence) for Batch Certification of Imported Medicinal Products for Veterinary Use.

Our MIA licence enables us to partner with companies to provide them with EU Qualified Person (QP) resources and importation and certification services of veterinary medicinal products in the EU.

We are now able to offer companies the opportunity to avail of our commercial MIA licence to certify veterinary medicinal products for release to the EU market.

What Are The Benefits?

Companies seeking to avail of our MIA can utilise it without having to substantially invest in the costly and thorough process of obtaining their own MIA licence.  This involves implementing a full quality management system (QMS). Partnering with Acorn Regulatory, companies can benefit in three ways:

  • Timeline reduction: Developing a QMS and starting the MIA application process can take up to 12 months. Collaborating with Acorn Regulatory will accelerate the lead-time.  It is also worth noting that Ireland is the only English-speaking country in the European Union.
  • Financial savings: It is financially more cost-effective to contract Acorn Regulatory to provide the required quality services instead of setting up an office and hiring a team of full-time employees in the EU.
  • Experience: Acorn Regulatory has a cross-functional team that supports clients every step of the way. Acorn Regulatory employees have extensive industry experience in Quality, Regulatory Affairs, Operations and Supply Chain and have a proven track record of delivering results for clients.

Options for QP Release for Clients:

  • Your company can get listed on the Acorn Regulatory MIA Licence so that our experienced staff can release your batches to the EU market on your behalf. This saves time, work and expense and will not require setting up your own legal entity in Europe.

or

  • You can also set up a  private limited company in Ireland. This requires, at a minimum, a General Manager and a QP. A Quality Management System (QMS) must be put in place for the QP to perform batch release. When the QMS is operational you will need to apply for the MIA with the Health Products Regulatory Authority (HPRA) of Ireland. This can take up to 12 months and a good working relationship with the HPRA is essential.

Working with Acorn Regulatory and utilising our MIA can save you time, effort and expense.

You might also need a Wholesale Distribution Authorisation (WDA)

If your distributor is based outside of Ireland, you will need to apply for a WDA locally in the new jurisdiction. Acorn Regulatory has extensive experience in WDA applications and WDA QMS management. Find out more about our WDA services by clicking here.

We Can Help

Talk to us today about your MIA needs.  Complete the form below, email us: info@acornregulatory.com, or call us on 00353 52 61 76 706.