Thinking of launching a Commercial Product or expanding a Clinical Trial? See how MIAS Pharma can help.

Do you Wish to Market Medicinal Product in Europe?

To comply with European licensing requirements to import medicinal product you must have a presence in the EU/EMEA and you will also need one or more of the following:

  1. A Manufacturer's/ Importation Authorisation (MIA). This is a licence granted by European Competent Authorities.
  2. A Wholesale Distribution Authorisation (WDA). This is a licence granted by European Competent Authorities.
MIAS Pharma Limited is Ireland's only consultancy authorised to release investigational and commercial medicinal products into Europe under its own licences and support product importation.


About MIAS Pharma

MIAS Pharma Limited, your European Partner, provides contract services to enable you to import and batch release medicinal products in to Europe in a compliant manner with no significant investment in licence application, maintenance activities or office/personnel costs.  

MIAS Pharma Limited holds two MIAs to cover medicinal products for human use in EU/EEA:

1. MIA for Investigational Medicinal Products (IMPs)

2. MIA for Commercial Products

MIAS Pharma provides oversight of:

  • European Qualified Person (QP) services
  • Regulatory compliance of manufacturing activities
  • Regulatory compliance of Analytical Testing and Retesting through strategic partnership
  • Regulatory compliance of Repackaging / Relabelling services through strategic partnership
  • Regulatory compliance of Shipment and Transportation activities through strategic partnership
  • Compliance with responsibilities as a Market Authorisation Holder (MAH)
If you are interested in exploring how we can help you, please get in touch to discuss how MIAS Pharma Limited can assist your organisation, contact us at +353 01 846 3605/4 or info@miaspharma.com.

Benefits of using MIAS Pharma:

  1. Time to market: 2-4 month lead time v typical 9-12 month lead time to develop a PQS and obtain authorisation.
  2. Cost savings: Outsourcing EU quality function (including QP activity) v employing EU Quality team.
  3. Insights and Expertise: Our CEO is a former senior inspector with the Irish Competent Authority (HPRA) and is considered a Thought Leader in the area of EU GMP and GDP compliance.
  4. Measured growth: Ability to size up your European operations following proof of concept.

These contract services will enable you to import and batch release medicinal products in a compliant manner with no significant investment in licence application or maintenance activities or office/personnel costs.

MIAS Pharma your Partner in Europe.

Contact our team today to initiate your European Experience.

Email: info@miaspharma.com

Telephone: 00 353 (01) 8463605


MIAS Pharma International performs selection / qualification audits of all our strategic partners to confirm the standards meet GMP / GDP requirements. These audits are open to inspection by the HPRA and our clients.

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