EU Site of Importation, Customs and Distribution.

EU Pharmaceutical Importation Support

MIAS Pharmas has an MIA approved by the HPRA (The HPRA stands for Health Products Regulatory Authority, which is the regulatory body responsible for the regulation of medicines, medical devices, and other health products in Ireland) which can be used to support our clients to import and QP release from a third country (USA/ Canada/ Asia / Middle East) etc. Pharmaceutical products do not have to touch Ireland and can go directly to the EU market of choice providing that the selected warehouse in your supply chain holds the relevant licences (WDA / MIA). 

Although Batch release is and will continue to be our core service offering on request via our external partners MIAS can offer and end to end solution to bring your product from your country of choice and support you to cash transaction to your target customers.  

Providing end-to-end solution to facilitate your pharmaceutical product

SUPPORT & QUALITY

QP Familiarisation may include:

  • Manufacturing process and controls
  • DS and excipient control
  • Qualification/validation (process and cleaning)
  • Packaging process
  • Preventative maintenance and calibration controls
  • MA review
  • QC methods and product specifications
  • Method validation/verification
  • Stability review
  • Quality Systems in place

  • Previous PQRs

  • Supply chain qualification

Should a client go the route of naming their own QPs on a MIAS MIA, these QPs will require training on the MIAS Pharma PQS. MIAS will also apply a quality oversight of the arrangement to safeguard the quality standards governing batch disposition.

The legislation behind this is as follows:

“EU Directive 2001/20/EC states that the QP is responsible for ensuring that each batch of medicinal products has been manufactured and checked in compliance with the requirements of EU law, the principles and guidelines of GMP for medicinal products for human use and that in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC (and) in accordance with the product specification file.”

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