The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside of the Union.

As required by the HPRA “A manufacturer’s authorisation (MIA) is needed if a company is involved in any of the following manufacturing activities:  processing of a dosage form, primary packaging, secondary packaging, batch certification, physical importation of medicinal products or batch certification of medicinal products coming from a third country”  Therefore, Importation of a pharmaceutical finished product manufactured in a third country requires a MIA, for the site where QP certification occurs and the site that physically imports the product, as well as EU testing sites if the batch is not made in an MRA country.

Physical importation and QP certification are different activities and can take place at the same or different authorised sites within the EEA. If the Physical importation and QP certification activities are performed by different sites then the QP certification site must ensure that the Site of physical Importation is authorised to carry out this activity and hold an MIA that covers Site of Physical Importation activity (MIA, section 2.3.1).

As MIA holders, importers are obliged to comply with Good Manufacturing Practice (GMP) requirements such as establishing a pharmaceutical quality system, have adequate personnel and premises for the activities in question, appropriate arrangements for management of complaints and recalls, and procedures in place to control their supply chains.

A newly defined requirement from March 2021 (section 3.3.2.4 of reference 1) is the requirement for  the site(s) of QP certification of imported products to have a technical agreement in place with the site(s) that is (are) physical importing the product that clearly defines the responsibilities of both parties.

The Quality Technical Agreement (QTA) is a key quality document that is written and approved *between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measure of each party” (ICH definition – Reference 4).  Further guidance on best practice for the generation of QTAs can be found in our previous technical article (Reference 3).

References:

  • EMA/821278/2015 Human Medicines Division European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf

  • EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release

https://ec.europa.eu/health/system/files/2016-11/v4_an16_201510_en_0.pdf

  • MIAS Pharma article – “QTA – Best Practice Design”

https://www.miaspharma.com/qta-best-practice-design/

  • ICH Topic Q 7

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf

You can find more information on our EU QP Batch Release here; https://www.miaspharma.com/eu-qp-batch-release/

If you would like to get in touch with MIAS Pharma, please email info@miaspharma.com or call us on +353 (1) 846 3605.