It’s almost eight years since the new revision of Annex 16 of the EU GMP Guide: Certification by a Qualified Person and Batch Release, came into effect on 15th April 2016. It was introduced due to the increased complexity of global supply chains as it was felt that the previous guidelines, relating to batches manufactured either partly or fully outside the EU/EEA had become open to interpretation. The revision of Annex 16 in 2016 sought to address this.

Section 1 of the Annex describes the process of EU QP batch certification and applies to all medicinal products (human and veterinary) intended to be released for EU markets, or for export outside of the EU to the rest of the world.  Irrespective of the complexity of your supply chain and the global locations of your manufacturing sites involved, Annex 16 of the EU GMP guide will apply where your product has touched down in the EU for release or for onward export.

International Harmonisation

  • Roll forward to February 2022 and it wasn’t until this time that Annex 16 of the EU GMP was adopted internationally by PIC/S and its member countries as a completely new addition to the PIC/S GMP guide. Initially it was felt that the 2016 revision of Annex 16 of the EU GMP was too EU specific and the PIC/S GMP Guide was limited to the manufacture of medicinal products and not the import and distribution activities described in EU GMP Annex 16.
  • The adaption by PIC/S of EU GMP Annex 16 supports better harmonisation of GMP standards at an international level with the aim of having non-EU/European Economic Area (EEA) members incorporate EU GMP Annex 16 into their regulatory systems. The terms, interpretation, and application of PIC/S GMP with regards to EU GMP Annex 16 requirements have been kept standardised, however you will not see the EU term of “Qualified Person” but instead the PIC/S term of “Authorised Person” which should be treated as equivalent.
  • With regards to the requirements for importation (for non EU/EEA countries) detailed in Annex 16, PIC/S have agreed that this is voluntary for the participating countries and will depend on the national law within the country.

Batch certification and release

So let’s remind ourselves of the three stage process of EU QP certification and batch release as defined by Annex 16 of EU GMP Guide:

qp certification stages

Stage 1

Checks of the manufacture and testing of the batch in accordance with defined release procedures.

To note, for products manufactured outside the EU, physical importation and QP certification are considered to be the final stages of manufacturing which precede the transfer to saleable stock in the EU, or for export.

Stage 2

EU QP certification of the finished product batch signifying that the batch is in compliance with GMP and the requirements of its Marketing Authorisation (MA) or Clinical Trials Authorisation (CTA)

Certification can only be performed by a QP of the EU manufacturer and/or importer which are described in the MA or CTA.

Stage 3

The transfer to saleable stock for the EU market and/or export to the rest of world after certification by the EU QP.

Rest of the world releases

Sometimes the question arises regarding the certification of batches which have their final production step within the EU but are not marketed in the EU and whether certification to the MA / CTA is needed or if the issuance of QP GMP Statement is sufficient.

EU law does not distinguish between manufacture for EU and manufacture for export. Both types of products will require a manufacturing authorisation and the QP should be satisfied that third country market requirements are known and are being compiled with to allow certification in accordance with Annex 16.

After EU QP certification and export from the EU the medicinal products may be subject to additional requirements as defined in the national laws of the importing country.

The EU/EEA have a number of Mutual Recognition Agreements (MRAs) with the following countries: Australia, Canada, Israel, Japan, New Zealand, Switzerland and USA.  Some of these MRAs allow the recognition and acceptance of each other’s batch certification. It is important that the details of individual MRAs are checked to determine what is in scope or out of scope (i.e. that acceptance of batch certification is allowed, and which product types are covered or excluded).

With regards to releases to the UK, which is now outside of the EU/EEA, the UK will accept EU QP certification of products with a UK or Great Britain marketing authorisation that are imported into Great Britain by a wholesaler dealer after checks have been carried out by the Responsible Person for Import.

How MIAS Pharma can help?

MIAS Pharma is a QP batch certification site holding an MIA for both Marketed and IMP products. We partner with our clients to provide practical and innovative solutions for batch release into the EU and rest of the world.

Find more information related to  Annex 16 of EU GMP Guide: https://www.gmp-compliance.org/guidelines/gmp-guideline/eu-gmp-annex-16-certification-by-a-qualified-person-and-batch-release

Read more about our Clinical QP services or reach out to us here.

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