Annex 13

Question 1

What is annex 13

Answer 1

Annex 13: GMP for Investigational Medicinal Products

In August 2015 a consultation on a future IMP GMP Guide stated that Annex 13 would be deleted from
EudraLex Volume 4 and replaced by a separate, stand‐alone GMP guide for IMPs. This proposal was
greeted with universal condemnation by both industry and most EU regulatory authorities.

In December 2017 a revised GMP for IMPs was published. Whilst this revision currently appears in
EudraLex volume 4 underneath the current version of Annex 13 the new document is not titled Annex
13. So, it is unclear what will happen when it is implemented; will it be the new Annex 13, or will it be
published as yet another Part (Part V presumably) of EU GMP? As with the new GMP legislation, the
revised IMP GMP guide will become effective on 31 January 2022 when the CT Regulation 536/2014
becomes effective.

In practical terms the 2017 revised IMP GMP is not very different to the previous 2009 version,
although the labelling requirements in the existing Annex have been removed. Legislation references
have been updated to reflect the new CT and IMP GMP legislation. The content has been re‐ordered
to fit with the order of the chapters in Part I of EU GMP and removes some duplication that was in the
current version by cross‐referencing to either a chapter in Part I or in other Annexes.

There is a new section, Release of Batches that includes expectations for QP certification. This says
that “Assessment by the qualified person of each batch for certification prior to release should take
account of the principles detailed in EudraLex, Volume 4, Annex 16 and may include as appropriate:”

This section includes a list of what the QP should assess prior to certifying batches; these are:
i. Batch records; including deviations or planned changes
ii. Production conditions
iii. Cleaning records
iv. Qualification status of facilities, validation status processes and methods
v. Examination of finished packs
vi. Results of analysis after importation
vii. Stability plan and reports
viii. Source and verification of storage and shipping conditions
ix. Audit reports
x. Certification that export products meet destination country authority requirements
xi. Regulatory requirements are met
xii. Verification of the supply chain
xiii. All factors that are relevant to quality that the QP is aware of