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Revision of the EU GMP Guide – Annex 2

  • 27 August 2018
  • active substance, Annex 2, API, biological, EC, GMP, manufacture, medicinal product, revision,

ASE Pharma Solutions

The revised Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use of the EU GMP Guide came into operation on 26 June 2018. Annex 2 has been revised as a consequence of the adoption of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.

The previous version of Annex 2 included the Advanced Therapy Medicinal Products (ATMPs), however the European Commission has proposed some deletions to this annex consequential to the development of stand-alone guidance for ATMPs. Annex 2 is no longer applicable to Advanced Therapy Medicinal Products.

We have already informed on our website about Guidelines on GMP specific to ATMPs, finalised and published by the European Commission (EC) in November 2017.

In practice, the content of the revised version of Annex 2 – in the context of requirements – has not been changed comparing to the previous version. Current version of Annex 2 simply excludes ATMPs from the scope of the guidelines.

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Where applicable, the new version of annex updates references to current legislation, e.g. under Section 23. – Directive 2010/63/EU on the protection of animals used for scientific purposes vs. Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes as regards requirements for animal quarters, care and quarantine.

We have already informed on our website about this directive and implementation of 3Rs principles, in the context of revision of the guideline on first-in-human clinical trials (FIH CTs).


It should also be noted that the revised Annex 2 emphasizes the importance of traceability (see Section 36.). Traceability for human tissues and cells used as starting materials for biological medicinal products should be maintained from the donor to the batch of a finished medicinal product. Appropriate arrangements should be made between the manufacturer and the supplier of tissues and cells regarding the transfer of health donor information that may become available after the supply of the starting material and which may have an impact on the quality or safety of the medicinal product manufactured therefrom.

Source: EC
Updated: 2018-11-30