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EU GMP Guide – Annex 21: Importation of medicinal products

  • 23 апреля 2020
  • Annex 21, GMP, IMP, import, investigational medicinal product, medicinal products, QP, QP certification, QP confirmation,

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Update [21/03/2022]

On 21 February 2022, the European Commission (EC) has published a final version of the new Annex 21: Importation of medicinal products of the EU GMP Guide.

This new annex comes into operation on 21 August 2022.



Due to the challenges posed by COVID-19, the timeline for the targeted consultation has been extended until 20 August 2020.


On 20 March 2020, the European Commission (EC) released for 3 months consultation (till 20 June 2020) a draft version of Annex 21: Importation of medicinal products of the EU GMP Guide.

GMP cerifie

The importation of medicinal products is, in light of Article 40(3) of Directive 2001/83/EC, subject to GMP requirements. In addition to the guidance given in the main chapters and annexes of the EU GMP it has become necessary to publish a specific guideline clarifying the application of the principles of GMP in the activity of importation of medicinal products under Annex 21 of the GMP guideline.

This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (MIA) holder which imports medicinal products (human and veterinary) from outside the EU/EEA.

The draft document is establishing a common understanding of the term importation which is defined as the action of physically bringing medicinal product, from outside the territory of EEA/EU. The sites which are considered to have specific importation responsibilities in relation to a medicinal product or imported dosage form are:

  • Site of Physical Importation;

  • Site of QP certification of imported medicinal products or QP confirmation for intermediate products undergoing further processing, as appropriate.

This document describes GMP requirements for the following areas:

  • Pharmaceutical Quality System;
  • Premises and equipment;
  • Documentation;
  • Operations;
  • Complaints, Quality Defects and Product Recalls.

Source: EC