GMP Compliance Adviser Update No. 6/2019

With this GMP Compliance Adviser Update you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP Regulations

Chapter C C.2.1.1 Commission Directive (EU) 2017/1572
C.2.1.2 Commission Delegated Regulation (EU) 2017/1569
C.8.2.1 Safety features for medicinal products for human use Question and Answers – Version 15

GMP Regulations

Chapter C

The following two documents – Directive (EU) 2017/1572 and Regulation (EU) 2017/1569 – will supersede Directive 2003/94/EC which will be repealed according to Article 15, 16 and 17 of Directive (EU) 2017/1572.

C.2.1.1 Commission Directive (EU) 2017/1572

Directive 2017/1572 supplements Directive 2001/83/EG (Art. 40) on the principles and guidelines of GMP. It lays down provisions on inspections by the competent authorities and on certain obligations of the manufacturer.

C.2.1.2 Commission Delegated Regulation (EU) 2017/1569

Regulation 2017/1569 specifies the basic principles of GMP for investigational medicinal products (IMPs) and their monitoring by the authorities. The aim is to achieve a harmonisation of GCP and GMP standards. The document is divided into three chapters:

  • Chapter I General provisions
  • Chapter II GMP (adapted to the EU GMP Guide)
  • Chapter III Inspections

C.8.2.1 Safety features for medicinal products for human use Q&A – Version 15

This documents sets out frequently asked 'questions and answers' regarding the implementation of the rules on the safety features for medicinal products for human use. The changes compared to the superseded version 14 concern the following new or revised questions:

  • New Q&A 3.7
    Who should verify and decommission medicines with safety features that are to be used in clinical trials as investigational medicinal products or authorised auxiliary medicinal products?
  • New Q&A 5.10
    How can a wholesalers be sure that medicines they receive without safety features have been batch released prior to the entry into application of the safety features (9 February 2019)?
  • New Q&A 8.10
    During the transition period, do parallel traders need to decommision the unique identifier on medicines they repackage or relabel for Greece or Italy?
  • Revised Q&A 1.6
    Do the rules on the safety features apply to medicinal products intended for research and development trials?

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