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Parliamentary questions
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23 November 2018
E-004700/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-004700/2018

Two Commission guidelines establish the requirements of Good Distribution Practice (GDP) for Medicinal products and their active substances.

The Commission guidelines on GDP of medicinal products for human use, were first published in 1994 and revised in 2013 to take into account recent advances in appropriate storage and distribution practices. The guidelines are applicable since 24 November 2013(1).

In 2015, a second set of guidelines were published on principles of GDP of active substances for medicinal products for human use for importers and distributors of active substances for medicinal products for human use. The guidelines are applicable as of 21 September 2015(2).

The Commission believes these two sets of guidelines are up to date and do not need to be amended in the near future.

Although the Commission has not conducted any specific studies on the practical implementation of the GDP guidelines by Member States, the Commission and the European Medicines Agency hold regular meetings with competent authorities where GDP in the EU is often discussed(3).

(1)Guidelines on Good Distribution Practice of Medicinal Products for Human Use.
(2)Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use.
(3)https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice

Last updated: 26 November 2018Legal notice