Current Status of GDP Implementation and the Role of the RP - an Overview

Recommendation

14-16 May 2025
Vienna / Schwechat, Austria

GDP for Beginners
Two-day training + 1-day Airport tour at Vienna Airport in cooperation with DHL

In 2013 the ECA Foundation established the GDP Interest Group with the goal to support all stakeholders involved in Good Distribution Practice (GDP) by providing them with information about the implementation of GDP.

For that purpose the Interest Group joined forces with the Pharmaceutical Quality Group (PQG) to develop an interpretation of the EU Guide on Good Distribution Practices which was published in a revised version in 2013. These interpretations can be downloaded chapter by chapter in the GDP Group Website members' area.

To find out where the EU GDP Guidelines have been implemented already as a national rule and where they are still Guidelines or possibly have another status the group set up a survey amongst its members. Here is a summary of the feedback. More details can be found on the website of ECA's GDP Working Group. Please note that this summary was done based on the feedback of the participants. ECA is not responsible for the accuracy of the information provided. If you have new information about the current status in your country please let us know in order to update the table.

Country	Status of Implementation of EU GDP Guidelines	How is it implemented	What are the requirements to become a Responsible Person (RP)	Official Authority
Austria	Implemented completely	integrated in the national regulations	University degree in pharmacy, medicine, chemistry, biology or similar. 2 years relevant working experience. (AMBO §7)	AGES
Belgium	Implemented completely	Official translation has been implemented	no info	FAGG
Bulgaria	in process of implementation	ongoing		Bulgarian Drug Agency
Denmark	Implemented completely	integrated in the national regulations	Preferably a pharmacist	DMA
France	Implemented completely	integrated in the national regulations	As defined in EU GDP Guidelines	ANSM
Germany	Implemented completely	Official translation has been implemented	According to EU-GDP-Guide. A degree in pharmacy is not a must. The Responsible Person should have appropriate experience as well as knowledge of and training in GDP.	Local (federal) competent Authority
Hungary	Implemented completely	integrated in the national regulations	Pharmaceutical degree	NIP
Ireland	Implemented completely	integrated in the national regulations	As defined in EU GDP Guidelines	HPRA
Lithuania	Implemented completely	Official translation has been implemented	Pharmaceutical degree	State Medicines Control Agency
Malta	Implemented completely	Official translation has been implemented	Pharmaceutical degree	Medicines Authority of Malta
Netherlands	Implemented completely	integrated in the national regulations	Preferably pharmacist	IGZ
Norway	Implemented completely	Official translation has been implemented	no info	Norwegian Medicine Agency
Poland	in process of implementation	ongoing		Main Pharmaceutical Inspectorate
Romania	Implemented completely	integrated in the national regulations	Pharmaceutical degree, at least 2 years of experience in GDP/GMP	National Agency for Medicines and Medical Devices
Spain	Implemented completely	Official translation has been implemented	The same as a QP(Pharmacist degree or equivalent) plus specific courses in GDP	AEMPS
Switzerland	Implemented completely	integrated in the national regulations	Pharmacist, but other qualification may be accepted by Swissmedic based on education and experience	Swissmedic
U.K.	Implemented completely	integrated in the national regulations	As defined in EU GDP Guidelines	MHRA