28/29 September 2021
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.
Status of Implementation of EU GDP Guidelines
How is it implemented
What are the requirements to become a Responsible Person (RP)
|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|