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

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

 

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