The amendment to the Good Distribution Practice – the draft regulation

On April 22nd, 2016 a draft regulation amending the requirements for the Good Distribution Practice of medicinal products (the Regulation of March 13th, 2015 on the requirements for Good Distribution Practice, hereinafter: "GDP") has been published on the Government Legislation Centre’s website. 
The draft regulation provides for, in particular: 
1.    that an entrepreneur will be obliged to ensure a sufficient number of competent personnel (instead of “hiring competent staff”, according to the current wording of the GDP), 

2.    a possibility of appointing a deputy Responsible Person, which is necessary in the event of absence of the Responsible Person due to illness or leave (entrepreneur shall appoint the deputy Responsible Person in writing), 
3.    the unification of provisions regarding requirements for warehouse premises in accordance with EU Guidelines (clear indication that warehouse premises should be separated by walls, ceilings and floors; the rooms used by the employees for a rest, washing and eating should be physically separated from the storage areas), 

4.    amendments in respect to confirming that transport, storage and handling of medicinal products,  have met the special conditions.
It should be emphasized that the draft regulations of GDP does not impose any new obligations on wholesale distributors. 

The draft regulations of GDP is available on the following website address: http://legislacja.rcl.gov.pl/docs//516/12284558/12348632/12348633/dokument217954.pdf