Business and public representatives supported the most of the Better Regulation Delivery Office (BRDO) proposals regarding improving the draft license conditions on pharmaceutical products manufacture, trade and import.
Particularly, BRDO experts proposed to exclude unclear provisions that “license holder must provide getting of the documentation including the one, which is being sent by licensing authorities” from the draft document.
Also, it was proposed to elaborate those proposals, which do not have clear requirements. For example, there is a requirement for a license holder to “provide permanent staff training”.
“We must clearly establish time frames and frequency of staff trainings carried out by a license holder,” the BRDO expert Leonid Lytvynenko said.
Or it can be a requirement for the executive staff “to work on a full-time basis”. BRDO experts proposed to point out that senior staff should work in pursuant to the internal labor policy and labor legislative requirements”.
Roundtable participants paid attention to the fact that license provisions must be framed with the fullest and clearest list of their quantitative and qualitative characteristics, which are important, as questionable and not specific terms create possibilities for the abusive practice during inspections”.
The BRDO Market Surveillance Sector Head Volodymyr Holovatenko pointed out that establishing obligations to perform a vague number of legal provisions in license conditions are inadmissible: “A full list of information (a data) that should be included to the document details and its form must be determined by license conditions”.
The discussion of qualification requirements for heads of pharmacies in small towns and villages also was lively. According to the draft license conditions, the requirement of having less than two years of work experience just like for the heads of pharmacies in large towns doesn’t extend to them. Professional associations’ representatives suggested to save this provision, otherwise it will be difficult to find the personnel for pharmacies in small towns and villages.
Agreed proposals received from roundtable participants will be considered and included to the BRDO conclusions and submitted to the State Regulatory Service of Ukraine and the Ministry of Economic Development and Trade of Ukraine.
It is to be reminded that the draft regulation “On approval of license conditions on economic activities in the pharmaceutical products manufacture, pharmaceutical products wholesale and retail selling, pharmaceutical products import (except Active Pharmaceutical Ingredients)” was developed by the State Administration of Ukraine on Medicinal Products.