As of the decision of Georgian Government, switching to the Good Manufacturing Practice (GMP) standards should become mandatory for pharmaceutical companies from 2022.
However, in October 2020, the Pharmacists Association addressed the Prime Minister and asked to delay implementation of world standards until 2027.
Levan Gogiberidze, President of the Pharmacists Association told BM.GE, that the sector is asking a reasonable time for switching to GMP standards, which should be considered individually for each company.
“Unfortunately, any required time cannot become a prerequisite for the company to continue operating with GMP standards, taking into account their financial resources. We are talking about an individual approach to those 7-8 manufacturers who have already taken effective steps in this direction and plan to invest up to 70 million GEL in the future, but will need additional time before the final introduction of the standard”, Levan Gogiberidze says.
The President of the Pharmacists Association declares that their opinion is based on international practice and implies that each manufacturer will be able to meet international requirements on an individual schedule. The individual schedule will depend on the manufacturer's current condition in terms of GMP standards and it must amount 2-3 years on average.
“This was discussed at a meeting with business associations, and the Prime Minister told us that he was aware of the case. We are waiting for the results, "Levan Gogiberidze said.
According to him, the Ministry of Finance and the Ministry of Economy are actively involved in the process jointly with the Business Ombudsman, which supports the sector. While the Ministry of Health is more conservative in its approaches.
"As a result of communication with the Business Ombudsman, we know that the issue has reached a legal solution, therefore we believe that the issue of switching to the GMP standard from 2022 should be resolved in the near future," - said Levan Gogiberidze.
