25 January 2022,   20:42
Additional period for compliance with GMP/GDP standards defined

Timeline for pharmaceutical companies, operating at Georgian market to move to a new quality standard, GMP has been altered. Instead of previously set - January 1, 2022, the companies can shift to a new standard gradually, till the concrete month of the year of 2022 when they have the permission for manufacturing of pharmaceutical products. In parallel, additional benefit has been defined for those manufacturers that have permission till June and they have to get the certificate until June 30.

Minister of Internally Displaced Persons from the Occupied Territories, Labor, Health and Social Affairs of Georgia personally communicated information on setting a transition period to representatives of pharmaceutical associations. As stated by Ekaterine Tikaradze, wholesale distributors will utilize the same benefits.

Participants of the meeting reflected on changes in the field of pharmacy planned for 2022 and aimed at introduction of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.

According to Head of Regulation Agency for Medical and Pharmaceutical Activities, Zaal Kapanadze, the Resolution will be amended and those manufacturers that will fail to comply with GMP standard will still have possibility for exporting medicines.

“The local manufacturers who can’t move to a new standard will have the right to export the products until 2025, since they have already found certain markets in neighboring countries for years”, - said Zaal Kapanadze.

Executive Director of Association of Pharmaceutical Companies, Irakli Margvelashvili positively assessed this initiative and noted that the initiative will support those companies that have willingness and resources for moving to new standard.

“This is an absolutely reasonable and good decision. This decision does not mean rescheduling for those companies that are not willing or are not preparing, but it defines reasonable timelines for the companies who are willing to do so and have corresponding resources available. It is very important, that export is not restricted for local manufacturers whose products are received by the countries based on presented documentation”, - added Irakli Margvelashvili.

During the meeting, First Deputy Minister, Tamar Gabunia announced a new initiative which envisages establishment of Pharmacy Council, which will consider planned changes in the field.