Turkey has amended rules for production, export, import, use, packaging and sale of veterinary medicinal products. Notably, the transition period’s deadline for adapting veterinary products and production sites to meet good manufacturing practices has now been extended from two to five years.
The Regulation Amending the Regulation on Veterinary Medicinal Products (“Amendment Regulation”) was published in Official Gazette number 30277 on 21 December 2017, entering into effect on the same date.
Notable changes under the Amendment Regulation include:
- The transition period, which is an extension to the deadlines set forth by the Regulation, for product owners that have ongoing transactions which began before 24 December 2011 (the enforcement date of the Regulation on Veterinary Medicinal Products) has been extended from two to five years.
- The additional one year period granted after notification of deficiencies continues unchanged. However, the prohibition on production and import of veterinary medicinal products within this year has been removed.
- Transition periods for the following products have has been extended to 24 December 2019:
- Potash alum.
- Sheep and goat pox.
- Sheep and goat pestis.
- Blue tongue disease vaccines and test antigens.
Please see this link for full text of the Amendment Regulation (only available in Turkish).
Information first published in the MA | Gazette, a fortnightly legal update newsletter produced by Moroğlu Arseven.