May 10, 2017
Keeping at par with industry trends and following the European Union directives, Turkey has recently introduced a new regulation on packaging, inserts and tracking of pharmaceuticals. On April 25th, 2017, the Turkish Ministry of Health published the Regulation on Packaging Information, Inserts and Tracking of Medicinal Products for Human Use in its Official Gazette. The Regulation on Packaging and Labeling of Human Medicinal Products published on August 12th, 2005, has been hereby revoked. Overall, the new regulation is said to be governing the requisite information on packaging inserts of medicinal product for human use and principles as to the type of notifications to be made by sellers or importers for tracking of the pharmaceutical distribution chain.
New Regulation Transition Process
Guiding the industry to fall in compliance, the Turkish MoH has granted the following transitional periods for fulfilling the requirements under the Regulation:
- Beginning 9/30/17 – Medicinal products for human use that are licensed or permitted or subject to license/permit application before the enforcement of the Regulation must be made compliant with packaging and insert requirements
- For medicinal products for human use manufactured before December 31st, 2017, current packaging can be preserved until the expiration of their shelf life
- Medicinal products for human use manufactured after December 30th, 2017, packaging and direction requirements of the new Regulation should be fulfilled.
- By 12/31/18: Foods for special medical purposes that are not reimbursed but brought under the scope of Data Matrix practice as per Article 5 of the Regulation should participate to the Data Matrix practice
- By 12/31/18: Bulky parenteral, radiopharmaceuticals and individualized human medicinal products should participate to the Data Matrix practice
With the transition process timelines announced, it’s time to decode the regulatory requirements that have been made mandatory in case of packaging and tracking of human medicinal products. On a higher note, brief below are some of them.
- Interior/ Exterior Packaging and Directions for Use
- Marketing Samples
- Tracking of Human Medicinal Products
In today’s increasingly globalized world, the packaging industry needs to constantly upgrade itself to match the international standards and quality. The traditional packages available do not serve the purpose of providing protection against counterfeiting and quality, and the industry seems to be sluggish in adopting advanced technologies in packaging, probably because of the cost factor. As packaging industry, sometimes, is directly involved in the drug manufacturing process, it becomes ethically mandatory to understand and incorporate the upgraded requirements during the process. To understand the scope of the latest regulations and keep at par with latest trends, a Regulatory industry expert proficient in this field of work might come handy. Get in touch with them at the earliest to be compliant.
