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Legal Alerts

December 26, 2016

Turkey Revises GMP Certificates for Medicinal Products for Human Use

Legal Alerts
Healthcare

Recent Development
The Turkish Medicines and Medical Devices Agency (the “TİTCK”) announced that the Good Manufacturing Principles (“GMP“) certificates given for local production sites of medicinal products for human use have been revised.

Background

GMP is a set of standards to ensure that the production and quality control of medicinal products are conducted in compliance with quality standards and their intended purpose of use. GMP provides certain measures to be taken with respect to production processes, production sites, proper equipment and storage. Producers of medicinal products for human use in Turkey should obtain a GMP certificate issued or approved by the Department of Medicine Inspection, which operates under the TİTCK.

What the announcement says

The TİTCK announced that the GMP certificates for medicinal products for human use have been revised and it has provided revised versions of two types of certificates; type 1 for production sites and type 2 for manufacturers.

In addition, the TİTCK advises local producers to take note of certain issues in their applications for GMP certificates, including the following:

  • the scope of activities indicated in the license documents and the GMP certificates should be the same;
  • an additional explanation of the scope of activities should be provided in the application for type 1 certificates, if necessary; and
  • reasons for applying for type 2 certificates should be indicated in the application. The TİTCK continues to provide producers of medicinal products for human use with detailed information and guidelines regarding GMP certificates.

Conclusion

Applicants for GMP certificates should take note of the revised version of the certificates as well as the requirements announced by the TİTCK, and should follow any further announcements made on the TİTCK’s website