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TİTCK Publishes Guidelines for Mutual Recognition Regarding Pharmaceutical Inspections

Legal Alerts
Healthcare
General

Recent Developments

The Turkish Medicines and Medical Devices Agency (“TİTCK”) published the Guidelines for Mutual Recognition Regarding Pharmaceutical Inspections on July 9, 2019 (“Guidelines”). The Guidelines sets forth the procedures and principles for health authorities’ mutual recognition applications with the TİTCK regarding Good Manufacturing Practices (GMP) inspections.

What’s New?

As per the Guidelines, the following health authorities may apply to the TİTCK for mutual recognition: supervisory/regulatory health authorities in the countries where (i) the manufacturing facilities that obtained an activity permit from the TİTCK to produce pharmaceuticals and their active substances are located; and (ii) companies that have licensed medicines or ongoing licensing processes are located. Health authorities can also make their mutual recognition applications via trade unions or associations that pharmaceutical companies operating in Turkey or that have representative agencies in Turkey are members of.

The TİTCK will evaluate each health authority’s application for mutual recognition extensively and separately. Accordingly, the TİTCK will assess the applicant health authorities’ legislation on GMP, quality system, GMP inspection processes, inspector qualifications, conflict of interest policies, GMP compliance level of manufacturing facilities in the country, market control programs and other relevant regulations and procedures.

The Guidelines are available on the TİTCK’s website (in Turkish).

Conclusion

Mutual recognition agreements regarding GMP inspections are of great importance to decrease technical difficulties in pharmaceutical trade and lift limitations on pharmaceutical companies’ accesses to foreign markets. Accordingly, the TİTCK continues to take regulatory steps regarding GMP inspections of pharmaceutical companies. In this respect, the TİTCK will be able to conduct GMP inspections in the manufacturing facilities in the country of the relevant health authority with which the TİTCK has a mutual recognition agreement.