The Turkish Pharmaceuticals and Medical Devices Agency
("Agency") published the Communiqué on
Manufacturing Sites of Dietary Foods for Special Medical Purposes
in Official Gazette number 29474 on 13 September 2015
("Communiqué"). The Communiqué outlines
principles and procedures for sites which manufacture dietary foods
for special medical purposes, including processes for licensing and
Significant provisions in the Communiqué include:
Dietary foods for special medical
purposes (including those intended for export) can only be
manufactured at sites which hold a manufacturing site license from
the Agency. Annex I of the Communiqué lists the information
and documents required during license applications. The Agency will
verify the application information's accuracy and grant
licenses to qualifying applicants within 90 days. Agency
supervisors will later carry out site inspections to determine
whether the applicant's manufacturing site meets the necessary
licensing conditions (Article 5).
License holders for manufacturing
sites must (Article 6):
Employ appropriate personnel for
production, quality control, storage and distribution
Dispose of unusable products in
accordance with legislation.
Inform the Agency beforehand if the
information and documents change from those which were presented
during the initial license application.
Immediately appoint a new responsible
manager and inform the Agency if the current responsible manager
resigns or cannot carry out his/her duties.
Allow Agency supervisors to enter the
necessary parts of the premises to conduct examinations.
Supervisors must present their certificates of authorization during
Provide all necessary opportunities
for the responsible manager to carry out his/her duties.
The manufacturing site holder must
permanently appoint a responsible manager who meets the criteria
specified under Article 7.
The Agency must supervise licensed
manufacturing sites within a set supervision framework, as well as
in any other situation it considers necessary (Article 8).
Manufacturing sites must operate in
accordance with the "Good Manufacturing Practice
Principles", outlined in the Communiqué. These address
personnel, equipment, premises, manufacturing, quality control,
documentation and toll manufacturing (Article 9 and
The Communiqué enters into effect on 13 September 2015
and is overseen by the Head of the Agency. For applications made
before the Communiqué's effective date, the relevant
legislation in force at the application date will be applied.
Please see this link for the full text of the Communiqué
(only available in Turkish).
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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