Additional measures for GMP inspections taking place overseas and certification process to be implemented during the pandemic

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The obligations of importing companies arising from the applicable legislation regarding the products for which they have a marketing authorization / have applied for a marketing authorization are still binding, due to the ongoing precautions and restrictions linked to the conditions of sale. pandemic in the world and in our country, provided that MMDA reserves the right to inspect the relevant facilities at any time, the following measures have been taken by MMDA regarding GMP inspections in overseas production facilities and certification process until the end of pandemic measures and restrictions:

1. Due to the impossibility of carrying out on-site GMP checks abroad since the pandemic-related measures and restrictions, the validity periods of GMP certificates, the validity periods of which have been extended until 31 December 2021, have been extended until December 21, 2022 without the requirement of an application by the importing companies.

1.1. The validity period of the GMP certificates of the products for which a request for inspection (renewal) based on the risks was made before the GMP certificate, and of the products for which the inspectors of the establishment made an inspection decision on place, and products for which GMP certificates have been previously issued by a request for inspection (exemption) on the file compiled concerning these products have been extended until December 31, 2022, without a request from the importing companies being necessary.

1.2 The validity period of the GMP certificates of the products for which the validity period of the certificate will expire in 2022 from December 31, 2021, and the products for which the establishment’s inspectors have made an on-site inspection decision due to GMP risk- based on inspection (renewal), and products for which GMP certificates were previously issued through a request for inspection (exemption) on the dossier compiled for these products have been extended until at 31.12.2022.

1.3 The validity period of the GMP certificates of the products which are not entitled to apply for risk-based inspection (renewal) for the third time in accordance with the relevant article of the “Guidelines on applications for GMP inspections of the Overseas Manufacturing Sites”, the products whose validity period of the GMP certificate will expire before December 31, 2022, and the products for which the GMP certificate has been issued before, through the application for inspection (waiver) on the dossier made concerning these products, have been extended until 31.12.2022 without the need for an application by the importing companies.

2. For facilities previously inspected by the MMDA, requests should be made under Section B of the “Guidelines on Requests for GMP Inspections of Overseas Manufacturing Sites”.

3. For facilities that MMDA has not inspected before, provided that MMDA reserves the right to inspect affected facilities during and after the pandemic, provided that high priority products a high priority decision and a priority decision with the decision of the Priority Review Committee to have been inspected by a PIC/S member authority, for these products; in cases where the criteria determined in article B of the Guidelines on applications for GMP inspections of foreign manufacturing sites are not met, an exceptional inspection on file will be carried out; the documents to be submitted are specified in the advertisement.

4. In Section C (General Principles of Risk-Based Inspection) of the Guidelines on Requests for GMP Inspections of Overseas Manufacturing Sites, the statement “Requests for risk-based inspections will be made 9 months before the expiry of the validity of the certificate of the product concerned” is included. However, in cases where importing companies encounter difficulties in obtaining documents from production sites due to the pandemic, requests for inspection based on the risks can be made up to 6 months before the expiry of the period of validity of the certificate of the product concerned.

5. In the event of difficulties in obtaining documents from production sites by importing companies due to the pandemic; provided that a letter of commitment with the document type “Notification” is given on the EBYS system that the originals of the documents will be delivered by the importing company as soon as they are provided, provided that the name of the importing company , the product name and electronic tracking number of the application of documents to be sent from overseas production locations are specified, it can be sent by email to “[email protected]“.

6. Regarding applications for a certificate to extend the validity period of certificates issued after an application made under Article B (desk inspection) of the Guidelines on applications for GMP inspections of manufacturing sites at foreign, provided that the reference product has been inspected under the name of another company and a request for risk-based inspection has not been submitted for the reference product, to extend the period of certificate for the product of the other company (not inspected), an application can be made 6 months before the expiry of the certification period for this product, within the framework of article C of the guide mentioned (inspection based on the risks).

NATIONAL PRODUCTION FACILITIES GMP CERTIFICATES

With MMDA’s announcement on the subject dated February 08, 2021, it was clarified that the validity period of GMP certificates of facilities for the production of medicinal products for human use, whose last general inspection expired three years and whose certificates have expired, has been extended until December 31, 2021.

Due to the current fight against the pandemic, it has been decided to carry out general inspections in the second half of 2021, and inspections have been launched within this framework, taking into account the commitment to the standardization process in accordance with the circular on Normalization measures for June as of June 1, 2021.

In this process, the period of the GMP certificate has been extended up to December 31, 2022, for facilities that have passed three years since the last general inspection, and certificates have expired so as not to delay national and international applications from domestic pharmaceutical manufacturers whose inspection has not yet been carried out. For facilities whose general inspection has been/will be carried out in 2021, an assessment will be made on the date of the inspection, and a certificate will be issued if GMP compliance is found according to the results of the general inspection report.

National facilities whose certificate period has expired should submit an application to the Department of Drug Inspection, National Facility Inspection Enforcement and Follow-up Unit, in the document type “GMP Certificate (for domestic production facilities Turkish and English)”.

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