Manufacturing sites abroad that make human medicinal products imported into Türkiye need a TİTCK GMP inspection and certificate. The application is made by the importer established in Türkiye, and every application is a separate procedure with its own fee. An application filed under the wrong type, or a missed deadline, can delay the authorisation timeline by months, and application fees paid are not refunded.
Three application types for three situations
TİTCK’s Guideline on Applications for GMP Inspections of Manufacturing Sites Abroad (İDD-KLVZ-21, Rev. 10, 22.09.2025) groups applications into three types:
| Application type | When? | Certificate validity |
|---|---|---|
| On-site inspection | Sites TİTCK has not inspected on site before; sites where post-inspection changes require an on-site inspection; cases where the conditions for a desk-based assessment are not met | 3 years from the inspection date |
| Desk-based assessment | Requests based on a product TİTCK has already inspected on site and found compliant: other strengths of the same product, other formulations made on the same line and equipment, other lines or activities in the same building, co-marketed products and similar cases | As long as the certificate of the reference product |
| Risk-based assessment | Extending the validity of an existing GMP certificate | 3 years from the expiry of the previous certificate |
Changes to rooms, lines or equipment in the same building at an inspected site are submitted as “GMP notifications”. Annex 11 of the guideline classifies notifiable changes as low, medium or high risk; a high-risk change requires a new inspection application.
Why the type matters so much
The guideline requires applications to follow its provisions and fees to be paid in full; otherwise the application is rejected. TİTCK’s fee tariff states that application fees are not refunded. An application under the wrong type therefore costs more than time: when it is refiled under the right type, the fees are paid again.
Some of the details that drive the choice:
- A desk-based assessment requires the reference product to have been inspected on site by TİTCK and found compliant. Products whose certificate was refused after an on-site inspection cannot be used as the reference.
- Desk-based assessment has two document types with two different fees, depending on whether the site has been inspected before for the company concerned; the fee is higher if the site has not been inspected on site for that company.
- Some routes, such as adding an activity not yet inspected in the same building or manufacture in a different building in a PIC/S country, can be used only if the conditions of the route based on other lines and equipment in the same building are not met. The importer must state in its cover letter which route it relies on.
- A separate application is made for each manufacturing site; one application cannot cover more than one site. Forms are completed separately for each product, site and pharmaceutical form.
- Separate product and certificate fees are paid for each strength and volume of each product.
Timing: the calendar rules
- Priority order. On-site inspections of sites not inspected before are scheduled in the priority order set under the Priority Evaluation Board (ÖDEK) guideline, and the ÖDEK decision is submitted with the application. Under the scheduling guideline, MA applications for products that ÖDEK has prioritised for inspection are assessed without a TİTCK GMP certificate. GMP and MA planning should therefore go hand in hand.
- Adding products to, or removing them from, a scheduled inspection. These requests must be made at least 15 working days before the inspection date, because they affect the scope and the number of inspection days.
- The risk-based window. A risk-based application can be made at the earliest 6 months before the certificate expires. Given the application, assessment and certification time, applying at the start of this window saves time.
- The limit on risk-based extensions. The longest validity of an inspection is 12 years for sites in PIC/S member countries (3 risk-based applications; this applies to applications based on on-site inspections carried out in 2016 or later) and 9 years for others (at most 2 risk-based applications). When these are used up, a desk-based application is made if the conditions are met, otherwise an on-site inspection application. For products that are to be inspected on site, or that have used up their extensions and cannot meet the desk-based conditions, an existing certificate can be extended once by up to 12 months if a current GMP certificate issued by a PIC/S authority is submitted.
- A negative outcome. If an on-site inspection finds a critical deficiency, or enough major deficiencies to count as critical, the certificate is refused. No new on-site application is accepted for 6 months from notification of the result, and the inspection fees are paid again for the next inspection.
Every step has its own fee
TİTCK’s fee tariff lists each step of the GMP procedure for sites abroad as a separate item:
- On-site inspection application (one site per application)
- On-site site inspection (per site) and on-site product inspection (per product, per site)
- Desk-based assessment (per product, with two separate items depending on whether the site has been inspected before for the company)
- Risk-based assessment (per site, per product)
- GMP certificate, replacement certificate and certificate annotation
- Missing documents application and GMP notifications
Because submitting missing documents is a separate item in the tariff, an incomplete file generates a new fee when it is completed. Every later notification and certificate annotation is charged separately. If TİTCK needs to inspect a site during the certificate’s validity because of product complaints or quality defects, the company pays for that inspection too. Under the tariff, any duties due under the Law on Fees are paid separately. Current amounts are published in the fee tariff TİTCK issues each year.
Example: for an on-site inspection of a site TİTCK has not inspected before, covering one product in two strengths, the company pays the application fee, the site inspection fee, a product inspection fee for each strength and a certificate fee for each strength; the site inspection is the largest item. If a third strength of the same product is added later, the desk-based assessment and certificate fees are paid separately.
Applications now go through the Z-Denetim Portal
Since TİTCK’s Z-Denetim Portal application guide for company users took effect on 30 April 2026, company applications for GMP inspections of sites abroad are made through the Z-Denetim Portal. Users log in with their EBS credentials and a verification code sent by email. The application covers the form for the inspection type, the site, the products, the authorised person and the payment details; the fee is calculated by the system and paid with a reference number specific to the application. The guide is inconsistent on whether a submitted form can be changed: the submission prompt warns that it cannot be changed once submitted, while an information note says the relevant fields can be edited until the application is approved. Checking the type, site and product selection before submitting therefore matters as much on the portal as it did on paper.
What works in practice
- One table, drawn up while planning the MA, showing which site will be inspected for each manufacturing step and under which application type
- Clarifying the site’s TİTCK inspection history (which product, which date, which certificate) with the manufacturer before applying
- Checking from the start that technical documents and forms are prepared by the manufacturing site and signed by its responsible persons
- Tracking all GMP certificates in the portfolio in one calendar, with expiry dates and remaining risk-based extensions
From choosing the application type and ÖDEK applications to preparing the file with the manufacturer and tracking certificate validity, we at Melvin International Consulting would be glad to give you the most professional support with GMP inspections of sites abroad. See our GMP Inspections service or get in touch.
Sources: TİTCK Guideline on Applications for GMP Inspections of Manufacturing Sites Abroad (İDD-KLVZ-21, Rev. 10, 22.09.2025), Sections 7, 8 and 11; TİTCK fee tariff; TİTCK guideline on scheduling of MA applications (İRD-KLVZ-22, Rev. 4, 04.06.2026), Art. 5; Z-Denetim Portal application guide for company users (April 2026). This article is for general information only; current legislation and TİTCK announcements prevail.
