7 November 2026 · Melvin Consultancy

Getting a marketing authorisation is not the end of the job. At the end of the first five years the MA must be renewed, and for products made abroad the manufacturing site’s GMP certificate must stay valid without interruption. Both timetables are tight, and being late can end in suspension of the MA.

MA renewal: nine months before the fifth year

Under Article 21 of Türkiye’s Regulation on the Marketing Authorisation of Human Medicinal Products, the MA is re-evaluated on its benefit/risk balance five years after it was granted. The MAH must submit a file containing up-to-date efficacy, safety and quality information, pharmacovigilance data and all variations since authorisation nine months before the five-year period ends. Once renewed, the MA is valid indefinitely unless TİTCK requires a further renewal on pharmacovigilance grounds.

In TİTCK practice, what must be completed before the file is just as decisive:

  • SmPC/PIL must be confirmed as up to date first. An SmPC/PIL currency application must be approved before the renewal is submitted; an undertaking is not accepted. The timeline for this approval is 60 days.
  • Quality data is not updated during renewal. Module 3 changes must be completed beforehand through variations. If variations affecting the MA certificate annex (such as manufacturing, packaging or batch release sites) are still under review, the renewal cannot be submitted until they are concluded.
  • Commitments must be closed. Process validation and stability data committed at authorisation must be submitted in full, together with a list of all variations approved since authorisation and their approval letters.

GMP certificate: a three-year cycle

For manufacturing sites abroad, the GMP certificate TİTCK issues after an on-site inspection is valid for 3 years from the inspection date. It can be extended by 3 years at a time through a risk-based inspection application, which may be filed no earlier than 6 months before expiry. Missing that six-month window puts continuity of the certificate at risk.

A single on-site inspection can be relied on for up to 12 years for sites in PIC/S member countries and 9 years elsewhere. After that, a new on-site or desk-based inspection is needed. Because a new on-site inspection takes time to schedule, that date also needs to be tracked well in advance. If an on-site inspection triggered by a risk-based review finds a critical deficiency, the certificate is cancelled and imports of the product are stopped.

The cost of being late

  • Suspension and cancellation: Article 22 of the Regulation lists failure to update the SmPC/PIL and loss of validity of documents submitted in the application among the grounds for suspending an MA. If the ground for suspension is not resolved within six months, the MA is cancelled and manufacture or import of the product stops (Art. 23).
  • No transfers: an MA that has not been renewed cannot be transferred (Art. 26). If a portfolio sale or merger is on the table, renewal status directly affects the deal.
  • Supply interruption: imports stop when a GMP certificate is cancelled, and an expired certificate likewise puts imports at risk, which can leave the market out of stock.

A practical timeline

The renewal deadline is nine months before the fifth anniversary. Allowing for SmPC/PIL approval and pending variations, we recommend starting at least 12 months ahead. On the GMP side, the application window opens six months before expiry, and up-to-date documents from the manufacturer should be in hand by then. Tracking every MA and certificate date in the portfolio in one calendar is the simplest way to avoid surprises.

From setting up a portfolio calendar and preparing renewal files to keeping SmPC/PILs current and renewing GMP certificates on time, we at Melvin Consultancy would be glad to give you the most professional support at every step. See our Marketing Authorisation Renewal and GMP Inspections services or get in touch.

Sources: Regulation on the Marketing Authorisation of Human Medicinal Products (consolidated, 30.12.2025), Articles 21, 22, 23 and 26; TİTCK Marketing Authorisation Department FAQ (16.02.2024); TİTCK Guideline on Applications for GMP Inspections of Foreign Manufacturing Sites (İDD-KLVZ-21), Rev. 10, 22.09.2025. This article is for general information; current legislation and TİTCK announcements prevail.