We manage the five-year renewal of your human medicinal product marketing authorisations from start to finish and prepare the renewal file on time and in full. By tracking the validity of MA-related documents and GMP certificates in the same calendar, we help keep your products on the market without interruption.
- A single calendar for MA dates, renewal deadlines and GMP certificate expiry dates across the portfolio
- Pre-renewal gap analysis: SmPC/PIL currency, pending variations and commitments made at authorisation
- Preparation of the SmPC/PIL currency application and follow-up of its approval
- Preparation of the quality overall summary and the list of variations approved since authorisation, with approval letters
- Compilation of efficacy, safety and pharmacovigilance data for the renewal file
- Coordinating renewals of co-marketed products with the main product
- Submission via TİTCK’s electronic application system (EBS), responses to requests for information and follow-up
- Timely risk-based GMP inspection applications for manufacturing sites abroad
- Checking renewal status ahead of MA transfers and portfolio transactions
Frequently Asked Questions
When is an MA renewed?
Under Article 21 of the 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 submits a file with up-to-date efficacy, safety and quality information and all variations since authorisation nine months before the five-year period ends.
How long is a renewed MA valid?
Once renewed, the MA is valid indefinitely. TİTCK may, however, decide on one further five-year renewal on pharmacovigilance grounds, such as exposure of an insufficient number of patients. For products not yet placed on the market, the assessment is based on the pharmacovigilance data available.
What must be completed before applying for renewal?
An SmPC/PIL currency application must have been submitted and approved; renewal cannot be applied for on the basis of an undertaking, and the timeline for SmPC/PIL approval is 60 days. Variations still under review that affect the MA certificate annex (such as changes to manufacturing, packaging or batch release sites) must also be concluded first. We therefore recommend starting at least 12 months ahead.
Can quality data be updated during renewal?
No. Module 3 quality data is not updated during renewal. Because the MAH must keep this data current at all times, changes must be completed through variations before the quality overall summary is submitted.
What goes into the quality overall summary?
A list of all variations approved since authorisation or the last renewal, with TİTCK’s approval letters. Process validation and stability data committed at authorisation must also be submitted in full; undertakings are not accepted at this stage. For biological, biotechnology, biosimilar, blood products and vaccines the submission goes to the Biological and Biotechnological Products Unit; for other products to the Authorised Medicines Technical Assessment Unit.
How are co-marketed products renewed?
Renewals of co-marketed products are also due nine months before the five-year period ends. A separate quality overall summary approval is not needed; the main product’s quality overall summary approval or renewal approval letter is submitted.
Can an MA that has not been renewed be transferred?
No. Under Article 26 of the Regulation, an MA that has not been renewed cannot be transferred. If a portfolio sale or merger is planned, renewal status should be checked in advance.
How are conditional MAs renewed?
A conditional MA is valid for one year and re-evaluated annually. The MAH applies for renewal at least 90 days before expiry, with an interim report on the specific obligations. If the application is made on time, the product may stay on the market until TİTCK’s decision, which is issued within 90 days.
How does the GMP certificate relate to the MA, and when is it renewed?
For products manufactured abroad, the site’s TİTCK GMP certificate is valid for 3 years from the inspection date and can be extended by 3 years at a time through a risk-based inspection application, filed no earlier than 6 months before expiry. Since loss of validity of documents submitted in the application is a ground for suspending the MA, certificate dates should be tracked together with the MA calendar.
What happens if renewals or updates are late?
Under Article 22 of the Regulation, failure to update the SmPC/PIL and loss of validity of documents submitted in the application are grounds for suspending the MA. If the ground for suspension is not disproved within six months, the MA is cancelled and manufacture or import of the product stops.
Answers are based on the Regulation on the Marketing Authorisation of Human Medicinal Products (consolidated, 30.12.2025), the TİTCK Marketing Authorisation Department FAQ (16.02.2024) and TİTCK’s Guideline on Applications for GMP Inspections of Foreign Manufacturing Sites (İDD-KLVZ-21, Rev. 10, 22.09.2025), and are for general information. Current legislation and TİTCK announcements prevail.
