A marketing authorisation is not a document you obtain once and file away. It is a set of obligations that must be kept current for as long as the product is on the market. The cost of post-authorisation gaps rarely shows up immediately; it tends to surface years later, usually at the worst moment: during an MA transfer, a renewal or a request from TİTCK.
The MAH’s continuing obligations
Article 25 of the Regulation on the Marketing Authorisation of Human Medicinal Products places ongoing responsibilities on the MAH. Chief among them: submitting the changes needed to reflect scientific and technical progress in manufacturing and control methods for TİTCK’s approval, keeping the SmPC and PIL up to date, notifying TİTCK of every change to the product, responding to TİTCK requests on time and keeping the product available on the market. The wider the gap between the approved dossier and actual manufacturing, the greater the risk.
The cost of misclassifying a variation
The Regulation on Variations to Authorised Human Medicinal Products classifies changes by their impact, and each type has its own implementation rule:
- Type IA may be implemented and notified within 12 months. If the notification is rejected, implementation stops at once.
- Type IB is deemed accepted if no negative opinion is received within 30 days of a valid notification, and may be implemented only after that.
- Type II may be implemented only after approval. Assessment takes 60 days, up to 90 days for changes to indications, and the clock stops when further information is requested.
Treating a change with significant impact as a minor variation can mean halted production or supply if it is rejected. Conversely, escalating every uncertain change to Type II wastes time. Grouping variations to the same MA and filing applications on the same subject for different products at the same time are time-saving approaches that TİTCK itself recommends.
Suspension and cancellation: the silent risks
Many of the suspension grounds listed in Article 22 of the Regulation relate directly to post-authorisation management:
| Situation | Consequence |
|---|---|
| Changes to the formula, strength, packaging or SmPC without TİTCK approval | Suspension of the MA |
| Failure to update or notify SmPC and PIL updates | Suspension of the MA |
| No commercial batch placed on the market within 30 months of authorisation | Suspension of the MA |
| A previously marketed product absent from the market for 30 consecutive months | Suspension of the MA |
| Grounds for suspension not refuted within 6 months | Cancellation of the MA |
A product suspended for not being marketed can have its suspension lifted with an undertaking to place it on the market within 18 months at the latest; if the undertaking is not met, the MA is cancelled. Separately, the MAH must notify TİTCK at least 30 days in advance if it cannot supply a marketed product.
Transfers and portfolio deals: settling the past
Post-authorisation housekeeping is tested hardest at MA transfer. An MA that has not been renewed cannot be transferred. According to TİTCK, all variations for the product should be concluded before the transfer. TİTCK assesses the transfer within 30 days, and if the documents it requests are not provided within 30 days, the application is cancelled and the file returned. After the transfer, a sales authorisation must be obtained before the product is placed on the market. Products with the old barcode may be manufactured for one year under a notarised agreement between the parties and placed on the market only by the transferee. A disorganised variation history can directly extend the timeline of a licensing deal or a portfolio sale.
What works in practice
- A single calendar showing renewal, GMP certificate, 30-month rule and pending variations for every product in the portfolio
- Regulatory assessment of every manufacturing and supply change before it is implemented
- Regular checks on SmPC and PIL currency, with the ePIL updated at the same time
From classifying variations to MA transfers, and from SmPC/PIL updates to monitoring suspension risks, we at Melvin International Consulting would be glad to give you the most professional support at every step. See our Regulatory Lifecycle Management service or get in touch.
Sources: Regulation on Variations to Authorised Human Medicinal Products (consolidated), Art. 4, 7, 8, 9, 10 and 16; Regulation on the Marketing Authorisation of Human Medicinal Products (consolidated, 30.12.2025), Art. 22, 23, 25, 26 and 28; TİTCK FAQ on marketing authorisation procedures (16.02.2024). This article is for general information only; current legislation and TİTCK announcements prevail.
