Every company managing a human medicinal product portfolio in Türkiye needs a team to handle marketing authorisation, lifecycle, pricing and reimbursement work. Building that team in-house is not the only option. Under a retainer model, a continuing service agreement whose scope is set according to the portfolio, an external regulatory affairs department can take this work on. The model has three core advantages: cost, scope and expertise.
1. The cost advantage
Building an in-house RA department means staffing for different areas of expertise such as marketing authorisation and pricing/reimbursement, recruiting and training, and managing the team. Personnel costs are fixed, but the workload is not: it multiplies during price change periods, in months when renewals cluster or with a new MA application, and falls in between.
Under a retainer, the cost is set according to your portfolio and expected workload, and is predictable. No extra staff are needed for peak periods. The risk of losing dossier history and process knowledge when people change jobs also falls, because the work is tied to a team and an established calendar rather than to one person.
2. The scope advantage
Marketing authorisation and pricing are not separate worlds. Under the MA Regulation, a sales authorisation is required before a product is placed on the market for the first time, and TİTCK grants it for a product whose price has been approved. After regulatory steps such as an MA transfer or a pack size change, a new sales authorisation is also required before the product is placed on the market.
The pricing calendar is tight as well. Under the transitional provision of the 2026 Pricing Communiqué, products with unchanged prices also had to apply in the 2026 price change period, with limited exceptions. When the same team handles regulatory and pricing work:
- MA, renewal and price application dates for every product are tracked in a single calendar.
- The sales authorisation and pricing consequences of a regulatory change are not missed.
- You have a single point of contact for correspondence and applications with the authorities.
3. The expertise advantage
The rules change fast. The MA Regulation published on 11 December 2021 was amended seven times by the end of 2025. In pricing, 2026 brought a new Presidential Decision (11 March 2026, No. 11031) and an implementing Communiqué (29 August 2026), and the Pricing Guideline was revised on 20 October 2026. The ePIL becomes mandatory on 1 January 2027. TİTCK’s expectations in practice are shaped not only by legislation but also by sources such as its FAQ on marketing authorisation procedures, which alone runs to 95 pages.
It is hard for a small in-house team to follow all of these changes and apply each one across its portfolio. A team working on many companies’ dossiers sees how the same change plays out across different products and application types. That experience feeds directly into applications prepared right the first time and quick responses to TİTCK deficiency letters.
Who is it for?
- Companies that want to manage a portfolio in Türkiye without setting up an RA department
- Companies with a small portfolio that could not use a full-time team efficiently
- Companies that want to support their existing team during peaks such as price change periods and renewal deadlines
Under this model, the MAs and the MAH’s legal responsibilities stay with the company; the external department takes on the preparation and follow-up of the procedures.
From your marketing authorisation and lifecycle work to your pricing and reimbursement procedures, we at Melvin International Consulting would be glad to give you the most professional support at every step. See our Regulatory Affairs Outsourcing service or get in touch.
Sources: Regulation on the Marketing Authorisation of Human Medicinal Products (OG 11.12.2021, consolidated 30.12.2025), Art. 25 and 28; Communiqué on the Pricing of Human Medicinal Products (OG 29.08.2026), Transitional Art. 1; Pricing Guideline (EDİT-KLVZ-11, Rev.2, 20.10.2026); TİTCK FAQ on marketing authorisation procedures (16.02.2024). This article is for general information only; current legislation and TİTCK announcements prevail.
