Pharmaceutical Market Entry in Türkiye

Bringing a human medicinal product to Türkiye takes a marketing authorisation from TİTCK, a TİTCK GMP certificate for manufacturing sites abroad, an approved price, a sales authorisation and, for reimbursed medicines, a place on the SGK reimbursement list. This page is a practical overview for companies based outside Türkiye.

Who can hold a marketing authorisation?

Under Article 6 of the Regulation on the Marketing Authorisation of Human Medicinal Products, marketing authorisation (MA) applications are made by natural persons or trading companies established in Türkiye. A trading company must employ an authorised person who holds a degree in pharmacy, medicine or chemistry and is entitled to practise in Türkiye (Article 7).

A manufacturer without a company in Türkiye therefore needs a Türkiye-based marketing authorisation holder (MAH). The two usual routes are:

• Your own company in Türkiye acting as MAH, keeping the authorisation in your own hands.
• A local partner, such as a licensee or distributor, holding the MA for your product under your agreement with them.

An MA can later be transferred to another company, and the rights arising from a pending application can also be transferred (Articles 26 and 27), for example to your own subsidiary once it is set up.

Melvin does not hold marketing authorisations. We work alongside you and your MAH, whether that is your own company or a partner, as their regulatory affairs team.

If you do not have a marketing authorisation holder yet

Many manufacturers look at Türkiye before deciding who will hold the authorisation. In that case we can:

• compare the two routes (your own company in Türkiye or a local partner) from a regulatory point of view: responsibilities, the authorised person requirement and timelines;
• start the gap analysis and the Turkish Module 1, SmPC and PIL work in parallel, so the dossier is ready when the MAH is in place;
• act as the regulatory affairs department of your new Türkiye-based company (Regulatory Affairs Outsourcing);
• if you start with a partner, plan the later transfer of the authorisation or the pending application to your own company (Articles 26 and 27).

Company formation and commercial agreements are outside our scope; we work alongside your legal advisers.

From application to market: the main steps

1. Dossier and application. The MA application is submitted electronically to TİTCK with a CTD/eCTD dossier, including the Turkish SmPC and PIL. Applications can be made all year round; the authorisation process itself is started only in February, May, August and November, in line with the relevant guideline (Articles 6 and 12).
2. Pre-assessment. TİTCK checks the dossier for completeness within 30 days. Any deficiencies must be completed within 30 days, and the second pre-assessment is also concluded within 30 days (Article 12).
3. Evaluation. Once TİTCK notifies the start of the authorisation period, the process is to be concluded within 210 days. Time taken by external evaluations, official holidays and extraordinary circumstances is not counted (Article 14).
4. GMP inspection. Manufacturing sites abroad need a TİTCK GMP certificate. The inspection application is made by the importer established in Türkiye, and on-site inspections of sites not previously inspected are scheduled according to the priority order set by the Priority Evaluation Board.
5. Price. The price application is made in TİTCK’s İFPAS system with a price declaration document, which must be apostilled or consular-legalised. Applications outside the Committee route are concluded within 45 days at the latest.
6. Sales authorisation. A sales authorisation is required before the product is placed on the market for the first time. TİTCK grants it for a product whose price has been approved, after reviewing the pack sample and the PIL (Article 28).
7. Reimbursement. For the product to be reimbursed, an application is made to the Social Security Institution (SGK) for inclusion on the reimbursement list and is assessed through SGK’s commission procedures.

After launch, the MAH must keep the authorisation current: variations, SmPC and PIL updates, the five-year renewal and, from 1 January 2027, the ePIL (e-KT). See Regulatory Lifecycle Management.

What we will need from you

• The registration dossier in CTD format and the documents for Module 1
• GMP documentation for the manufacturing and batch release sites
• Price declaration documents for the price application
• Your approved SmPC and PIL, for the Turkish versions and the PIL readability (user) test or bridging report

How Melvin supports companies entering Türkiye

• Gap analysis of your dossier against TİTCK requirements and preparation of the Turkish Module 1
• Turkish translation of the SmPC, PIL and labelling (Medical and Regulatory Translation)
• PIL readability testing or bridging (PIL Readability Testing and Bridging)
• The MA application and its follow-up with TİTCK until authorisation (Marketing Authorisation)
• GMP inspection applications for your manufacturing sites (GMP Inspections)
• Price applications and SGK reimbursement (Pharmaceutical Market Access)
• Variations, renewals and the ePIL after launch (Lifecycle Management, ePIL Conversion)
• Working as the regulatory affairs department of your Türkiye-based MAH (Regulatory Affairs Outsourcing)