Examination of the License File

The application file of the product for which a license application will be applied is examined, and whether it is suitable for the application and its deficiencies are determined. Technical support is provided to the license holder in the provision of missing information and documents.

Preparation of the License File in CTD Format

All modules of the registration application files in CTD format for prescription, non-prescription and traditional herbal medicinal products are prepared in accordance with current regulations. The file is prepared in accordance with the features requested by the institution in the electronic application, the e-application process is carried out by creating an Xml file.

Preparation of Variation Files

The application type (Type IA, Type IB or Type II) of the relevant amendment is prepared in accordance with the current guidelines and an e-application is made.

SmPC/PIL Transactions (SmPC/PIL)

In line with TITCK announcements, circulars and current regulations, Brief Product Information (SPC) and Instructions for Use (PIP) files are prepared. The e-application is made by making translations in line with the original product SPC and/or PIL data.

Readability Test

Regarding medicinal products for human use, “Packaging Information, Instructions for Use and Follow-up Regulation of Medicinal Products for Human Use” published in the Official Gazette dated April 25, 2017 and numbered 30048 and “Packaging Information and Instructions for Use of Medicinal Products for Human Use” dated 23.02.2018. & In accordance with the Guide on the Package Information of Medicinal Products for Human Use and the Legibility of the Instructions for Use & Guidelines on the Package Information of Medicinal Products for Human Use and Excipients in the Instructions for Use”, it is obligatory to perform the Readability Test for the Instructions for Use of all products whose license will be issued. In this context; It is sufficient to submit the test protocol during the license application, and it is obligatory to submit the test report before the license issuance.

As Tusem Consulting, we support partners in the Readability Test. Our Readability Testing services; protocol writing, writing the questions with their justifications, applying the test, and preparing the report. Companies can request each service separately or together in line with their needs.

2.4. Non-Clinical and 2.5. Clinical Report Summaries

Literature review and reporting for 2.4 Non-Clinical General Summary and 2.5 Clinical reports are carried out by specialist doctors and pharmacists (pharmacologist, technologist or toxicologist). The relevant reports are prepared in accordance with the legislation and delivered to the company together with the signed 1.4.2 and 1.4.3 documents.

License Renewal

As of the license issuance date, for once only, deficiencies are determined for the licensed products that have completed and/or are about to expire, application files and expert reports are prepared.

License Transfer

The license file to be taken over is examined, the requirements and deficiencies are determined, and the application file is prepared in accordance with the legislation. Upon request, price applications and sales permit applications are also made following the transfer of the license.

GMP Application File

In line with current guidelines, domestic and/or international GMP application files are prepared and audits are accompanied.

Analysis Operations

In line with the current guidelines, the required sample numbers, standards and necessary documents are determined, the application file is prepared, and an electronic application is made upon request.

Price Transactions

Applications for price, price increase and price decrease are made for the license.

Preparation of Inner-Outer Packaging

It is prepared by experts and competent designers in inner and outer packaging designs in line with current regulations and guidelines.

Preparation of BY/BE Files

BY/BE Turkish summary reports, in-vivo BY/BE and in-vitro study reports are prepared in the format requested by the institution and in line with current legislation and guidelines.

Technical and Medical Translation

Necessary technical and medical documents in the license file are translated in accordance with the terminology.

Institution Tracking Transactions

All kinds of applications are made electronically for our requesting companies, the documents that need to be delivered physically are sent to the institution, the applications are followed up, and the information and paperwork flow between the company and the institution is ensured.