Services

License holding services are provided in order to carry out product registration and GMP procedures in Turkey on behalf of foreign companies that are not established in Turkey. In this way, registration procedures can be started before the establishment of the Turkish branch of the company, and time and pre-registration costs can be saved.

Getting prioritization approval before starting the GMP and registration processes ensures that the evaluation and approval processes are brought forward and accelerated.

Especially for the facilities where GMP inspection cannot be performed on-site by Turkish authority due to the pandemic, obtaining high priority approval paves the way for applications to be made on paper based.

For the products that are prioritized for the registration processes, the file evaluation is done before the non-priority products and the registration period is shorter.

Finished product production facilities and biological active substance production facilities located in a country other than Turkey must be inspected and certified by Turkish authority before a registration application in Turkey. The application is prepared and submitted in line with the relevant regulation and guideline, and correspondence and follow-up are carried out until the GMP certificate is received at the end of the process.

For biological, biotechnological, conventional, traditional herbal, vaccine, etc. pharmaceutical products, registration files are prepared and submissions are made in accordance with current legislation requirements. The preparation and application stages can be summarized as follows:

– Examining original documents and identifying deficiencies

– Organizing the translation of the necessary sections

– Preparation of Word documents in a format specific to company

– Creating PDF files with combining reports and certificates

– Preparation and submission of electronic application

– Creating an xml template for uploading and adapting the file to the xml template

– Uploading the CTD file via authority kiosk

– Conducting correspondence with the authority during the registration process

For a product in the registration phase, an analysis application has to be made and the results of the analysis have to be found appropriate. Otherwise, the registration certificate will not be issued.

Analysis applications are prepared in line with current legislation requirements and submitted to the authority with product samples and necessary materials.

For a registered product, it is obligatory to obtain a sales permit before it is place on the market. In addition, after the transfer of the production site from abroad to Turkey or from Turkey to abroad, after packaging size change, after the MA transfer process and after unsuspension of the suspended products, a sales permit must be obtained before the products are place on the market.

An application is prepared and submitted to the authority in line with current legislation requirements.

In these applications, physical samples were previously required to be submitted, but with the last updated regulation, it is no longer required to submit physical samples.

MA holder change and price-reimbursement transfers

Applications for MA holder change are prepared and submitted in accordance with current legislation requirements. Correspondence with the authority is carried out until the MA transfer is completed.

After the transfer, sales permit, pricing and reimbursement transfer applications are made and followed up until the approval stage.

Five years after the MA is issued, the authority makes an evaluation regarding the renewal, taking into account the benefit/risk balance. In accordance with the provisions of the relevant regulation, the dossier containing all updated information on efficacy, safety and quality, including the evaluation of suspected adverse reaction reports and periodic benefit/risk evaluation reports, and information on all variations made since the registration of the product, is submitted to the authority nine months before the end of the five-year period.

In line with current legislation requirements, Type IA, IB and II variation applications are prepared and submitted to the authority. The original file contents are examined in accordance with the legislation, the application type and deficiencies are determined, and the company is notified. It is aimed to shorten the evaluation and approval process of the authority by completing the requirements at the beginning, if any. Correspondence with the authority is coordinated until approval is received.

SmPC-PILs for reference and equivalent product are prepared to be submitted in the CTD application or in the variations of related changes. For the preparation, SmPC-PILs of the global reference products and products approved in our country, and legislative requirements are taking into account.

In line with current regulatory requirements, all importers of medicinal products for human use are required to apply for a batch release site permit and a responsible manager.

The documents required for the application are notified to the company, the file is prepared and submitted to the authority.

Within the scope of supplying medicines from abroad through Turkish Pharmacists Association (TEB) or SSI, activities are carried out to add the products to the list of the products to be supplied from abroad.

Preparation of files for obtaining Supplementary Food Permits, obtaining authority permits, realization of import shipments

Reimbursement application files of equivalent products and products after the MA transfer are prepared in accordance with current legislation and the processes in the SSI are followed until the approvals are received.

• Daily document tracking in electronic environment
• Delivery of physical documents to authorities
• Receiving physical documents from the authorities
• Interpreting the authority letters and forwarding them to the company
• Uploading application files via the authority kiosk
• Appointment request processes from the authority
• Participating in appointment meetings with the authority on behalf of the company
• Product sample and material delivery to the laboratory department
• Strategic application planning
• Follow-up of legislative updates