National Knowledge Base (UBB) Registration
His full name is T.C. This system, which is the National Information Bank of Pharmaceuticals and Medical Devices (TITUBB), is a web-based registration platform organized by the General Directorate of Pharmaceuticals. In this system, the companies engaged in production, sales, import and export are kept under certain CE regulations. These regulations are:
1. 93/42 / EEC Medical Devices (Medical Device Directive).
2. 98/79 / EC In Vitro Diagnostic Medical Devices (In vitro) Medical Diagnostic Devices Regulation.
3. 90/385 / EEC Active Implantable Medical Devices.
The National Knowledge Base system was restructured as of January 1, 2014. With the new arrangement, registration is done online via the system.
Who Should Make the National Knowledge Base Registration?
All companies that manufacture or import drugs or medical devices within the framework of these directives must register with the National Knowledge Base. During the registration process, both the company and the product imported and imported must be registered. In addition to the manufacturer companies, companies that carry out drug or device distribution works must register the company. The companies that need to register products are manufacturer and importer companies.
What is the Purpose of the National Knowledge Base?
The main purpose of the system is to ensure that all processes related to any drug or medical device such as quotations, sales, procurement, transportation, delivery, inventory, invoicing are carried out in an electronic environment. At this point, all persons and institutions that are in charge or responsible can perform their transactions through the National Knowledge Base.
The National Knowledge Base ensures the use of common data on related drugs and devices. By using the same data in all parts of the supply chain, the work of all parties will become faster and easier. This approach, also known as Master Data Alignment, creates a common database for information such as sales price, classification, shipping conditions, etc. of a medicinal product.
The National Knowledge Base is a quality e - health system prepared in accordance with world standards. Companies registered in the system will also gain various benefits directly or indirectly by using such a platform. The system benefits all parties operating in the process between seller and buyer.
What are the Documents Required for Registration in the National Knowledge Base?
We can divide the documents required for registration into two as product registration and company registration. Documents required for company registration are as follows:
1. Notarized company signature circular.
2. Notary approved chamber of commerce activity registration / registration form.
3. Photocopy of the Trade Registry Gazette.
4. Company registration form.
We can list the documents requested for product registration as follows:
1. CE certification: Along with Aslı, notarized copy, consular certified copy or TÜRKAK certified copy are required.
2. Declaration of conformity.
3. Turkish user manual.
4. Product label information and label sample (must be prepared on CD).
5. Certificate of authorization.
6. Product catalog.
Companies that have not registered with the National Knowledge Base
The companies that carry out at least one of the activities covered by the system and realize the necessary registration process, obtain great advantages. Firms that are not integrated into my site may experience major problems in some cases because they do not provide the necessary accreditation. Not being recognized by local and global authorities in the pharmaceutical and medical device industry is one of them and the largest.
Pharmacies are among the companies that fall within the scope of the system. With the announcement made by the Ministry of Health of the Republic of Turkey, Turkish Pharmaceuticals and Medical Devices National Information Bank (TİTUBB) about Pharmacies to Register the Company, it is stated that the registration of the pharmacies will be transferred from the Pharmaceutical Tracking System (İTS) to the TİTUBB system.
National Knowledge Base Consultancy Service
Making a UBB registration without any problems, preparing the necessary documents and providing documentation requires a certain knowledge and experience. Companies who want to register and use the system efficiently can get support from consulting firms in this regard. Many consultancy companies support UBB in the process of registering companies and products, necessary correspondence in this regard, and providing fast and effective solutions to the problems that may arise. Thus, companies start using the system in a very short time and avoid unnecessary waste of time.