The foreign trade license new product application process in the pharmaceutical industry includes obtaining the necessary approvals and licenses for the import or export of new therapeutic products across international borders. This process may vary from country to country, but generally follows these steps:
• Product Registration and Approval: Before applying for a foreign trade license, the pharmaceutical company must first register the new product with the regulatory authority of the importing country. This includes submitting detailed information about the product's composition, manufacturing process, safety, effectiveness and intended use. The regulatory body reviews the application and grants approval if the product meets all required criteria.
• Importer/Exporter Registration: The pharmaceutical company must be registered as an importer and/or exporter with the relevant official authorities in both the exporting and importing countries. This step ensures that the company complies with legal requirements and regulations regarding the import and export of pharmaceuticals.
• Preparation of Documents: Many documents need to be prepared for the process to proceed, including:
• Submission of Application: The company submits its foreign trade license application to the relevant authority in the importing country. The application includes required documents, forms, and fees.
• Review and Evaluation: The regulatory authority in the importing country reviews the application and supporting documents. They evaluate the product's safety, quality and compliance with regulations. This evaluation may include field inspections, laboratory tests, and technical evaluations.
• Approval and Licensing: If the regulatory authority is satisfied with the application and the product meets all requirements, it issues the necessary foreign trade license or import/export permit.
• Customs Clearance: After obtaining a foreign trade license, the company can proceed with customs clearance procedures. The product can be imported or exported in accordance with the approved license.
• Post-market surveillance: Once a new pharmaceutical product is introduced to the market, regulatory authorities may conduct post-market surveillance to ensure continued compliance with safety and quality standards.
It is important to note that the exact process may vary depending on the specific requirements of each country's regulatory authority. Additionally, some countries may have additional steps or special documentation requirements. Therefore, companies involved in foreign trade of pharmaceutical products must work closely with regulatory experts and legal advisors to ensure compliance with all applicable laws and regulations.
With Nacsoft's transfer of this industry-specific complicated process to the eBA platform, NOBEL ILAC has achieved the following basic gains:
1. Monitoring the entire process and its status,
2. Process owners can easily manage the process on the digital platform & increase coordination
3. Digitally archiving all relevant papers and documents into the corporate memory
4. All procedural follow-up of the process by internal and official parties can be easily done in the digital environment.
5. Preventing loss of time, effort and documents with digitalized process management and ensuring process control with traceability in the system.
According to country legislation that protects the consumer, in many countries around the world, the distributor company is responsible for end user demands and technology device replacement in case of irreparable problems. In order to monitor the warranty period of the IT device such as the mobile phone used by the end consumer and to take into account possible damage, change or renewal requests, at least 5 documents such as the seller's invoice of the device, the service form of the authorized service, the device & its original box itself, the change request letter, and photographs of the relevant device are required. Different types of documents should be requested. In this “multi-document” process, digitized with Nacsoft, the device exchange or return process is initiated by archiving all documents and checking the device distribution history, which includes the Seller's PO number - IMEI number and the delivery date and costs on the delivery date.
In the process where automatic cross-checkpoints were included with SAP MM integration, our CSP and eBA platforms combined each relevant document with the relevant claim using OCR technology, and healthy approval processes based on systemic controls were accelerated without checking any manual documents.
Just 3 months after the process was transferred to the digital platform, 8000+ devices and 15,000+ documents were tracked and the decision to replace or return the device was made with only 2 after-sales support personnel and an 80% increase in workforce. In other words, thanks to the solution, 3 man/day's work was completed in 1 hour and 2 FTE was saved. Now, IT distributor, dealer, service manager and customer (device owner) can track and report this process 360 degrees. Currently, all Apple iPhone, Huawei, Asus phones imported and distributed by the distributor are tracked by the system for any repair status.
By transferring the after-sales services - device replacement and return process to the digital platform, BİLKOM has achieved the following basic gains:
1. Monitoring the entire process and its status,
2. Process owners can easily manage the process on the digital platform & increased coordination in the regulatory process
3. Digitally archiving all relevant papers and documents into the corporate memory
4. All procedural follow-up of the process by internal and official parties can be easily done in the digital environment.
5. Preventing loss of time, effort and documents with digitalized process management and ensuring process control with traceability in the system.
All internal and external purchasing processes in different locations of the company were previously done with manual forms and an order could be approved within a few weeks... With the digitalization of the process on CSP; With the integration of SAP into our workflow system, Nacsoft improved the process by using the material serial number for the service process and the SAP product code for the purchasing process, and order forms became evaluated according to quantity and hierarchical level, based on the budget allocated to each department. After automatic checks and approvals, the central purchasing team can receive the request through the system and the tender process is started from the sellers defined as users. The tender is evaluated with the best price offer, and then the optimum price information is sent to the bidders for approval. After the selected quote and its approval by the requester and his senior manager, the process is sent to SAP to create the PO and trigger the goods/service purchasing process. In this way, all request, offer, determination and approval processes before the official PO is created are managed on our workflow platform with all documents and correspondence archives on the corporate digital memory.
e-Invoice solution by Nacsoft enables companies recording all types of paper or digital invoices coming to the company, being able to be followed up by all relevant departments, categorizing invoices on the basis of types, operating all necessary approval processes and setting up warnings for timely payments. It also helps preventing losses due to maturity difference and creating all desired related reports. At the same time, while doing this, e-invoice process enables paper invoices to be archived in digital version with OCR technology.
This process records the customer's billing information via a 'user task'; then automatically emails the invoice. Another task is to check if the invoice is paid on time. 'Invoice sending task' automatically sends the invoice to the customer. The 'incoming payment control task' is implemented by the financial manager. If the customer has not paid the invoice by the due date, it will send an automatic reminder. If the customer does not respond to this reminder, the process is transferred to the financial manager.
Key Achievements
Workflow on CSP helps the company eliminating;
Transportation of cement is a critical process in the industry. Vendor informs the company that transportation will be done by specific truck & transfer information including the license plate number and the name of the driver. Based on each truck's entrance from the gate, confirmation of arrival is done by the gate keeper and after completion of the loading process, the vendor is being confirmed by providing the weight of the material and the cross-checks for related PO/ invoices in parallel to the delivery.
The purpose in this process is to ensure the material that comes exactly with the same amount without any loss on the road. Cement has a high risk to get empty or dry therefore the material loading process is also extremely critical. By running the process on CPS, vendor sees the report of delivery with related truck & date information, the invoices generated from ERP, remaining credit limits , number of OPEN orders, amount of material to be loaded, amount of payments with one click.