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المملكة: "Food and medicine" The scientific advice service is launched to direct innovators before licensing the products
The Food and Drug General Authority offered a guide for scientific and organizational advice via the “poll platform" Directed to the applicants, it aims to organize the mechanism of obtaining technical advice on products subject to the jurisdiction of the authority. /> She explained that the provision of scientific and organizational advice is an optional procedure and is not part of the application to obtain a product marketing license, and it does not include the file evaluation, so applicants are advised to refer to relevant guidelines to ensure the type of application and fulfill its requirements."Text-Align: Jusify"> Requirements for advice application
I explained “ Food and medicine " The request for advice must be done through a dedicated model, and it must include a clear description of the product "Name, reasons for use, development stage, and proposed organizational path"And a business schedule that includes the issues to be discussed with the estimation of the time necessary for each point, in addition to the information and supportive documents related to the question submitted. "My presence, default, or written response"And a list of the names of the participants from the applicant, if it was found, and proposing dates for the meeting within eight weeks from the date of submitting the application. The authority also confirmed that it will accept a limited number of requests monthly, according to the availability of resources and capabilities."Text-Align: Jusify"> Formulas for advice
The commission identified three main formulas to advise:
3. Written response "Wr"A written response is sent to the applicant instead of holding a meeting. The application procedures
I explained “ Food and medicine " The request for advice must be done through a dedicated model, and it must include a clear description of the product "Name, reasons for use, development stage, and proposed organizational path"And a business schedule that includes the issues to be discussed with the estimation of the time necessary for each point, in addition to the information and supportive documents related to the question submitted. "My presence, default, or written response"And a list of the names of the participants from the applicant, if it was found, and proposing dates for the meeting within eight weeks from the date of submitting the application. The authority also confirmed that it will accept a limited number of requests monthly, according to the availability of resources and capabilities."Text-Align: Jusify"> Formulas for advice
The commission identified three main formulas to advise:
3. Written response "Wr"A written response is sent to the applicant instead of holding a meeting.
The application procedures The process begins by providing the form and documents via e -mail "It will be determined later". After submission, the authority reviews the application and verifies the scope of the questions, and the applicant shall be notified within 10 working days to accept the application and determine the appropriate type of advice. In the event of problems in the validity of the request, an opportunity is given to amend it within a specific period before cancellation. Extension contract mechanism < /h2> According to the evidence, in the event of a attendance or virtual meeting, the date of the meeting will be agreed within 20 working days from the date of acceptance of the application, and the applicant is required to submit a presentation not exceeding 15 minutes. The applicant is asked to register the meeting minutes and send it in the formula of Word within five working days, while the authority shall respond with observations or approval within ten days. And if the response is written, it is sent within 50 working days from the date of verification of the validity of the request. The legal status of advice
The commission indicated that the advice provided is not legally binding on either party regarding future marketing licensing requests. However, the authority provides advice in good faith, taking into account the possibility of changing conditions or the emergence of scientific developments that may require adopting a different approach from what was previously presented."Text-Align: Jusify"> Fees and discounts
she indicated “Food and Drug”" Until the details The fees will be announced later in the final version approved of the guide, with confirmation that the provision of scientific and organizational advice will be in exchange for a financial return according to the scope of the application "Clinical, pre -clinical, or product quality ". "ATMPS" Or with medication under experience. - For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
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Extension contract mechanism < /h2> According to the evidence, in the event of a attendance or virtual meeting, the date of the meeting will be agreed within 20 working days from the date of acceptance of the application, and the applicant is required to submit a presentation not exceeding 15 minutes. The applicant is asked to register the meeting minutes and send it in the formula of Word within five working days, while the authority shall respond with observations or approval within ten days. And if the response is written, it is sent within 50 working days from the date of verification of the validity of the request. The legal status of advice
The commission indicated that the advice provided is not legally binding on either party regarding future marketing licensing requests. However, the authority provides advice in good faith, taking into account the possibility of changing conditions or the emergence of scientific developments that may require adopting a different approach from what was previously presented."Text-Align: Jusify"> Fees and discounts
she indicated “Food and Drug”" Until the details The fees will be announced later in the final version approved of the guide, with confirmation that the provision of scientific and organizational advice will be in exchange for a financial return according to the scope of the application "Clinical, pre -clinical, or product quality ". "ATMPS" Or with medication under experience. - For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
Follow Us Related Articles
The legal status of advice
The commission indicated that the advice provided is not legally binding on either party regarding future marketing licensing requests. However, the authority provides advice in good faith, taking into account the possibility of changing conditions or the emergence of scientific developments that may require adopting a different approach from what was previously presented."Text-Align: Jusify"> Fees and discounts
she indicated “Food and Drug”" Until the details The fees will be announced later in the final version approved of the guide, with confirmation that the provision of scientific and organizational advice will be in exchange for a financial return according to the scope of the application "Clinical, pre -clinical, or product quality ". "ATMPS" Or with medication under experience. - For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
Follow Us Related Articles
The commission indicated that the advice provided is not legally binding on either party regarding future marketing licensing requests. However, the authority provides advice in good faith, taking into account the possibility of changing conditions or the emergence of scientific developments that may require adopting a different approach from what was previously presented."Text-Align: Jusify"> Fees and discounts
she indicated “Food and Drug”" Until the details The fees will be announced later in the final version approved of the guide, with confirmation that the provision of scientific and organizational advice will be in exchange for a financial return according to the scope of the application "Clinical, pre -clinical, or product quality ". "ATMPS" Or with medication under experience.
- For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
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