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Scientific Office Requirements by SFDA

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Regulatory Editor

According to the Saudi pharmaceutical law and regulations, every marketing authorization holder (MAH) with a registered drug manufacturer in Saudi must establish a scientific office (TSO). This establishment must be licensed by the Saudi Food and Drug Authority (SFDA), does not need to be a legal entity, and is not a must-have before product registration. However, it is required after the drug approval to provide the market with safety, technical, and marketing information.

This post will outline the types of scientific offices that companies can establish, their role, and what SFDA expects.

Definition

The scientific office is the pharmaceutical establishment that provides scientific, technical and marketing information for pharmaceutical and herbal preparations in the Kingdom. It must have an SFDA license and can have a commercial record issued by the Ministry of Investment (Legal Entity).

According to Article 6 in the Saudi Law of Pharmaceuticals and Herbal Establishment, Every company or institution that manufactures pharmaceutical or herbal preparations – which has a registered factory in the Kingdom – must have a scientific office. To grant a scientific office license, the following are required:

  • Its director must be a full-time Saudi pharmacist licensed to practice the profession.
  • It must meet the conditions and specifications specified by the regulations.

License Requirements

Issuing the SFDA license for the scientific office is a fast process because the license is almost instant once a few documents are provided. This is because the SFDA performs the compliance check during the inspection which will be scheduled at a later stage. The scientific office requirements are:

  • Fill out the Scientific Office application
  • Attach the Scientific Office Manager National ID
  • Attach the Scientific Office Manager SCFHS license (Pharmacist practice license)
  • Payment of SFDA fees.

Responsibilities

All non-commercial activities are the responsibility of the scientific office, including compliance with regulatory requirements, pharmacovigilance, drug promotion, stock reporting, shortage of drugs, labelling updates, meeting and lectures approval, medical representatives’ licenses, support continuity of education, training of colleague pharmacist, etc. You may refer to the inspection points below for more details. Here is a list of the responsibilities:

  • Availability of a valid SFDA license for the scientific office.
  • The technical director is a full-time Saudi pharmacist licensed to practice the profession.
  • Availability of a valid license (SCFHS) to practice the profession for every practitioner employee.
  • The office occupies an independent building or part of the company building and has the necessary equipment and references to perform the assigned tasks.
  • The office fulfils all requirements and circulars specified by the Authority and publishes them on its website. E.g. Saudi drug information and stock reporting (SDI)
  • Provide accurate information about the company’s registered and traded products.
  • Ensure the accuracy of the information used in marketing the company’s products.
  • Responsible for compliance with the Saudi Code of Ethics in Marketing Pharmaceuticals.
  • Implementing the pharma regulations and guidelines issued by SFDA.
  • Supports the scientific activities related to the company’s products.
  • Contribute to the scientific studies and research.
  • Trains the company’s employees and students of the Pharmacy College to become familiar with the tasks of the scientific office.
  • Supervise and ensure active drug registration.
  • Contributes to spreading health awareness and drug education.
  • Provide free samples of registered products, with the phrase “Free Sample” clearly printed on them, and store them in accordance with technical standards.
  • Monitor the company’s products after they are registered and marketed, and inform the Authority of any observations related to the quality and effectiveness of the preparations.
  • Reporting side effects (ICSRs) or medication errors after marketing according to the periods specified in the regulations.
  • Support health sector workers to attend health conferences.
  • Ensure prompt update of the product labels and safety information such as the leaflet (PIL), SPC, and outer packaging of the registered drugs.
  • Ensure the presence of a QPPV and a pharmacovigilance system according to the guidelines for the foundations of good pharmacovigilance practices.
  • Ensures that the Pharmacovigilance Officer is a full-time Saudi pharmacist licensed to practice the profession.
  • Ensures that the medical representatives are Saudi pharmacists licensed to practice the profession.
  • Ensures that all the pharma promotions are according to the SFDA guidelines.
  • Obtaining approvals from the Authority for scientific meetings arranges by the marketing or sales team.
  • Registration in the disclosure and transparency system and ensures on-time reporting.
  • Establishing a quality management system with the availability of the minimum required standard operating procedures (SOPs).
  • Continuity of Supply Reporting
  • Control of Printed Packaging Materials
  • Handling Medical inquiries and requests for Information.
  • Approval of Advertising, Promotional and Educational materials

Inspection

The SFDA performs a periodic inspection of all licensed scientific offices in the market. The inspectors have a long checklist that consists of all the points we mentioned in the responsibilities section. The scientific office manager should be ready to answer all questions related to every point and show the inspector the related documents, trackers, and records.

Penalties

  • Warning.
  • Fine: SAR 100,000.
  • Suspension: closing of the establishment for not more than 60 days.
  • The fine and the suspension penalties can be combined.
  • License Cancellation.

Exceptions

Many pharma companies have been operational in the Saudi market for many years without a scientific office. However, that does not mean they have an official exception from the SFDA. For more information about the current status of SFDA enforcement of scientific office law, please contact us.

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PharmaKnowl provides support for scientific office managers by helping them establish all documentation required, the quality system (SOPs), and how to deal with inspectors professionally to ensure full compliance and avoid penalties.

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