In some recruitment agency procedures, Form Q7B is mentioned as a supplementary annex to the standard domestic labor contract (e.g., for specifying additional working conditions, leave arrangements, or salary details). This is less common and often agency-specific.
Q1: Is Form Q7B mandatory for all drug products in Saudi Arabia?
A: Yes, for all imported and locally manufactured active pharmaceutical ingredients (APIs) and certain high-risk finished products.
Q2: Can a foreign manufacturer submit Form Q7B directly?
A: No, submission must be made through an SFDA-licensed local authorized representative or a Saudi pharmaceutical company holding the product registration.
Q3: How long does verification take?
A: Typically 20–45 business days, depending on completeness of documents and need for additional review. form q7b saudi arabia verified
Q4: What is the difference between Q7B and Q7A?
A: Q7A refers to the ICH guideline; Q7B is the SFDA-specific application form derived from that guideline.
SFDA analysts will verify:
If approved, the GHAD system issues a digitally signed Form Q7B with a unique registration number and expiration date (typically 3 to 5 years). In some recruitment agency procedures, Form Q7B is
A verified Form Q7B typically includes the following sections:
| Section | Description | |---------|-------------| | 1. Site Identification | Name, address, and contact details of the manufacturing site. | | 2. Product Information | API or FPP name, dosage form, strength, and manufacturing process flow. | | 3. GMP Status | Date of last GMP inspection, issuing authority (e.g., EU, US FDA, WHO, or SFDA itself). | | 4. Certification Statement | Declaration that the site complies with ICH Q7 and SFDA GMP regulations. | | 5. Attachments | Site Master File (SMF), GMP certificate, product quality review, and batch analysis data. | | 6. Verification Stamp | Official stamp and signature from SFDA or a recognized authorized body. |
A: Yes, as long as the Q7B is active (not expired) and the product specifications, manufacturer, and importer remain unchanged. Each shipment must reference the same Q7B number in the customs declaration. SFDA analysts will verify:
Submitting an unverified or expired Form Q7B can lead to:
Hence, the phrase "form q7b saudi arabia verified" is not a mere formality—it is a condition for lawful trade.