Definitions : A “drug product” means a substance or a combination of substances which may be used in or administered to human or animal beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis
Required Services:
- Establishment Licensing System (ELS)
- Warehouse registration
- Drug Establishment National Registry (DENR)
- Saudi Drug Registration (SDR)
- Products Registration
| # | Product Submission Process | Working Days |
| 1 | Generic Products | 165 Working Days |
| 2 | Biological Products | 290 Working Days |
| 3 | Biological Products <New API not registered in KSA> | 415 Working Days |
| 4 | New Drug Registration | 290 Working Days |
| 5 | Radiopharmaceutical | 290 Working Days |
| 6 | Renewal of marketing authorization Holder | 70 Working Days |
| Variation to A marketing Authorization Type IA | 60 Working days | |
| 7 | Variation to A marketing Authorization Type IB | 120 Working days |
| 8 | Variation to A marketing Authorization Type II | 145 Working days |
The validity of the medicinal product registration and warehouse registration is FIVE YEARS.
| # | Product Type | File Submission Fee | SDR Online Application Fee |
| 1 | Generic Products | SAR 40,000.00 | SAR 8,000.00 + KSA VAT |
| 2 | Biological Products | SAR 95,000.00 | SAR 20,000.00 + KSA VAT |
| 3 | Renewal of Generic | SAR 10,000.00 | – |
| 4 | SAR 30,000.00 | ||
| Renewal of Biological | – |