It is intended to guide on the information required by the Saudi Food and Drug Authority for: Labeling information Summary of Product Characteristics (SPC) Patient Information Leaflet (PIL)
General Requirements
Applicants should maintain the integrity of each section of the document by only including information relevant to the section heading (SPC and PIL). SPC, PIL and labeling contents cannot be changed without authority approval. Applicants are required to submit SPC, PIL and labeling documents in searchable, readable PDF format that is clean from stamps, watermarks, signatures, headers or footers.
Requirements for Labeling
A separate text for outer and inner packaging labeling should be completed per strength and pharmaceutical form. Arabic translation is required for some labeling components.
Particulars to appear on the outer packaging and the immediate packaging
Name of the medicinal product Statement of active substance(s) List of excipients Pharmaceutical form and contents Method and route(s) of administration Special warning: keep out of reach of children Other special warnings, if necessary Manufacturing and Expiry dates Special storage conditions Special precautions for disposal Manufacturer name Name and address of the marketing authorisation holder Batch number General classification for supply Datamatrix – refer to drug barcoding Global Trade Item Number (GTIN) Serial number
Minimum particulars to appear on blisters or strips
Name of the medicinal product Name of the marketing authorization holder Manufacturing and Expiry dates Batch number Other (e.g., calendar days, etc.)
Minimum particulars to appear on small immediate packaging units
Name of the medicinal product and route(s) of administration Method of administration Manufacturing and Expiry dates Batch number Contents by weight, by volume or unit Special storage conditions Other (correct space) Datamatrix Global Trade Item Number (GTIN) Serial number (SN)
Requirements for SPC
Name of the medicinal product Qualitative and quantitative composition Pharmaceutical form Clinical particulars (therapeutic indications, posology, contraindications, warnings, interactions, pregnancy/lactation, driving, undesirable effects, overdose) Pharmacological properties (pharmacodynamics, pharmacokinetics, preclinical data) Pharmaceutical particulars (excipients, incompatibilities, shelf life, storage, packaging, disposal) Marketing authorisation holder Date of first Authorisation/renewal Date of revision of text Dosimetry (for radiopharmaceuticals) Instructions for preparation of radiopharmaceuticals National Pharmacovigilance Centre (NPC): Call Center 19999 / npc.drug@sfda.gov.sa / https://ade.sfda.gov.sa/
Requirements for PIL
What (invented name) is and what it is used for Before you take or use the product How to take or use the product Possible side effects How to store the product Further information
