Bringing pharmaceutical products to market in the UAE requires more than just quality manufacturing — it demands strict compliance with local regulatory requirements. One of the essential components in this process is the Product Information File (PIF), a detailed dossier that provides regulators with key information about a product’s composition, safety, efficacy, and more. 

While commonly associated with cosmetics, the PIF is also critical for pharmaceuticals in the UAE and serves as a central document for product registration and regulatory review. 

What is a PIF? 

A Product Information File is a comprehensive document that consolidates all relevant data about a pharmaceutical product. It supports product registration, helps demonstrate regulatory compliance, and plays a key role in post-market surveillance. The UAE’s regulatory authority, the Ministry of Health and Prevention (MOHAP), requires a complete and accurate PIF as part of the pharmaceutical product registration process. 

What is the Importance of PIF in the Pharma Industry? 

The pharmaceutical industry is highly regulated to safeguard public health. The Product Information File is essential because it: 

• Ensures Regulatory Compliance: The PIF is key to demonstrating that the pharmaceutical product complies with UAE laws and international standards. 

• Supports Market Authorization: Without a complete and compliant PIF, MOHAP will not grant product registration or import approval. 

• Protects Public Health: By containing vital safety and efficacy data, the PIF helps regulators ensure that only safe, effective, and high-quality medicines reach consumers. 

• Facilitates Transparency: The PIF provides a structured and centralized source of information that can be reviewed by regulatory inspectors, internal QA teams, and during audits. 

• Aids in Post-Market Surveillance: The file supports pharmacovigilance, enabling quick access to critical product data in case of adverse events or product recalls. 

Roles of a Product Information File 

The PIF is more than just a regulatory formality—it performs multiple functions throughout the product’s lifecycle: 

• Regulatory Role: It acts as the primary document during product registration and renewal with MOHAP and other authorities. 

• Compliance Tool: Serves as evidence that the product and manufacturing processes follow GMP and other applicable regulations. 

• Communication Tool: Facilitates transparency between manufacturers, regulatory bodies, and local distributors. 

• Risk Management: Supports swift responses during product recalls, adverse event investigations, and regulatory queries. 

What does a PIF include? 

The structure and content of a PIF may vary depending on the product type, but generally includes: 

• Product Composition: Include details of all active ingredients and excipients, with specifications and concentrations. 

• Manufacturing Data: Information on GMP-certified manufacturing sites, batch manufacturing records, and quality control protocols. 

• Safety and Efficacy: Clinical data or literature supporting the safety and therapeutic value of the product, toxicological data, and risk assessments. 

• Labeling and Packaging: Product artwork, bilingual labels (Arabic and English), patient information leaflets (PIL), and packaging specifications. 

• Regulatory Certificates: Documents such as the Certificate of Pharmaceutical Product (CPP) and Free Sale Certificate (FSC), especially for imported or OTC products. 

• Compliance Documents: Evidence of pharmacovigilance procedures, recall protocols, and other post-market obligations. 

UAE Regulatory Landscape 

The pharmaceutical sector in the UAE is governed by Federal Law No. 4 of 1983, along with various ministerial decrees and MOHAP circulars. Compliance with MOHAP’s Pharmaceutical Product Registration System is mandatory, and the PIF plays a central role in this process. 

Additionally, regional bodies like the Gulf Central Committee for Drug Registration (GCC-DR) may be involved for products intended for broader distribution in the Gulf Cooperation Council (GCC) region. Regulatory expectations can be dynamic, making up-to-date knowledge of local requirements essential for smooth market entry. 

How OMC Medical Can Support You 

OMC Medical provides tailored regulatory support to simplify the PIF preparation and submission process for companies entering or expanding in the UAE pharma market. 

We can assist you with: 

• End-to-end PIF preparation: From data collection to final submission, ensuring full regulatory compliance. 

• Regulatory liaison: Communicating directly with MOHAP and other authorities to streamline approvals. 

• Compliance assurance: Support with GMP adherence, labeling translation (Arabic/English), and safety documentation. 

• Ongoing regulatory support: Managing PIF updates, renewals, audits, and post-market requirements. 

With OMC Medical as your partner, you can focus on growing your business while we handle the regulatory intricacies. 

Frequently Asked Questions 

Who is responsible for maintaining the PIF in the UAE? 

The responsibility lies with the manufacturer, importer, or an authorized representative established in the UAE. The PIF must be kept available for authorities and updated regularly.  

Does the UAE PIF requirement apply to both prescription and over-the-counter (OTC) medicines? 

Yes, both prescription and OTC pharmaceutical products must have a PIF as part of the registration process with MOHAP. 

Does the PIF need to be updated regularly? 

Yes, the PIF must be updated if there are any changes to the product formula, labelling, manufacturing process, or safety information. 

Is the PIF the same as product registration? 

No. The PIF is a supporting document required during the product registration process. While the PIF provides safety and compliance evidence, registration is the official approval to market the product in the UAE.