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When people refer to "FDA Law" in Jordan they commonly mean the regulatory framework that governs food, drugs, medical devices, cosmetics, and related products. In Jordan that framework is implemented primarily by the Jordan Food and Drug Administration - a national regulator responsible for product registration, licensing, inspections, quality control, pharmacovigilance, and enforcement. Aqaba, as a major port city and a special economic zone, is subject to national food and drug regulations while also operating under the Aqaba Special Economic Zone Authority - a local authority that can affect customs, licensing procedures, and business permits for companies located in the zone. Regulatory requirements in Jordan are intended to protect public health, ensure product safety and efficacy, and monitor the safety of marketed products.
Food and drug regulation touches many commercial and compliance issues. You may need a lawyer if you are:
- Registering a pharmaceutical, medical device, food product, cosmetic, or supplement and need help preparing and submitting a complete dossier.
- Facing an inspection, warning, administrative fine, product seizure, or recall and require representation during the enforcement process.
- Importing or exporting regulated products through Aqaba and need assistance with customs, permits, and compliance with both national and special economic zone rules.
- Drafting or negotiating distribution, manufacturing, or licensing agreements that involve regulatory responsibilities and liability allocation.
- Establishing local manufacturing or packaging operations and must comply with Good Manufacturing Practice requirements, facility licensing, and environmental or occupational health rules.
- Handling adverse event reports, product liability claims, or disputes about product quality or labelling.
- Seeking administrative remedies or judicial review of regulator decisions such as registration refusals, suspension orders, or contested enforcement actions.
Key legal and regulatory features relevant to food and drug matters in Aqaba include the following elements.
- National regulatory framework - Jordanian statutes and regulations establish requirements for product registration, labeling, safety testing, quality control, manufacturing standards, and pharmacovigilance; these are enforced by the Jordan Food and Drug Administration.
- Licensing and registration - Pharmaceuticals, medical devices, food products, cosmetics, and certain supplements must often be registered or licensed before they may be marketed. Registration dossiers typically include technical data, safety and efficacy information, manufacturing details, certificates such as GMP and free sale certificates, and labeling samples.
- Inspections and compliance - Regulators conduct inspections of manufacturing sites, warehouses, pharmacies and importers. Findings can lead to corrective actions, fines, product holds, recalls or suspension of licenses.
- Labeling and advertising - Label content and advertising of regulated products are controlled to ensure truthful claims and appropriate language requirements. Some categories require Arabic labeling or specific disclosure elements; advertising of pharmaceuticals is usually restricted.
- Customs and imports - Importers must comply with import permits, customs classification, testing at ports of entry, and clearance procedures. Aqaba s status as a special economic zone can change certain customs and procedural requirements while not removing public health obligations.
- Product recalls and market surveillance - Authorities maintain the power to order recalls, market withdrawals or seizures when product safety or compliance is at issue. Companies are expected to have processes for traceability and corrective actions.
- Criminal and administrative penalties - Serious violations can result in administrative fines, suspension of business licenses, and in some cases criminal prosecution for conduct that endangers public health.
- Local business regulation - If operating inside the Aqaba Special Economic Zone, additional permits and approvals from the Aqaba Special Economic Zone Authority may be required for business activities, building use, or storage of regulated goods.
The primary national regulator is the Jordan Food and Drug Administration. It sets registration, licensing, inspection and enforcement policies for pharmaceuticals, medical devices, food, cosmetics and related products. In Aqaba you will also interact with the Aqaba Special Economic Zone Authority for local permissions and customs procedures.
Most pharmaceuticals, many medical devices, some food products, and cosmetics require registration or notification prior to marketing. Requirements vary by product category and by whether the product is manufactured locally or imported. Always confirm classification and registration requirements before placing a product on the market.
Aqaba has special economic policies that may affect customs duties, import procedures, and business licenses. However, public health and safety regulations remain applicable. Businesses in the zone must comply with national food and drug rules as well as any zone-specific administrative requirements from the local authority.
Typical documents include a product dossier with composition and formulation details, manufacturing process description, certificates of analysis, GMP certificate for the manufacturer, free sale certificate or equivalent, stability data for pharmaceuticals, labeling samples, and safety or efficacy information for therapeutic products. Exact requirements depend on the product class.
Document the inspection, cooperate while protecting legal rights, and obtain a written report of findings. If violations are alleged, seek legal counsel experienced in regulatory matters to assess the findings, prepare corrective action plans, negotiate with the regulator, and represent you in administrative proceedings if necessary.
Noncompliance can lead to administrative penalties, product seizures, forced recalls, suspension or revocation of licenses, loss of market access, reputational harm, and in severe cases criminal charges. Timely compliance and documented corrective actions reduce these risks.
Yes. Pharmaceutical advertising is tightly controlled and often limited to healthcare professionals. Food and cosmetic labeling must meet specific content and language requirements. Claims on labels need to be substantiated and not misleading. Check category-specific rules for precise obligations.
Processing times vary depending on the product type, completeness of the dossier, and regulatory workload. Simple notifications can be completed faster while complex pharmaceutical registrations or device approvals may take months. Engaging counsel or regulatory consultants can help prepare a complete dossier to avoid delays.
Yes. Foreign manufacturers often appoint a local authorized representative or importer who bears regulatory responsibilities, including communication with authorities, handling import permits, and post-market obligations. The representative s responsibilities should be clearly defined in a written agreement.
Look for lawyers or law firms with experience in health regulation, regulatory compliance, administrative law and commercial transactions. Verify experience with the national regulator and any work inside the Aqaba Special Economic Zone. Ask about previous matters handled, language capabilities, fee structure and whether the firm works with regulatory consultants or technical experts.
Helpful governmental bodies and organizations to consult for regulatory information and procedural guidance include the national regulator responsible for food and drug oversight, the Aqaba Special Economic Zone Authority for local permits and customs matters, the Ministry of Health for public health policy, the national customs authority for import and clearance rules, and standards-setting bodies for product and lab testing requirements. Trade associations, local chambers of commerce and professional associations such as the national bar association can also assist with referrals to lawyers and with understanding commercial requirements. Laboratories and qualified regulatory consultants may be needed for testing, stability studies and dossier preparation.
If you need legal assistance with food and drug matters in Aqaba follow these practical steps:
- Identify your immediate regulatory need - registration, import, response to an inspection, contract drafting, or dispute resolution.
- Gather core documents - product specifications, manufacturing certificates, correspondence with regulators, import records, and any inspection reports or administrative notices.
- Search for counsel with demonstrated experience in food and drug regulation and in handling matters before the national regulator and the Aqaba Special Economic Zone Authority. Ask for references and examples of prior work.
- Schedule an initial consultation to discuss the facts, potential risks, timing and estimated costs. Prepare a concise list of questions and provide the lawyer with relevant documents ahead of the meeting.
- Agree on engagement terms in writing - scope of work, fees, retainer and communication expectations. Confirm whether the lawyer will coordinate with technical experts when needed.
- Act promptly on regulatory deadlines. Timely filings, corrective actions and transparent communication with regulators typically produce better outcomes than delay.
- If you are unsure about next steps or face emergency enforcement action consider urgent legal representation to protect rights and preserve options for administrative review or negotiation.
