Jordan Pharmaceutical Licensing

This entry discusses only retail sales through public pharmacies, wholesale through pharmaceutical warehouses, and pharmaceutical manufacturing of human medicines in Jordan; it does not discuss financial licensing. The law classifies factories, pharmaceutical warehouses, public/private pharmacies, pharmaceutical research and development companies, and pharmaceutical laboratories as pharmaceutical establishments. No establishment may be established or owned on the basis of general commercial registration alone.

The national basic rules are governed by the Drug and Pharmacy Law and the Ministry of Health and JFDA framework; verification of planning/lease documents by the Greater Amman Municipality or the relevant municipal authority may also be required for the actual address. The law reviewed expressly allows a pharmaceutical factory to be established/owned by a natural or legal person; however, public pharmacies and warehouses have specific ownership/purchase rules designed around pharmacist status. The materials reviewed do not establish a generally applicable foreign shareholding percentage or company form; obtain written confirmation before investing, based on the business, shareholders, and location.

— Retail: rules on establishing/purchasing a public pharmacy, the person in charge, and premises.

— Wholesale: pharmaceutical warehouse licensing, agency imports, GSDP, and distribution rules.

— Manufacturing: factory licensing, on-site GMP authorisation, and technical management responsibilities.

— Products, cross-border trade, and controlled drugs: each is a separate matter for assessment.

The Minister of Health holds statutory authority to decide pharmaceutical-establishment licensing matters. The Pharmacists Association Council has a recommendation or opinion role in matters including establishment, ownership, purchase, and cancellation. The 2019 Pharmaceutical Establishments Licensing Regulation principally elaborates the application, premises, and inspection requirements for public/private pharmacies, pharmaceutical warehouses, pharmaceutical laboratories, and research and development companies, and expressly does not apply to pharmaceutical factories.

JFDA is an important authority for medicine registration and circulation, GMP/GSDP inspections, and related regulatory decisions. Its published communication matrix lists factory licensing and GMP authorisation separately, and likewise separates the MoH licensing steps for wholesalers/pharmaceutical warehouses from JFDA’s GSDP review. Accordingly, a letter from either authority should not be mistaken for authorisation of all pharmaceutical activities.

— MoH/Minister of Health: statutory decision chain for pharmaceutical-establishment licensing, relocation, transfer of ownership, or cancellation.

— JFDA: medicine registration, product-circulation decisions, GMP/GSDP inspections, and regulatory conclusions.

— Pharmacists Association: legally required recommendations and opinions, and interfaces relating to pharmacists’ professional registration.

A public pharmacy is a pharmaceutical establishment that directly prepares and dispenses medicines to the public and supplies infant formula, among other things, within the statutory scope. Establishment or purchase is not ordinary retail-shop registration: the applicant must follow the statutory pharmacist-related pathway, and the Minister of Health decides on the basis of a recommendation from the Association Council. A private pharmacy is attached to a hospital, government health centre, or qualifying charitable institution and cannot simply be treated as governed by the public-pharmacy rules.

The operating responsibilities of a public pharmacy are inseparable from its on-site personnel. The law provides that the pharmacy’s pharmacists are generally responsible for technical and financial management. A pharmacist may be designated to assume technical management after notification to the Ministry of Health, JFDA, and the Association; where the conditions are met, financial responsibility may be delegated. The pharmacy must also provide medicines-use counselling to users as required by law.

— Before establishing/purchasing, verify the applicant pharmacist’s individual practice qualifications, years of practice, existing establishments, and undertaking to serve as the person in charge.

— A retail pharmacy must not conflate its establishment licence with product registration, prescription, or controlled-substance requirements for medicines it sells.

— The person in charge of the pharmacy must procure from authorised suppliers and must not handle expired, damaged, or smuggled medicines.

A pharmaceutical warehouse is an establishment for importing, purchasing, storing, selling, and distributing medicines to pharmacies and other entities authorised to sell medicines. Establishment or ownership of a warehouse requires the Minister’s authorisation and the Association’s recommendation. In principle, a new warehouse or a purchased warehouse must be operated by a full-time pharmacist; more than one pharmacist may jointly own a warehouse. The law also generally provides that a pharmacist may not own more than one warehouse or own both a warehouse and a public pharmacy, subject to special arrangements for pre-existing cases when the law came into force.

Medicine imports must be conducted through a warehouse acting as agent for the pharmaceutical company. An importing warehouse may grant distribution rights to another warehouse, but the importing warehouse’s responsible pharmacist remains responsible for the medicines and must notify JFDA of the distribution contract and products. Distribution rights for the same medicine may not be granted to multiple warehouses in the same governorate. Warehouse sales must use the registered original packaging; repacking or dispensing smaller quantities requires JFDA approval.

— First obtain MoH establishment authorisation, then cooperate with the GSDP inspection arranged by JFDA, CAPA corrective actions, and the regulatory decision.

— Incorporate warehousing, receipt, dispatch, supplier/customer qualification, temperature control, and batch traceability into the quality system.

— Importing a registered product from a non-recognised manufacturing site requires separate approval from the JFDA Director General under the statutory procedure.

A pharmaceutical factory is an establishment that manufactures medicines, preparations, fills products, or manufactures active ingredients on an industrial scale for wholesale. A factory may not obtain a pharmaceutical factory licence solely for packaging or repackaging. Every pharmaceutical factory must obtain the Minister’s authorisation before establishment or commencement of operations. Although a natural or legal person may establish/own a factory under the law, the factory must still comply with applicable technical, health, personnel, administrative-responsibility, and other current regulatory requirements.

A pharmaceutical factory may not begin manufacturing on the basis of the Minister’s authorisation alone. The law requires an inspection before operations commence to confirm implementation of current pharmaceutical GMP principles recognised by the JFDA Director General. JFDA’s published process further indicates that a manufacturing-facility application first undergoes completeness and fee confirmation, followed by an on-site inspection; the subsequent steps are a licensing decision, GMP site authorisation, status registration, publication, and follow-up.

— The full-time technical manager pharmacist and the full-time batch-release pharmacist should be separately identified in the organisation chart, duty statements, and notification records.

— Match each production line, dosage form, testing, release, outsourced activity, and site to the proposed application scope and GMP evidence.

— Distribution of locally manufactured medicines must be through a pharmaceutical warehouse established in accordance with the law, or a factory distribution centre approved by the JFDA Director General.

An individual practice licence and authorisation for a business/site are two different matters. The law places pharmacy practice (including manufacture, import, storage, distribution, sale, preparation, and dispensing) within the professional scope of licensed pharmacists. Recognition of a pharmacist’s qualifications, registration with the Association and Ministry of Health, and practice requirements must be checked individually according to the person’s nationality and qualification route. Employment by a company, holding an overseas licence, or serving as a director does not establish Jordanian practice eligibility.

Each pharmaceutical establishment must have one or more pharmacists responsible on a full-time basis. During temporary absence, a licensed pharmacist must be appointed in writing as a substitute and the relevant authorities notified; one pharmacist may not be responsible for multiple pharmaceutical establishments at the same time. Factories additionally require a full-time technical manager pharmacist and a batch-release pharmacist; warehouses and public pharmacies are also subject to their own ownership and responsible-person rules.

— Individual: verify the degree, professional registration, practice licence, and any applicable requirements for foreign pharmacists/reciprocity.

— Retail/warehouse: prepare evidence of full-time status, appointment, substitute cover, and changes to the person in charge.

— Manufacturing: prepare the division of responsibilities between the technical manager and batch-release roles, as well as staff lists and change notifications.

A public pharmacy must have a single entrance (except for a Civil Defence-approved emergency exit), no connecting door to a clinic, warehouse, or residence, a net floor area of at least 30 square metres, and a distance of at least 200 metres, measured between the nearest points, from an existing licensed public pharmacy. It must also have a reception area, laboratory, and sanitary facilities; it should have no windows other than a small window for the sanitary facilities. Building-front setback restrictions and exceptions must be handled in accordance with permanent approval documents from the Greater Amman Municipality or the relevant municipality.

A pharmaceutical warehouse must have a net area of at least 85 square metres and at least one administrative office and one storage warehouse, a reception area, and sanitary/service facilities; it must not open directly into a clinic, pharmacy, or residence. The express numerical requirements for public pharmacies and warehouses are not factory standards. A pharmaceutical factory site must pass the applicable GMP inspection; specific premises, equipment, and sanitary/technical requirements should be confirmed against JFDA manufacturing licensing materials and on-site inspection.

— Retail: verify distance measurements, area, floor plan, entrances, and planning documents before signing a lease or starting fit-out.

— Warehouse: separate administrative areas from medicine storage areas, and design controls for receipt, quarantine, storage, and dispatch.

— Manufacturing: Conduct a GMP site gap assessment based on the process, production lines and quality system, rather than applying pharmacy/warehouse figures.

Applications for public pharmacies and pharmaceutical warehouses may be submitted by a pharmacist to the competent licensing department in paper or electronic form. The basic documents listed in the 2019 Regulation include: proof of full-time employment (evidence of leaving the previous workplace and social security documentation), approval by the Association’s Board, a pharmacist’s professional licence, proof of identity, valid occupancy/lease documents certified by the Greater Amman Municipality or the relevant municipality, a recent title deed when the premises are leased, a site and coordinates report issued by a licensed surveyor, planning approval, commercial registration/signatory-authority documents, proof of trade name, an institutional seal in Arabic, and an undertaking to comply with technical and sanitary equipment requirements.

Once the documents are complete, the Pharmaceutical Institutions Inspection Committee formed by the Minister must inspect the proposed premises within two weeks and submit its recommendation to the competent official; the Minister then decides whether to grant the licence. The two-week period is the regulatory deadline for the site inspection after completion of the documents, not a commitment for the entire approval process. Factory applications follow JFDA procedures for manufacturing facility licensing, site inspection and GMP authorisation. The published matrix refers to an annex to the Instructions for Licensing Pharmaceutical Manufacturing, but the full text of that annex was not obtained for this review.

— First define the application category: a public pharmacy, pharmaceutical warehouse, factory licence, GMP/GSDP, product registration and import procedures cannot be combined into a single application.

— Pharmacy/warehouse: complete the sequence of document-completeness review, site inspection, Association recommendation and Ministerial decision.

— Manufacturing: prepare the application dossier, supporting documents, site inspection and GMP authorisation materials for the manufacturing site/production line.

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The Ministry of Health licensing fees stated in the 2019 Regulation are: JOD 400 for a public pharmacy, JOD 2,000 for a private pharmacy and JOD 1,000 for a pharmaceutical warehouse; when relocation of a pharmaceutical institution is approved, half of the corresponding fee above is charged. Pharmaceutical laboratories and research and development companies also have separate fees, but they are not among the three core business categories covered by this record. The Regulation does not specify factory fees, so pharmacy/warehouse fees must not be applied to a manufacturing project.

As to timing, the prescribed milestone for inspecting proposed pharmacy/warehouse premises is within two weeks after the documents are complete; the Association has 30 days to provide an opinion when legally required to do so, and failure to respond within that period is deemed consent on the matter of the Association’s opinion. The JFDA matrix also lists working-day milestones for inspection reports, decisions or follow-up on deficiencies. These are individual procedural milestones and do not constitute a uniform commitment for complete approval, product registration or commencement of operations. No general licence validity period or uniform renewal cycle applicable to all three types of institution was identified in this review.

— Public pharmacy: JOD 400 (Ministry of Health licensing fee specified in Article 16 of the Regulation).

— Pharmaceutical warehouse: JOD 1,000 (Ministry of Health licensing fee specified in Article 16 of the Regulation).

— Relocation: 50% of the corresponding fee specified above, if approved.

— Pharmaceutical factory: confirm fees, certificate validity and renewal arrangements with JFDA/MoH for the current application scope.

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Licensing conditions must continue to be met after operations begin. Pharmaceuticals must be stored within the institution in accordance with the approved conditions; storage outside the institution requires the Minister’s approval and compliance with the conditions for an approved warehouse, and the responsible pharmacist remains accountable. The pharmacist in charge must purchase from authorised sellers and continuously prevent expired, damaged or smuggled pharmaceuticals from entering the supply chain. Factories, warehouses and pharmacies are also subject to JFDA risk-based periodic/annual GMP, GDP or GSDP inspections and follow-up on remediation of deficiencies.

Circumstances that may legally result in cancellation of a licence include: failure to commence operations within the prescribed period after licensing (five years for a factory, which the Minister may extend by a reasoned decision; this is not the licence validity period), continuous suspension of operations for more than six months without an accepted reason, relocation without approval, failure to comply with ownership conditions, misuse of controlled substances, sale to an unqualified party, concealment of beneficial ownership or obtaining a licence by fraud.

— Maintain a full-time pharmacist in charge, handovers, signatures/seals and the list of persons in charge.

— Maintain GMP/GDP/GSDP quality systems, storage records, traceability, inspection readiness and closed-loop CAPA.

— Include cessation of operations, off-site storage, controlled-substance inventory and compliance anomalies in management escalation procedures.

Ownership transactions and licences are not automatically linked. Purchases of pharmaceutical institutions such as pharmacies/warehouses follow a separate application route: the pharmacist purchasing the institution must first apply; after initial consent is obtained, the required documents, including a notarised sale and purchase agreement, commercial/trade-name documents in the purchaser’s name and a new institutional seal, must be submitted within one month. The competent official may extend this completion period by an equal period; the Minister then makes a decision based on the Association’s recommendation.

For a change to the institution’s name, postal address or pharmacist in charge, the owner must notify the Ministry of Health, JFDA and the Association within ten working days; the departure of a pharmacist in charge must also be reported within ten working days. Relocation requires the Minister’s prior approval, and the new premises must meet the licensing conditions. The regulations also require the Ministry of Health to notify JFDA and the Association of decisions concerning licences, relocation, transfer of ownership or cancellation. When the person responsible for controlled drugs leaves, separate procedures apply for transferring inventory and records and cancelling that person’s individual controlled-substance permit.

— Equity, asset or warehouse/pharmacy purchase: do not assume that the licence transfers automatically; first verify the purchase licensing procedure.

— Name, postal address or pharmacist in charge: complete the statutory notification within ten working days.

— Relocation, off-site storage, cessation of operations or a transaction affecting actual control: assess whether Ministerial/JFDA approval is required before signing and implementation.

Pharmaceutical product registration/marketing authorisation is separate from an institutional licence. Finished medicines must be registered with JFDA and obtain a Director General’s decision permitting their circulation; product registration documents also include a valid, authenticated manufacturing licence. Even if a company holds a pharmacy, warehouse or factory licence, this does not authorise it to sell, import or manufacture products lacking the applicable product authorisation. The five-year registration/renewal period stated in the biological products registration guidelines applies at product level and must not be treated as the term of an operating licence.

For ordinary imports and exports, the law provides that customs may not release the listed products and raw materials without approval from the JFDA Director General or an authorised person. The warehouse for imported medicines must be the agent of the pharmaceutical company; additional approval is also required to import registered products from a manufacturing site that has not been approved. Narcotic drugs and psychotropic substances additionally require relevant individual/institutional controlled-substance permits and import/export permits. The scope of permits differs for pharmacists responsible for warehouses, pharmacists in charge of pharmacies, factory technical managers and designated pharmacists, and requirements also apply to secure packaging, inventory, records and periodic reporting.

— For each SKU: verify product registration/circulation status, approval of the manufacturing site, packaging, batch and storage conditions.

— For each cross-border consignment: verify import/export approval, agent warehouse, customs documents and source manufacturing site.

— For controlled products: separately track permits for persons in charge, import/export certificates, inventory handovers, annual/quarterly reports and secure custody.