Bahrain Pharmaceutical Licensing

This record covers only the entry points for compliance relating to human-medicine retail, wholesale warehouses and manufacturing in Bahrain; it does not cover financial licences. Facility operations, individual pharmacist practice, product market access, import clearance and controlled-medicine authorisation are separate regulatory layers; a company CR or general trading activity does not automatically cover pharmaceutical business.

The process for establishing a new pharmaceutical facility involves coordination among Sijilat, commercial registration, NHRA, civil defence and municipal authorities. The materials reviewed are sufficient to establish the division of responsibilities, but not to safely summarise foreign ownership percentages, company forms or current ownership eligibility for pharmacies or all pharmaceutical facilities. Confirm these matters in writing with NHRA and the commercial authorities before applying or entering into a transaction.

— Retail: establishment, inspection and final approval of a pharmacy/related storage facility.

— Wholesale: registration/licensing of a medicine or raw-material warehouse, GDSP and distribution quality systems.

— Manufacturing: local factory establishment and GMP/laboratory/personnel requirements; products and foreign manufacturing sites require separate licences.

NHRA’s PPR is the principal department for pre-market pharmaceutical authorisation, pharmaceutical facilities and related regulation. Its public guidance requires an application for authorisation before a medicine enters the Bahraini market, with review of quality, safety and efficacy.

Individual pharmaceutical professional licences are processed through NHRA’s healthcare professional system; applications, renewals, transfers and reclassifications are handled through Mehan. Pharmaceutical facilities proceed through Sijilat and NHRA procedures; neither pathway replaces the other. Government service pages also cite the 1997 Decree, the 2015 amendment and the 2019 decision as legal bases for pharmacy/product services.

— NHRA PPR: regulatory point for facilities, pharmaceutical products, imports and manufacturing sites.

— NHRA healthcare professional licensing: individual practice qualifications for pharmacists and other professionals.

— Sijilat, commercial, civil-defence and municipal authorities: registration and premises-approval pathway for new facilities.

NHRA handles the establishment of pharmacies and related storage facilities. Published appendices include passports, certificates of good conduct, engineering plans, leases, application forms and identity documents; approvals and conditions from other competent authorities must also be met. After Sijilat review, payment of the application fee, facility assessment, preliminary approval, fit-out, final inspection and payment, final approval is issued.

The NHRA facility procedure requires the licence to be displayed prominently. The English translation of the publicly available 1997 Decree describes pharmaceutical-centre licences as personal and non-transferable and requires prior approval for significant changes. However, in view of subsequent amendments and the 2019 decision, this record does not treat the specific pharmacy ownership or foreign-investment conditions in that older translation as a complete statement of current requirements.

— First submit an application through Sijilat for the actual address of the proposed pharmacy and related storage facility.

— Prepare personal identity documents, a certificate of good conduct, engineering plans and a lease, and complete the processes of other competent authorities.

— After passing the initial inspection, fit out the premises, then apply for the NHRA final inspection and final approval.

NHRA’s warehouse procedure covers the import, export, distribution, storage or sale of medicines and raw materials. Applicants must meet the eligibility and premises requirements specified in the procedure; the medicines or raw materials handled must be registered or approved by NHRA, and an authorised pharmacist manager is required. Application documents include the layout/location, lease or title deed, identity documents for the owner and partners, the responsible pharmacist’s licence, approvals from other authorities and proof of payment.

A warehouse is not an ordinary commercial space used only to store goods. NHRA requires suitable space, ventilation, protection against contamination/pests, receiving and dispatch areas and segregated areas, air conditioning and temperature monitoring in accordance with GDSP. Cold-chain products also require dedicated equipment, failure-risk management and records. Wholesale distribution should also have a quality system covering receipt, expiry, temperature mapping, transport, training, carriers and audits.

— After the initial inspection, complete construction and fit-out in accordance with GDSP, then apply for the final inspection.

— Verifiable procedures should cover normal storage, cold chain, returns, damaged goods, expired goods, transport and waste disposal.

— Narcotic, controlled or precursor substances should be kept in dedicated secure storage, with continuous records of receipts and issues.

A local pharmaceutical manufacturing company must enter the approval process involving the industrial authority and pharmaceutical control before establishment. The opened English translation of the legislation makes issuance conditional on compliance with WHO pharmaceutical manufacturing requirements and those of other government authorities; refusal and remedies are also addressed under that legislation. Confirm the actual receiving authority, current application forms and inspection requirements through the current NHRA/Sijilat pathway.

The legislation lists production areas, chemical/sterile/microbiological pharmaceutical-control laboratories, and separate storage for raw materials, finished products and hazardous/flammable materials as factory requirements. Manufacturing companies must also maintain records for raw materials and testing, products and testing, and toxic/hazardous substances, and retain samples of each finished-product batch for at least 5 years or until 1 year after expiry, whichever is longer.

— Define the scope of the factory application according to the dosage forms, processes, testing, release and outsourced activities proposed.

— Plan production, quality-control and secure storage areas, and establish systems for batch, testing, deviation and retention-sample records.

— For foreign release/manufacturing sites used for imported medicines, apply separately under international manufacturing-site licensing and product registration requirements.

An individual pharmacist practice licence must be applied for through NHRA’s Mehan system. The NHRA PQR explains that qualifications, relevant practical experience, valid individual registration or a licence from the country of origin/most recent practice, a certificate of good standing and primary-source verification may form part of the assessment. Applicants in pharmacy typically must also pass the Bahrain Pharmacy Licensure Examination; the document specifies exceptions for people from Bahrain or those holding a valid GCC licence.

At the facility level, a warehouse must have an authorised pharmacist manager. At the manufacturing level, the opened English translation of the legislation requires the person in charge of the factory and the production manager to hold licences to practise pharmacy in Bahrain; the pharmaceutical-control laboratory must be supervised by a licensed pharmacist or appropriately licensed laboratory professional. Obtaining an individual licence does not mean that a company, premises or product is approved.

— Individual: address qualifications, experience, certificates, verification and examinations through the PQR and Mehan pathway.

— Warehouse: an authorised pharmacist manager is an explicit requirement.

— Manufacturing: verify the person in charge, production manager and laboratory supervisor positions against the legislation and current NHRA requirements.

To establish a pharmacy, engineering drawings and a lease must be submitted, followed by NHRA assessment, an initial inspection, fit-out and a final inspection. The verified materials do not specify a uniform floor area, distance between premises or fixed fit-out dimensions applicable to all pharmacies; these must not be presented as nationwide standards in Bahrain.

Warehouses should be located away from direct or indirect contamination and have suitable space, lighting, ventilation, cleanable and pest-resistant construction, and designated areas for receiving, dispatch, and segregation of expired/damaged goods. The procedure sets out detailed requirements for air conditioning, thermometer placement, cold rooms/refrigerators, low-temperature equipment, contingency plans for power outages, shelf height, transportation and waste management. Manufacturing plants are subject to additional requirements for production, testing laboratories and segregated storage.

— Retail: Confirm the premises against the drawings, lease and inspection findings; do not treat a building's suitability for commercial use as NHRA approval.

— Wholesale: Base the layout on product storage conditions, temperature control, segregation, traceability and controlled-substance security.

— Manufacturing: Arrange production and ancillary areas according to process, quality control, hazardous materials and retention-sample requirements.

For an ordinary new facility, the applicant submits an application and uploads documents through Sijilat. After assessment by the commercial authority, a non-active CR is issued; NHRA receives the application and conducts its review. Once the fees are paid, an initial inspection is arranged. After outstanding documents are provided and the initial inspection is passed, the applicant completes the fit-out, including equipment/display, and requests a final inspection. Once the final inspection is passed and the fees are paid, the NHRA licence and active CR are issued.

A warehouse application separately specifies the need for an application form, layout and location details, lease/title documents, identification for the owner and partners, the responsible pharmacist's licence, approvals from other authorities and proof of payment. Documents for local manufacturing and product applications should not be mixed into a facility application: a local plant should also confirm the current manufacturing/GMP checklist with NHRA, while product registration is submitted through Adweya as a dossier.

— First determine the applicant entity, actual premises, intended activities and corresponding commercial registration activities.

— Submit facility documents and cooperate with NHRA's initial inspection, requests for additional documents, fit-out, final inspection and fee payment.

— Separately proceed with the pharmacist's Mehan application, product application through Adweya and single-shipment import/controlled-drug procedures.

The government service catalogue publishes fees for some facilities and products. Fees and validity periods for retail pharmacies, importing pharmacies and medicine warehouses are not interchangeable. A uniform current fee/processing period for local manufacturing plants could not be confirmed from the official materials retrievable for this review; refer to the actual NHRA application and latest fee schedule.

The working days published on service pages are online service indicators, not guaranteed timelines for approval of the complete process. In particular, actual receipt and inspection arrangements should be relied on where site selection, inter-authority approvals, requests for additional documents, inspections or GMP remediation are involved. Timelines for international manufacturing sites and medicine product licences are also not the same as those for local manufacturing facilities in Bahrain.

— Retail pharmacy: Initial term 3 years, 900 BD; renewal term 3 years, 600 BD.

— Importing pharmacy: Initial term 3 years, 1,500 BD; renewal term 3 years, 900 BD.

— Medicine/medicinal product warehouse: Initial licence 1 year, 500 BD; renewal 1 year, 300 BD.

— New application for an international manufacturing site: 50 BD; separate product service fees apply to new medicine registrations, renewals and variations.

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Renewal of a facility licence should be applied for at least one month before expiry. NHRA procedures expressly provide that if an application is made within two months after expiry without reasonable cause, the renewal fee is doubled; after two months, NHRA has the right to close the facility. Pharmacies/warehouses should continuously display a valid licence, remain within the approved scope of activities, store medicines properly and not store expired products.

Wholesale warehouses must continuously operate a quality system and maintain controls for temperature management, calibration, cold-chain failure response, transportation, training, audits and traceability. Manufacturing companies should maintain personnel, laboratories, records and retention samples consistent with their approved activities. The product MAH should also manage quality, safety, efficacy and safety information throughout the product lifecycle; these product maintenance obligations do not replace facility renewal.

— Facilities: Start renewal at least one month before expiry and review the status of the CR, licence, responsible person and premises.

— Warehouses: Continuously implement GDSP, temperature mapping, instrument calibration, transport records, segregation and supply-chain quality controls.

— Manufacturing: Continuously manage GMP, batch/testing/retention-sample requirements, key personnel and readiness for regulatory inspections.

NHRA requires facility owners to obtain express approval before making major changes. A pharmacy relocation must be submitted through Sijilat, with the declaration covering the inventory status, including controlled and semi-controlled products, and the method of physical transfer; the old licence must be returned after the final inspection. A pharmacy may not hold two licences at the same time. NHRA approval should also be obtained before a warehouse is sold, rights are relinquished, or its name, address or responsible manager is changed.

A change of ownership does not permit direct transfer while the original CR remains in place. The official procedure requires the original owner to apply to cancel the CR, cease operations for 24 hours, declare the inventory and return the original licence. The new owner then applies for a facility in its own name at the same address. Once the new CR is received, NHRA reviews the application and issues the licence. Changes at product level to the MAH, manufacturing site, packaging, shelf life and storage conditions follow a separate medicine variation service.

— Relocation/major physical change: Apply first, declare the inventory and transfer plan, and use the new premises only after inspection is completed.

— Name, address, responsible manager, sale or disposal of rights: Obtain NHRA approval first.

— Change of ownership: Cancel the original CR/licence and require the new owner to submit a new application; do not represent the licence as automatically transferable.

— Changes to product information: Use the Adweya product variation service, not the facility variation process.

A medicine must obtain an NHRA product licence before it can be sold in Bahrain. The NHRA Medicine Licensing Guideline provides that imports and distribution must be made through an authorised pharmacy/local agent, and that the agreement between the pharmaceutical company and the agent must be submitted to NHRA for review/confirmation. The MAH is responsible for the product's quality, safety and efficacy throughout its lifecycle. Product registration is submitted as a dossier through Adweya and is independent of licences to operate a retail pharmacy, warehouse or local factory.

Imports also require approval through the NHRA DUR system. Attachments published on the government service page include an invoice and, for government hospitals, a purchase order; different fees are listed for registered and unregistered products. Unregistered products may be imported only under the conditions specified in NHRA circulars and with prior authorisation; this is not the usual marketing route. Importers of narcotic/controlled medicines must also apply by specifying the products and quantities, and their release and records are subject to additional controls; exports may also be subject to prohibitions imposed by the competent authority.

— Product: Complete medicine registration first; product renewals and changes to the MAH/manufacturing site/packaging, etc., must also be submitted separately.

— Import: Process each shipment through DUR; confirm the source of supply, registration status, invoice and applicable supporting documents for any exception.

— Unregistered products: First check for the absence of alternatives, foreign registration/CPP, GMP and NHRA authorisation conditions.

— Controlled medicines: In addition to secure storage and registers, apply for each import on a case-by-case basis and comply with release/record requirements.