Senegal Pharmaceutical Licensing

Decree No. 2023-2421 regulates establishments nationwide, including industrial pharmaceutical establishments, wholesale distribution establishments (depositaries, import/export wholesale distributors and full-line wholesalers) and pharmacies. Company formation, ordinary commercial registration or general trading eligibility cannot replace pharmaceutical-establishment authorisation.

Ownership is regulated separately by establishment category: industrial establishments may be owned by the State, pharmacists or legal entities; wholesale establishments and pharmacies are subject to more specific rules. The materials reviewed do not support a general conclusion on foreign investment eligibility; the proposed structure should be checked with ARP.

ARP implements national pharmaceutical regulations. Municipal-level ordinary business, construction, fire safety, environmental and local health permits were not verified for this review; national pharmaceutical authorisation cannot be taken to cover all local requirements.

— Retail: pharmacy establishment, registration of the declaration of operation, and the obligations of holders and individual pharmacists.

— Wholesale: establishment authorisation, good distribution practices and, where required, transaction-specific import/export authorisation.

— Manufacturing: site-specific authorisation, quality systems/good practices and product-level marketing authorisation (AMM).

ARP implements national pharmaceutical regulations; its website lists functions including product approvals and serialisation, pharmaceutical inspections/market surveillance/pharmacovigilance, quality control and legal affairs.

The principal legal instruments are Law No. 2023-06 and Decree No. 2023-2421. The former governs products, imports and exports, inspections and pharmacovigilance; the latter governs establishments. The Minister makes statutory decisions concerning establishments, while the pharmacists’ association handles professional registration and gives opinions on establishment applications.

— ARP: technical review, inspections, product approvals, market surveillance and databases.

— Minister responsible for health: makes statutory decisions authorising establishments by order.

— Pharmacists’ association: pharmacist registration, professional discipline and opinions on establishment applications.

Establishment, acquisition or relocation of a pharmacy must first be authorised by order of the Minister responsible for health. Before opening to the public, the holder must also obtain registration of a declaration of operation. An application for registration must be submitted within six months after notification of the establishment order; this period may be extended once. If the pharmacy has not opened by the deadline, the establishment order is cancelled.

The national benchmark is one pharmacy per 5,000 people in the same municipality, subject to exceptions on public health grounds. The decree also restricts the planning of a new pharmacy within 800 metres of a pharmacy whose declaration of operation was registered less than three years earlier; the specific distances for new establishments or relocations are set by ministerial order.

The premises must form a continuous whole, must not have direct access to premises used for another profession, business or residence, and must restrict public access to medicines that may only be sold by pharmacists. The operating authorisation for a retail pharmacy is valid for ten years.

— Submit an application form for establishment of a pharmacy, then await the statutory review and authorisation.

— After establishment authorisation is granted, register the declaration of operation and complete pre-opening site preparations.

— Conduct retail operations at the pharmacy actually registered, under the actual holder, with a duly registered pharmacist physically present.

The decree defines full-line wholesalers, depositaries and import/export wholesale distributors separately; the scope of procurement, storage, distribution and import/export must correspond to the authorised category.

Full-line wholesalers must hold at least 80% of the medicines registered in the country and establish a recall plan. Depositaries and import/export distributors must have suitable premises, equipment and personnel, comply with GDP, verify suppliers and customers, and maintain traceability records available for inspection.

Products imported for the local market must be registered in advance and have an AMM or prior authorisation from the regulatory authority; this product-level requirement does not make wholesale operating authorisation an import authorisation.

— Clearly identify the actual category applied for: full-line wholesaler, depositary or import/export distributor.

— Put in place storage, transport, traceability, qualified supplier/customer verification and emergency recall systems.

— For medicines imported for the local market, verify registration, AMM or prior authorisation from the regulatory authority.

An industrial establishment’s operating authorisation must specify the pharmaceutical dosage forms or nature of the products; where there is more than one manufacturing or storage site, each site must be authorised separately. The establishment application dossier must describe the proposed site, operating arrangements, and the identity, competence and qualifications of the responsible pharmacist.

Manufacturers must have a quality control laboratory, a documentation system covering specifications/formulae/procedures and records, a complaint investigation system and a rapid recall system. Records for each batch must be retained for at least five years after the expiry date of the relevant batch.

ARP may inspect manufacturing premises. Industrial establishments must comply with good practices; a certificate of full compliance with good practices is valid for three years.

— Provide separate authorisation and technical management for each manufacturing or storage site.

— Establish systems for quality control, batch release, document retention, complaints, traceability and recalls.

— Maintain GMP compliance throughout operations and renew in accordance with the certificate cycle.

An individual pharmacist’s professional practice authorisation is separate from authorisation of the premises. The responsible pharmacist must hold a pharmacy degree, be duly registered and be responsible for the overall manufacturing or distribution operation. The responsible/deputy pharmacist must be authorised by the pharmaceutical regulatory authority, registered with the association and registered with only one establishment. A registered pharmacist must also be physically present when a pharmacy is open.

The decree generally specifies five years’ practical experience for a responsible pharmacist and three years for a deputy pharmacist. For full-line wholesalers, depositaries and import/export distributors, it also specifies at least one year of practical experience in a relevant establishment, pharmacy or hospital pharmacy. The publicly available materials do not explain how these two sets of requirements apply together; they should not be interpreted by assuming the lower threshold applies. Written confirmation should be obtained from ARP.

If the responsible pharmacist leaves permanently, a successor must be appointed immediately and the appointment documents submitted to the regulatory authority; the pharmacist’s duties include manufacturing, supply, pharmacovigilance, transport, storage, integrity and safety.

— First complete the individual pharmacist’s registration with the association and obtain any applicable professional authorisation.

— Confirm the responsible, deputy, temporary and assistant pharmacist staffing requirements for the establishment type.

— Update records with ARP/the pharmaceutical regulatory authority upon appointment, replacement or cessation of duties.

Establishment authorisation takes into account installation conditions, equipment quality and personnel qualifications. All establishments must ensure hygiene, safety and environmental protection and comply with good practices; good-practice certificates for industrial and wholesale distribution establishments are valid for three years and five years, respectively.

Wholesale premises should minimise errors and ensure proper storage; industrial premises must have a quality control laboratory and systems for documentation, batch release and recalls; pharmacies are additionally subject to requirements for continuous premises, no direct access and display restrictions.

Relocation of a manufacturing or storage site to a location not listed in the operating authorisation requires a separate application for authorisation; it cannot be treated as an automatically effective internal change.

— Prepare suitable premises and equipment, cleaning and maintenance arrangements, and quality/distribution controls for the actual activities.

— Match retail, wholesale and manufacturing activities to their respective premises requirements and inspections.

— Before moving a site, adding a manufacturing/storage location or making a major alteration, confirm the authorisation pathway with ARP.

The process comprises authorisation for establishment/acquisition/relocation and operating authorisation. A committee within ARP reviews the dossier; the association gives its opinion within forty-five days of receipt, and the regulatory authority processes industrial and wholesale dossiers within ninety days. Neither timeframe constitutes a promise of approval or project delivery.

ARP publishes forms for pharmacy establishment, operating registration, relocation, transfer and renewal, as well as forms for establishment and operation of manufacturing/wholesale businesses, responsible pharmacists, amendments and renewals. The complete dossier requirements are determined by ministerial order and decision of the ARP Director General.

Before applying, settle the establishment category, site, ownership information, responsible pharmacist and product scope, and confirm the attachments against the current ARP forms; the general webpage does not show a complete, current attachment checklist applicable to all categories.

— Determine the business category, site, activities for which authorisation is sought, ownership/control information and responsible pharmacist.

— Submit the establishment application using the current ARP forms and respond to the association’s opinion, requests for supplementary information and inspections.

— After receiving the establishment decision, submit the operating application or register the pharmacy’s declaration of operation within the statutory period.

Swipe horizontally to view all items

The ARP authorisation, inspection and forms pages reviewed do not provide a uniform fee schedule that can safely be applied to pharmacies, all wholesale categories and industrial establishments; before submission, confirm the fees, paying entity, invoice and payment method with ARP for the relevant category.

The decree expressly specifies good-practice certificate validity periods of three years and five years for industrial and wholesale establishments, respectively; industrial and wholesale establishment or relocation authorisations are valid for five years from the signing of the operating authorisation; pharmacy operating authorisations are valid for ten years. Continuing operations remain subject to renewal, inspections and mechanisms for suspension/revocation.

— Fees: as specified in the current ARP case-specific notice or formal fee decision.

— Timeframes: the association’s forty-five-day opinion period and the ninety-day processing period for industrial/wholesale dossiers are not guarantees of expedited processing or approval.

— Validity periods: set reminders based on the separate validity periods for establishment authorisations, good-practice certificates and individual authorisations.

Ongoing compliance centres on good practices, inspections, pharmacovigilance, quality, and security of supply. Institutions must maintain applicable good-practice standards and certificates; industrial and wholesale institutions must also maintain safety stock equivalent to at least three months’ consumption and establish a pharmacovigilance system.

Manufacturing institutions must retain batch records and operate complaint-handling and rapid-recall procedures. All wholesale distributors, consignees, and import/export distributors must have arrangements to promptly withdraw defective or suspect products.

ARP pharmacist inspectors may inspect pharmacies, manufacturing, distribution, and storage. Failure to correct non-compliance by the deadline may result in a warning, suspension of supply, seizure/quarantine, suspension or withdrawal of an AMM, or suspension or revocation of the institution’s authorisation.

— Maintain GMP/GDP, three months’ safety stock, and quality-incident and pharmacovigilance arrangements.

— Keep inspection-ready records of batches, the supply chain, complaints, withdrawals, and appointment changes.

— Address issues identified during inspections in accordance with formal corrective-action requirements and deadlines.

Any extension, change, or amendment to an initial establishment/operating authorisation must be notified to the pharmaceutical regulatory authority and is subject to verification. Relocation of a manufacturing or storage site to a location outside an authorised site requires separate authorisation.

Establishment, acquisition, and relocation each require authorisation by the Minister after consultation with the relevant professional association; they do not automatically transfer to a new entity as a result of a sale and purchase agreement, share transfer, or change of directors. ARP also has separate forms for changes to manufacturing/wholesale operations, pharmacy relocation, and information on pharmacy transfers.

A pharmacy may be relocated only within the same municipality or between municipalities in the same region, subject to conditions including supply and length of operation. Changes to pharmacy partners and shareholdings must be documented in writing, with copies submitted to the association and regulatory authority.

— Before a transaction, determine whether it concerns the legal entity/shareholding, responsible pharmacist, site, scope, or product.

— Complete the relevant authorisation procedures in advance for establishment, acquisition, relocation, and relocation outside the authorised site.

— Retain ownership agreements and proof of submissions to the association/ARP; do not treat corporate completion as a substitute for a pharmaceutical regulatory decision.

An AMM is separate from an enterprise operating authorisation. Law No. 2023-06 divides approval into registration, renewal, and amendment; registration results in an AMM. Before a medicine may be supplied in Senegal, it must have an AMM granted by ministerial order. A special public-health authorisation must not be treated as a standard AMM.

Only manufacturing institutions, wholesale distribution institutions, and specially authorised healthcare institutions may import or export medicines, and each import/export operation requires authorisation from the regulatory authority. The regulatory authority may prohibit imports of products without an AMM or where the risk is disproportionate; the reason for exporting a product without an AMM must be stated.

Controlled products such as narcotic drugs, psychotropic substances, and chemical precursors are also subject to specific regulations. The manufacture, import, distribution, and dispensing of narcotic drugs require dedicated receipt and issue registers, which must be retained for at least 10 years. A general operating authorisation does not replace this authorisation.

— For each product, verify its AMM, holder, dosage form, and applicable amendment status.

— Obtain separate authorisation from ARP/the pharmaceutical regulatory authority for each import/export consignment, and ensure it corresponds to an authorised institution category.

— Handle controlled medicines separately under the specific authorisation, storage, record-keeping, prescription, and reporting rules.