Mozambique Pharmaceutical Licensing

Decree No. 16/2023, the Regulation on Pharmaceutical Activities, applies to pharmaceutical activities carried out by natural or legal persons in the public and private sectors, and expressly covers manufacturing, wholesale and retail premises. First, break down the project according to its actual activities: retail sales to the public, domestic/cross-border wholesale distribution, storage and transportation, manufacturing, and product marketing or controlled-drug matters. Do not infer that all permissions have been obtained solely from a company name or a single industry registration.

National-level pharmaceutical licensing and inspections are carried out through the ANARME system. Municipal or other local authorities may issue documents concerning permits for the use of manufacturing premises or proof of distance/population for proposed pharmacy sites. However, this research found no basis for treating local attestations as substitutes for ANARME operating licences, nor did it verify a system under which provinces separately issue nationwide pharmacy, wholesale or manufacturing licences.

The Regulation requires foreign applicants to submit proof of residence for applicable applications. However, the available official materials are insufficient to extend this requirement into a fixed foreign ownership percentage, company form, minimum registered capital or equity restriction. For any investment, franchise or merger and acquisition structure, first obtain written confirmation from ANARME on the licensed entity and the entity to which documents will be issued.

— Retail: obtain an alvará for the premises through the pharmacy/sales outlet pathway.

— Wholesale, import, export, storage, distribution and transportation: obtain an alvará through the enterprise and premises pathway and comply with the applicable good practices.

— Manufacturing: obtain a manufacturing licence and GMP certification, and separately obtain an AIM for each product intended for commercialisation.

— Individual professional registration, product AIMs, per-shipment import/export documents and controlled-drug certificates are not automatically included in an enterprise operating licence.

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ANARME, IP is the principal competent authority for the three business categories addressed in this guide. Its public licensing information lists licences for manufacturing, import, export, distribution and retail entities, as well as pharmaceutical professionals. It also states that manufacturing is subject to GMP inspections, while importers, wholesalers and pharmacies are inspected for compliance with good distribution and dispensing practices. Market surveillance may cover pharmaceutical premises, general commercial premises, informal markets, product entry points and healthcare facilities.

The current regulatory framework is based on Decree No. 16/2023, the Regulation on Pharmaceutical Activities, which repealed the previous 2009 regulation. Manufacturing GMP is supplemented by Decree No. 29/2019; enterprise licensing for import/distribution/storage/export/transportation is supplemented by Decree No. 22/2023; and the relevant good practices are supplemented by Decree No. 23/2023. Resolution No. 18/2025 separately confirms the legal licensing regime for retail premises.

Marketing authorisation for medicines (AIM) is handled by ANARME’s Department for the Evaluation of Medicines, Biological Products and Health Products. This department works with the inspection and licensing department, but an AIM remains a market decision concerning a product’s quality, safety, efficacy or performance; it is not an alvará for premises.

— ANARME inspection and entity licensing: premises, professionals, inspections and market enforcement.

— ANARME Department for the Evaluation of Medicines: AIMs, special use and emergency use for medicines, vaccines, biological products and related products.

— Minister responsible for health: named as the recipient in certain prescribed application formats; applicants should confirm the submission method against ANARME’s current intake requirements and forms.

Pharmacies and medicine sales outlets may operate only after ANARME issues an alvará. The Regulation on Pharmaceutical Activities, Decree No. 16/2023, classifies pharmacies by services into Grades A, B and C: Grade A may dispense medicines and preparations, provide pharmaceutical services and conduct prescribed tests; Grade B may dispense finished medicines only and conduct prescribed tests; Grade C may dispense finished medicines only. Retail projects should first select the intended service grade to avoid conducting activities at a Grade C premises that are not covered by that grade.

The published application checklist for opening a pharmacy includes the proposed technical manager’s CV and qualification certificate, an undertaking of good conduct, name reservation or company incorporation documents, proof of residence for foreign applicants where applicable, evidence of distances from nearby pharmacies/healthcare facilities and population, applicant identification, a floor plan showing functional areas, a good pharmacy practices manual and, for Grade A pharmacies, a compounding manual and reference formulae. After installation, the premises must undergo an inspection; an alvará is issued only if the installation meets the requirements.

After authorisation to install is granted, projects in newly constructed buildings generally have two years to complete installation and apply for inspection; projects in existing buildings generally have one year. The Regulation allows one extension of one year, requested at least three months before expiry. These are time limits for the installation stage, not ANARME’s promised processing time or a uniform validity period for a pharmacy alvará.

— Define the intended pharmacy grade and whether preparations will be compounded.

— Arrange the technical manager, local site documentation, company/name details and premises layout.

— Submit the application to open, complete installation in accordance with ANARME’s instructions and apply for inspection.

— Operate only after obtaining the alvará for the specific pharmacy, and maintain good pharmacy practices, prescription and stock records.

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Wholesale premises, importers, exporters, storage/distribution enterprises and transportation enterprises are subject to ANARME licensing. Decree No. 16/2023 provides that wholesale premises may not sell directly to the public; a project intending to engage in retail cannot use a wholesale enterprise licence as a substitute for a pharmacy licence. Decree No. 22/2023 specifically approves the licensing and operating rules for these human medicinal product enterprises, while Decree No. 23/2023 sets out good practices for their import, export, distribution, storage and transportation.

The published wholesale licensing checklist includes a notarised application, company name registration or incorporation documents, the articles of association, NUIT tax number, identity documents and criminal record certificates for the applicant and technical manager, the technical manager’s academic qualifications/good-conduct declaration/professional practice book, premises plans and description, proof of address, and proof of payment of the service fee. Importers additionally require a letter of representation from the manufacturer or laboratory and an import licence issued by the authority responsible for industry and trade. Confirm the document version based on the products, sources and transport model actually intended.

The wholesale technical manager must be a pharmacist with at least two years’ experience in the pharmaceutical field. Distribution premises should procure from qualified local manufacturers or importers. Transport vehicles must meet the products’ technical specifications and have temperature and humidity monitoring; both own-account transport and transport by licensed carriers should be managed in accordance with good distribution practices.

— Specify whether the enterprise will engage in domestic wholesale, import, export, storage, distribution, transportation or a combination of these activities.

— Match the company, tax, premises, technical manager, manufacturer representation and transport documents item by item against the application checklist.

— First obtain the premises/enterprise alvará, then address AIM, import/export and controlled-drug matters as required by the products and shipments.

— Wholesale entities may not sell directly to the public; entities or premises requiring retail sales must follow a separate retail licensing pathway.

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ANARME issues manufacturing licences for manufacturing premises. Application documents include the applicant’s identity documents and criminal record certificate, the technical manager’s academic qualifications and professional practice book, a declaration of the technical manager’s responsibility, premises plans and description, an industrial licence, an environmental licence and a municipal permit for use of the premises. ANARME issues the manufacturing licence only after an inspection confirms that the technical and operational conditions are satisfactory. A manufacturing licence is valid for five years; renewal must be requested six months before the current licence expires.

In addition to the premises licence, GMP certification is based on actual compliance with good manufacturing practices. An application for GMP certification must include proof of payment, the latest applicable factory installation manual and a description of the quality management system. Certification is issued by manufacturing premises and production line and is valid for two years. If an inspection makes recommendations relevant to the issuance of the certificate, the enterprise generally has 120 days to respond; failure to respond on time may result in refusal of the application.

After obtaining a premises licence and GMP certification, the medicines intended for production and commercialisation must still have the relevant AIM. New product manufacture, production of trial batches, and contract manufacturing or changes to manufacturing sites after approval all involve notification to ANARME or a product authorisation variation pathway. A factory licence must not be described as automatically registering a product.

— Complete the preparatory work for industrial, environmental and municipal use permits, as well as premises engineering documents.

— Submit the manufacturing licence application and undergo a technical and operational inspection of the premises.

— Apply for GMP certification using the quality system and factory documentation, and address inspection findings.

— Separately progress product AIMs, trial batch notifications and changes to manufacturing sites or contract manufacturing.

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A company alvará does not confer an individual professional practice qualification. Retail applications require the proposed technical manager’s CV, pharmacist or pharmacy technician qualification certificate, declaration of good standing and professional practice booklet details. A pharmacy must have a pharmacist or pharmacy technician responsible for good pharmacy practice. Their name, category and ANARME registration number must be prominently displayed for the public inside the pharmacy.

A wholesale technical manager must be a pharmacist with at least two years of experience in the pharmaceutical field. Manufacturing premises require the technical manager to perform their duties in person and on an ongoing basis, and at least one additional qualified person to be responsible for the analytical control laboratory. In principle, a manufacturing technical manager must specialise in industrial pharmacy or a similar field; the regulation also provides that, where this specialisation is lacking, a person with specified qualifications and at least five years of relevant experience may serve in that role.

ANARME’s website also lists the application documents for initial issuance and updates to entries in an individual professional practice booklet. Before applying for a company licence, separately verify that the proposed personnel’s registration, practice booklet, qualifications and work arrangements are valid. This research did not verify the complete current rules on recognition of foreign qualifications, examinations, individual practice fees or renewal of individual licences.

— First verify the technical manager’s individual qualifications, ANARME professional practice booklet and practical availability to perform the role.

— Include the declaration of responsibility, appointment/employment arrangements and any applicable working-hours documents in the company application package.

— For manufacturing projects, also appoint a quality-control laboratory manager and an alternate to cover absences.

— When personnel change, obtain/submit the new manager’s documents through the applicable ANARME procedure first; an internal company appointment does not replace regulatory processing.

The floor plan for a retail pharmacy must show the legally required functional areas. The regulation lists a public reception area, storage area, technical manager’s office, toilet with changing facilities, and, where applicable, a quarantine area, dining area and compounding laboratory. Inspections are required both before installation and before the alvará is issued. If an inspection identifies deficiencies, 15 days to three months may be allowed for corrective action, after which a further inspection may be requested.

Wholesale, import, export, storage and distribution premises must be suitable for the intended products, prevent external environmental contamination, have appropriate storage and preservation equipment, and maintain hygiene, lighting, ventilation and suitable air conditioning. Their layout must cover at least reception/display, administrative and technical manager’s offices, checking/order preparation, storage, sanitary facilities, a dining area and, where applicable, utility areas; warehouse areas are restricted-access areas.

Wholesale premises must be equipped with thermohygrometers, shelving, cold rooms where applicable, air conditioning and fire extinguishers. Thermohygrometers and cold-room equipment must be calibrated, with a calibration plan in place. The regulations specify a ratio of warehouse area to floor area, but this is not a general minimum-area requirement for all pharmacies and factories nationwide. Manufacturing premises and different product risks should be assessed against on-site inspection and specific GMP requirements.

— Retail: align functional areas with the service level, good pharmacy practice and inspection requirements.

— Wholesale: design the premises around product risks, temperature and humidity, restricted access, goods receipt/order preparation and storage zoning.

— Transport: use vehicles or qualified carriers that meet product specifications, allow temperature and humidity monitoring, can be cleaned and maintained, and support traceability.

— Manufacturing: in addition to GMP-compliant layout, retain industrial, environmental and municipal use permits.

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All three pathways should follow the basic project-management sequence of application, document review, premises installation or preparation, inspection and issuance. A manufacturing application must consolidate the application, applicant information, technical manager’s documents, premises construction documents, industrial/environmental/municipal permits and proof of fee payment. The manufacturing licence is issued after the ANARME inspection report confirms that the technical operating conditions are satisfactory.

Wholesale and other businesses should submit, according to their actual activities, company registration/articles of association, NUIT, applicant and technical manager identification and police-clearance records, technical manager’s professional documents, premises plans and proof of address. Importers must additionally provide the manufacturer’s letter of representation and the import permit from the authority responsible for industry and trade. Pharmacy applications must include the technical manager’s documents, name/company information, applicable local distance and population evidence, premises plan and good pharmacy practice documents.

ANARME’s published checklists also require certified copies of various documents, notarised signatures, and note that other necessary documents may be requested. Before submission, the project team should confirm with ANARME the current forms, electronic and hard-copy formats, fee payment channels, original/certified-copy requirements, and applicable submission pathway for each combination of business activities.

— Create a list of activities and products, and determine the combination of retail/wholesale/manufacturing and import/export activities.

— Create separate files for the company, personnel, premises, quality system, products and cross-border documents.

— Check the location, layout and required local evidence before committing to construction or a lease.

— Complete a self-inspection before the inspection and retain evidence of payments, submission, requests for additional documents, inspection and corrective actions.

ANARME’s regulatory directory lists Ministerial Order No. 15/2023 as updating the agency’s service fees and repealing the previous fee instrument. Application documents also require proof of payment of the relevant service fee. However, this research has not quoted amounts from the scanned fee schedule that were not verified item by item. For each licence, product AIM, variation, inspection and cross-border application, consult the applicable ANARME schedule on the submission date.

Clearly specified statutory periods must be distinguished: a manufacturing licence is valid for five years, with renewal to be applied for six months before expiry; a manufacturing GMP certificate is valid for two years; good-practice certification for wholesale and similar premises is valid for two years and is renewable; and the deadlines for completing installation and inspection after approval of a retail installation are specified separately for new and existing buildings. A product AIM is valid for up to five years, and medicine renewal must be requested 180 days before expiry.

Apart from the 21 working days for communication stated on ANARME’s page after a pre-submission has been accepted for AIM, and the specific response period for recommendations from manufacturing GMP inspections, this research found no uniform statutory completion time, expedited procedure or fixed fee covering all retail, wholesale and manufacturing applications. Accordingly, no commitment is made regarding approval days, fast-track approval or fixed quotations.

— Before submission, check each fee against ANARME’s current fee schedule and the specific application form.

— Record the expiry dates of manufacturing licences, GMP certificates, company good-practice certifications and product AIMs separately.

— Use statutory renewal lead times as reverse-scheduled milestones; do not confuse them with government processing time.

— Confirm fees and timelines separately for on-site inspections, variations, controlled drugs or emergency imports.

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After initial issuance, pharmaceutical businesses must continue to maintain a technical manager, premises, scope of activities and records consistent with the licence. Wholesale and similar premises must retain import and distribution documents, including inspection/release records, records of expired/recalled/returned products, receipts, invoices, delivery notes and inventory; ANARME may request other relevant documents. Pharmacies must also maintain a general prescription register; prescriptions for specially controlled medicines must be recorded in a dedicated register and filed.

Wholesale, import and retail activities are subject to good distribution and dispensing practice inspections, which may cover quality management, facilities, equipment, operations and self-inspections. In addition to maintaining the manufacturing licence, manufacturers must maintain a GMP quality system; non-compliance with good practices may affect the GMP certificate, and unsatisfactory inspections require corrective action as prescribed.

Renewal of a pharmacy alvará requires a formal application, fee payment, technical manager’s documents and an inspection. If non-compliance attributable to the applicant or owner is identified during operations, ANARME may propose revocation of the pharmacy alvará. If deficiencies are not remedied, the pharmacy may also have its alvará revoked and be closed.

— Retain records relating to supply, batches, inventory, expiry, returns, recalls, sales/dispatch and temperature and humidity.

— Maintain GMP, distribution, dispensing and pharmacy quality systems, and arrange self-inspections and corrective actions following inspections.

— Monitor whether technical managers, branches, vehicles, storage facilities and the scope of the licence remain consistent with the approved documents.

— Apply for renewal of each certificate separately; do not renew just one document and continue all business activities.

Transactions involving a company or pharmacy, relocation and handover to a new manager should not be treated as automatically continuing a licence. A wholesale premises alvará may be issued only to the owner intending to conduct that activity and becomes invalid upon any transfer. A transfer of wholesale premises requires prior authorisation from ANARME; after the transaction, both parties must submit the notarised transfer instrument and the technical manager’s declaration of good standing within 30 days.

A pharmacy alvará is also issued only to the owner of that pharmacy or point of sale and becomes invalid upon any transfer. The owner must submit a transfer application to ANARME in advance; within 30 days after the transaction, both parties must jointly report it and attach notarised documents and the technical manager’s declaration. Dissolution, merger or transformation of a company owning a pharmacy, or a transfer of its shares/quotas, must also be reported to ANARME within 30 days. The relevant legal transaction does not take effect until ANARME issues the corresponding alvará.

ANARME’s public guidance page also lists application documents separately for relocation of pharmacies/businesses, pharmacy name changes, transfers and registration by transcription after an owner’s death. A proposed relocation should be supported by a floor plan for the new premises, an explanation, the existing alvará and applicable local evidence; the alvará for the original premises should not be used to continue operations at the new location.

— Before signing a transaction: confirm the licence holder, ownership structure, premises and technical manager.

— For a transfer or material change in ownership: include prior ANARME authorisation and the subsequent 30-day reporting requirement in the closing conditions and timeline.

— For relocation or a name change: prepare documents under the specific variation application; do not carry the original premises alvará directly over to the new location.

— When replacing the technical manager: also verify the individual’s qualifications, declaration of responsibility and documents to be submitted to ANARME.

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An AIM is ANARME’s decision granting a product the right to be commercialised and distributed after assessment of its quality, safety, efficacy or performance. It may be obtained through registration, notification, special import or emergency import. Its scope includes human medicines, vaccines, herbal medicines and homeopathic medicines; health products have their own applicable registration/notification pathways. An establishment alvará cannot replace an AIM, and a manufacturing licence does not automatically qualify a product for marketing.

Pre-submission for a standard AIM is used to reserve a name, calculate fees and arrange submission of the dossier; the dossier is then submitted in CTD format. An AIM is valid for up to 5 years, and medicines should be renewed 180 days before expiry. The AIM holder remains responsible for maintaining quality, safety and efficacy throughout the product’s entire market lifecycle. Changes to AIM terms, such as the product’s manufacturing site or technical documentation, require a specific variation procedure.

Import and export activities are a separate compliance layer beyond the establishment alvará. For imports involving narcotic and psychotropic drugs, ANARME expressly requires a special application and issues the corresponding certificate. Application documents include a letter physically delivered to the authority, a completed special import authorisation form signed by the technical director and notarised, a BIEF and a pro forma invoice. Distribution of these products should also be managed using a controlled-drug movement chart and signed by the technical director.

— First verify the AIM status, holder and validity period of every product proposed for sale or manufacture.

— Keep separate records for product AIMs, the establishment alvará, manufacturing GMP, cross-border shipments and individual professional qualifications.

— Handle ordinary imports/exports under the current documents issued by ANARME and other competent authorities; do not skip product or shipment requirements on the basis of holding an establishment alvará.

— For narcotic drugs, psychotropic drugs or other controlled products, initiate the specific certificate, prescription/inventory/movement records and regulatory confirmation.

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