Portugal Pharmaceutical Licensing

This record covers only retail pharmacy, wholesale and manufacturing of human medicinal products within Portugal. INFARMED is the national competent authority; no state/provincial-level core business licence has been verified. Relocation of a pharmacy requires an opinion from the competent municipal authority, but does not change INFARMED’s licensing role.

Medical devices, veterinary medicines, cosmetics and direct procurement by hospitals follow different pathways. The pharmaceutical legislation sources consulted do not provide a general conclusion on foreign investment, minimum capital or company form; this record makes no assumptions on these matters.

— Author’s statement: prepared by Rengangyongsheng (Hong Kong) Limited and explained by business manager Tang Shangyong (Drew Tang); he is not a pharmacist or a regulatory authority and does not guarantee approval or expedited processing.

INFARMED is responsible for licensing and inspections relating to pharmacies, wholesale, manufacturing and controlled substances, and maintains the relevant technical directors’ register. Licenciamento+ is the portal for applications, fee payments, submission of supplementary documents, decisions and electronic certificates.

The main legal sources are the Legal Regime of Human Medicinal Products, Decreto-Lei n.º 176/2006, and the Legal Regime of Retail Pharmacies, Decreto-Lei n.º 307/2007; manufacturing must also be coordinated with the industrial operating licence.

— INFARMED: business operations, product AIMs and controlled substances.

— DRE: official legal texts.

— IAPMEI or the relevant municipal authority: industrial operating licence.

A new pharmacy must first go through a competitive procedure; it may open to the public only after INFARMED issues an alvará. Eligibility, location and documentation must be confirmed against the current notice and Portaria.

A pharmacy may supply products to the public within the legally prescribed scope, but may not wholesale or export medicines; a retail alvará does not replace wholesale authorisation.

— New establishment: competitive procedure, fulfilment of premises and staffing requirements, and obtaining an alvará.

— Direct procurement: limited to eligible healthcare service entities for their own use.

Wholesale distribution means supplying, holding, storing or providing medicines for processing, resale or healthcare services, excluding supply to the public. INFARMED authorisation is generally required, and is limited to the authorised activities and premises.

Applicants must comply with GDP; premises are generally inspected before operations begin, and, following a satisfactory inspection, a GDP certificate is issued and the premises are entered in EudraGMDP. Inspection arrangements for premises covered by logistics operators should be verified on a case-by-case basis.

— Models: national market distributor or logistics operator.

— Requirements: technical management in Portugal, suitable premises and equipment, and evidence of GDP compliance.

— Exceptions: some manufacturers, importers and AIM holders follow an exemption or registration route.

All manufacturing, whether complete or partial, as well as repackaging, packaging and presentation, requires INFARMED manufacturing authorisation. The applicable industrial operating licence should be obtained first.

The application must specify the pharmaceutical form and manufacturing/control sites, and demonstrate technical management, licensed premises, equipment, control capabilities and GMP compliance; INFARMED inspects before making a decision, and authorisation is issued by pharmaceutical form.

— Circumstances requiring an update: commencement of activities, changes to manufacturing/quality-control activities, and a change of technical manager.

— Products manufactured solely for export and without a Portuguese AIM still require manufacturing authorisation.

The pharmacy’s technical manager must be a pharmacist and must continuously assume technical management responsibilities. INFARMED must be notified within 10 days of the start of the appointment; for a new pharmacy, the manager must be appointed before opening. When the manager leaves, a replacement pharmacist must be designated at the same time.

An ordinary pharmacy must have at least a technical manager and another pharmacist; the law states only that pharmacists “should preferably constitute a majority”. This must not be converted into a fixed ratio or full-time coverage requirement. A manufacturing technical manager must be a pharmacist specialising in pharmaceutical industry and registered with the Portuguese Pharmaceutical Society. Specific wholesale qualifications should be verified against the current form.

— Pharmacy manager: medicine instructions, storage, hygiene and safety, and statutory duties.

— Manufacturing manager: batch compliance, records, quality control and controlled-substance obligations.

Pharmacies must ensure the safety, storage and dispensing of medicines, as well as accessibility, convenience and privacy; they should have a service area, storeroom, laboratory and toilet. Zoning requires INFARMED approval and must be included in the alvará. Minimum floor area is prescribed separately by INFARMED regulations; this record does not specify figures.

Wholesale distribution requires suitable premises and equipment in Portugal; manufacturing requires licensed facilities, equipment and control capabilities. Both types of premises are subject to on-site inspection.

— Pharmacy construction, expansion, alteration of an approved floor plan or temporary relocation requires authorisation.

— Wholesale distributors should have GDP quality documents readily available.

Pharmacy, wholesale and related licensing matters must be submitted electronically via Licenciamento+. The portal provides forms for ownership, relocation, construction works, technical managers, and wholesale authorisations/changes.

For manufacturing, first obtain the industrial operating licence, then submit the manufacturing application and GMP documentation; wholesale applications focus on the business model, technical management, premises and equipment, and GDP. Electronic submission for a product AIM is a separate workflow.

— Pharmacy: fulfil the alvará requirements in accordance with the competitive-procedure notice.

— Wholesale: application, inspection, authorisation and GDP certificate.

— Manufacturing: industrial licence, application, prior GMP inspection and authorisation.

The Pharmacy Law provides for fees for review, inspection, alvará issuance and endorsements under a Portaria; the sources reviewed do not provide a current amount that can be applied generally, so no fee is stated.

For wholesale, a decision is generally made within thirty days following inspection or upon a valid application, but this is not a commitment to complete complex applications within that period; a GDP certificate is valid for up to five years. A GMP certificate for manufacturing is valid for up to three years, and renewal must be applied for at least six months in advance. The materials verified do not specify a general uniform validity period for manufacturing authorisations themselves.

— Controlled substances and medical cannabis require separate authorisations for the relevant activity or for each cross-border shipment.

— A product AIM timeline cannot be inferred from premises licensing.

Pharmacies must continuously meet requirements for technical management, premises, storage, hygiene and safety, and supply obligations; ownership, technical managers and locations are all subject to ongoing registration with INFARMED.

Wholesale distributors should maintain a quality system and quality manual and are subject to inspection; critical deficiencies may prevent them from operating. Routine GMP inspections of manufacturers follow a risk-based plan, and serious deficiencies may result in suspension of manufacturing authorisation and the GMP certificate.

— Wholesale: Apply for renewal and inspection before the GDP certificate expires.

— Manufacturing: GMP renewal must include an updated Site Master File.

— Products: AIM also entails pharmacovigilance and marketing-status obligations.

Changes to a pharmacy’s ownership or address must be annotated on the alvará; changes in ownership must be notified electronically within 30 days. The dissolution, merger or conversion of a company, and changes in shares or shareholding, must also be annotated; the appointment of the technical manager must be reported within 10 days of taking up the role.

A pharmacy relocation requires INFARMED authorisation and a favourable opinion from the municipal authority, and is subject to statutory distance and other conditions. As a rule, a pharmacy established through a competition may not be transferred or have its operating rights assigned within 5 years, except for legally justified reasons. Changes to wholesale details, and the commencement, suspension or cessation of activities, must be notified within 30 working days. Changes to manufacturing/quality-control or technical managers require an update to the manufacturing authorisation.

— Transaction due diligence: Verify the alvará, registrations, technical manager and premises.

— Wholesale: Check the scope of the annexes and submit declarations by the applicable deadlines.

— Manufacturing: First assess whether the authorisation annexes are affected.

Human medicines marketed in Portugal must, as a rule, have a valid AIM or registration. Routes include national, mutual-recognition, decentralised and EU centralised procedures. An AIM is a product assessment, not a licence to operate premises.

Imports from third countries require INFARMED authorisation and may generally be carried out only by holders of a manufacturing/import authorisation; imported batches must also generally undergo control and release in the EU. Products manufactured for export that do not have a Portuguese AIM still require manufacturing authorisation.

Each activity involving substances in Tables I to IV—including cultivation, manufacture, wholesale, import, export and transit—requires separate authorisation; each cross-border consignment also requires an official certificate. Authorisation for medical cannabis is granted for a maximum of 1 year and must be maintained annually. Active-substance manufacture, import and wholesale also require registration.

— Products: First determine the AIM/registration route and holder.

— Cross-border: Arrange third-country imports, manufacturing for export and controlled-substance certificates separately.

— Direct procurement: Authorisation is granted to a facility and is non-transferable; controlled medicines still require separate authorisation.