Spain Pharmaceutical Licensing

This record is limited to pharmacies, wholesale and manufacture/import of industrialised medicinal products for human use in Spain. General company formation, tax, local construction/business, employment and individual registration procedures have not been verified item by item.

Pharmacies dispense to the public; wholesale excludes dispensing to the public; manufacturing/import laboratories are limited to their authorised activities, sites and dosage forms. Placing industrialised medicinal products on the market also requires a separate marketing authorisation/registration or applicable EU authorisation.

— Do not treat company registration as authorisation of a medicinal product business.

— Do not treat authorisation of an entity/premises as authorisation for products, imports, exports or controlled drugs.

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AEMPS authorises manufacturing/import laboratories and customs-controlled medicinal product warehouses, and publishes information on laboratories, distribution entities and GMP/GDP matters.

The autonomous communities are not AEMPS service counters: they are responsible for pharmacy planning and establishment decisions, and authorise ordinary/contract wholesale warehouses. For operations in multiple locations, confirm the responsibilities applicable to the warehouse location and the place where activities are actually carried out.

— National common framework: Royal Legislative Decree 1/2015.

— Basic law on pharmacies: Law 16/1997.

— Wholesale of medicinal products for human use: Royal Decree 782/2013 and EU GDP.

A pharmacy is a private healthcare establishment serving the public interest and providing services including the acquisition, safekeeping, preservation and dispensing of medicines to the public. Ordinary retail, online sales and veterinary medicine retail are not necessarily covered by this record.

The autonomous communities plan pharmacy provision according to population, geography and service accessibility. The general legal benchmarks are 2,800 residents per pharmacy and a 250-metre separation; autonomous communities may adjust these within the scope of the law and establish procedures for measurement, areas, establishment, relocation and transfer.

— Establishment authorisations are handled and decided by the autonomous communities.

— A pharmacy may be transferred only to one or more pharmacists.

— A pharmacist's presence during business hours cannot be replaced by an assistant.

Distribution means the acquisition, storage, safekeeping, supply or export of medicines, expressly excluding dispensing to the public. Wholesale, contract and customs-controlled warehouses all require prior authorisation, which must reflect the actual distribution activities.

Ordinary/contract warehouses are authorised by the autonomous community where they are located; activities in other autonomous communities must be notified as required by law. Customs-controlled warehouses are authorised by AEMPS, and all entities must also notify AEMPS when commencing activities.

— A pharmacist must serve as the technical manager.

— GDP must be observed.

— A contract warehouse must first obtain contract warehouse authorisation.

Manufacturing medicinal products or any stage of their manufacture (including repackaging, packaging or presentation for sale) requires prior AEMPS authorisation; manufacture solely for export is not exempt. Laboratory activities related to imports from third countries also require the corresponding authorisation.

AEMPS assesses and inspects the applicant before authorisation. The application must define the products, dosage forms, sites and scope of manufacture/control, and provide for suitable premises and equipment, a technical manager, a manufacturing manager and a quality control manager.

— A contract manufacturer/controller must be authorised, and AEMPS must specifically authorise contract manufacturing.

— Authorised laboratories are subject to periodic GMP inspections.

— Active pharmaceutical ingredients generally fall under RUESA and do not automatically require authorisation as a finished medicinal product laboratory.

Pharmacy dispensing must be carried out under the responsibility of a pharmacist present on site; the autonomous community may set the number of additional pharmacists according to activity volume, type and opening hours. A wholesale entity must have a pharmacist as its technical manager.

Manufacturing/import laboratories must have technical, manufacturing and quality control managers. AEMPS application requirements call for evidence of the technical manager’s qualifications, experience, incompatibilities and employment relationship, but this record does not invent specific experience periods.

— There is a limited exception for the quality control function only in the case of small batches/simple products.

— Manufacture of controlled active pharmaceutical ingredients requires additional AEMPS authorisation.

Pharmacy locations are subject to autonomous community planning and authorisation to open or relocate; the general population and distance framework in the law does not replace local measurements or technical requirements.

Wholesale premises and equipment must ensure proper storage, cold-chain maintenance, continuity of supply, recalls and alerts; manufacturing/import operations require adequate and appropriate manufacturing, control and storage facilities and are subject to AEMPS inspection.

— Do not infer nationally uniform pharmacy floor-area or fit-out standards.

— Customs storage is not the same as an ordinary warehouse; it must be provided by an authorised customs warehouse.

A pharmacy applies to the autonomous community where it is located; national law confirms its authority to process and decide applications and the principles of public transparency, but does not provide a single nationwide list of required attachments.

Wholesale operations/contract warehouses apply to the autonomous community where they are located, and customs warehouses apply to AEMPS; confirm local document lists, application channels and inspection arrangements with the relevant authority.

Manufacturing/import applications are made through LABOFAR. The official requirements specify, among other things, the applicant/representative, corporate information (if applicable), a technical description, evidence relating to the technical manager and proof of fee payment; applications are assessed and inspected.

— First define the site, dosage forms and scope of manufacture/control.

— A catalogue search does not replace a new application or approval of a variation.

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A laboratory application must include proof of payment of the statutory fee. AEMPS publishes a maximum notification period of 90 days for initial applications; laboratory variations take 30 days, with exceptions extendable to 90 days. Requests for further information and inspections may affect the actual timeline.

Fees, processing times, local renewal or inspection arrangements for pharmacies and ordinary/contract wholesale operations are not nationally uniform figures in the official sources consulted for this review and must not be invented.

— Initial laboratory procedure: maximum notification period of 90 days.

— Laboratory variation: 30 days, or 90 days in exceptional cases.

— No fixed fee, approval date or expedited processing is promised.

Pharmacies must continuously meet the requirements for a pharmacist to be present and comply with the autonomous community’s rules on opening hours, on-call duties and emergency services. Wholesale operations and laboratories carrying out direct distribution should follow GDP, including requirements for storage, cold chain, inventory, recalls and alerts.

Manufacturing/import laboratories must continuously comply with GMP, quality control, inspection cooperation and supply obligations. Laboratory registration is updated in line with authorisations/variations; revocation or suspension of an authorisation is reflected in the registration status.

— A one-time authorisation does not remove ongoing obligations.

— Controlled medicines are subject to separate records and specific controls.

A pharmacy may be transferred only to a pharmacist; the method, conditions and time limits are determined by the Autonomous Community. Do not assume that a pharmacy authorisation is automatically completed through an ordinary company or asset transaction.

Material changes to wholesale premises, equipment or activities, or relocation, require prior authorisation. Changes to the scope or location of a manufacturing/import authorisation require prior approval from AEMPS; replacement of the technical director must be notified to AEMPS and the relevant Autonomous Community.

— Changes to, transfers of and termination of a product marketing authorisation must be reflected in the medicinal product register.

— National sources do not confirm that an establishment authorisation is automatically inherited through a share transaction.

Before industrially manufactured medicinal products are placed on the market, they must have an AEMPS authorisation and registration or an applicable EU authorisation. Changes to strength, pharmaceutical form, route, packaging and other product particulars are handled under the product rules. Marketing authorisation holders must also report the date of first marketing and the product’s commercialisation status.

Finished medicinal products imported from third countries must be handled by an authorised importer laboratory. Imports of medicinal products and investigational medicinal products require prior AEMPS authorisation. Storage under customs-suspensive procedures must take place in an authorised customs-controlled warehouse.

Depending on the product and transaction, exports are subject to prior notification to or authorisation from AEMPS. Each export of a registered human medicinal product in finished form must be notified through LABOFAR at least three working days in advance; do not extend this requirement to all exports. Narcotic and psychotropic substances are subject to separate AEMPS import/export and record-keeping requirements.

— Verify products using the AEMPS product register/CIMA, rather than checking only the establishment.

— Verify imports, batch responsibilities, destination and controlled status item by item.