Poland Pharmaceutical Licensing

Medicines activities in Poland should be considered separately: ordinary pharmacies supplying the public, medicines wholesale not supplying the public, and the manufacture of medicines or imports from outside the European Union/European Economic Area. Ordinary pharmacies are under the jurisdiction of the WIF for their location; wholesale and manufacturing/import are under the jurisdiction of GIF. Obtaining one of these authorisations does not automatically grant either of the other two.

The government business services page describes applicants for an ordinary pharmacy as pharmacists holding the right to practise and lists certain business arrangements. Public sources do not directly explain how foreign investors, foreign pharmacist qualifications or complex control structures meet the requirements; this guide therefore makes no determination on foreign ownership eligibility.

— Retail: ordinary pharmacy operating licence; WIF for the pharmacy’s location.

— Wholesale: medicines wholesale authorisation; GIF.

— Manufacturing/import: authorisation to manufacture or import medicines; GIF.

— Product: marketing authorisation is handled separately by the President of URPL.

GIF supervises and controls the manufacture and marketing of medicinal products, and issues authorisations for the wholesale, manufacture, or import of medicinal products. An application to operate a community pharmacy must be submitted to the WIF for the location; the WIF reviews the premises and makes the decision.

Under the national procedure, marketing authorisation for a product is handled by the President of URPL; that product authorisation is separate from authorisation for business premises or manufacturing.

— Main legal basis: the 2001 Pharmaceutical Law (Prawo farmaceutyczne), cited on all relevant official service pages.

— Administrative procedures for wholesale and manufacturing/import are also subject to the Code of Administrative Procedure; detailed GDP, GMP, and application-format requirements are supplemented by ministerial regulations.

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Before opening a community pharmacy, an application for authorisation must be submitted to the WIF for the location. The official page states that the applicant must be a pharmacist with the right to practise and that the pharmacy must have a manager. The number of existing pharmacies, group concentration, and the relationship with wholesale or intermediary activities are also matters for review.

As a general rule, each pharmacy in the municipality must serve at least 3,000 residents, and the straight-line distance from other community pharmacies must be at least 500 metres. The foregoing two requirements may be waived if the straight-line distance from the proposed site to the entrance of the nearest existing community pharmacy is at least 1,000 metres. Follow the WIF's determination for the specific address and any exceptions.

A community pharmacy may sell non-prescription medicines remotely, but must notify the WIF no later than 14 days before commencing. Opening hours are determined through the local county council mechanism and are not uniform nationwide.

— The application specifies the business operator, registration/identification details, pharmacy address and name, proposed opening date, opening days and hours, and other information.

— The WIF reviews the technical plans and description of the premises and inspects the premises. Where applicable, documents evidencing the manager's qualifications and the lawful right to occupy the premises must also be attached.

— If the pharmacy has not opened within four months of authorisation being granted, the authorisation may be revoked.

Wholesale of medicinal products includes activities such as obtaining, storing, supplying, or exporting medicinal products, but excludes direct supply to the public. GIF issues authorisations under Article 74 of the Pharmaceutical Law; each wholesale premises requires a separate application and is entered in the register after approval.

The application dossier includes a manager's declaration, recall procedure, evidence of rights to the premises, technical description and plans, and the opinion of the sanitary inspectorate. GIF may request supplementary documents, seek information from other authorities, or conduct an inspection. Temperature control, segregation, falsified, expired, withdrawn, suspended, or export-only products must be managed in accordance with GDP.

— Submit paper documents to GIF or electronic documents through e-Doręczenia; electronic copies must be certified as required.

— The period to remedy a formal deficiency must be no less than 7 days from service; failure to remedy it may result in the application not being considered.

— The official processing period for a wholesale authorisation application is 90 days from submission of the application; periods for remedying deficiencies, providing explanations, or suspension are excluded, and it may be extended by up to 60 days in justified circumstances.

Manufacturing includes receipt of materials, production, packaging or repackaging, storage/distribution within the scope of the application, and related controls. Import means bringing medicinal products into the country from outside the European Union or European Economic Area, including storage, quality control for batch release, and distribution. Both activities require authorisation from GIF.

GIF may authorise an application scope that includes medicinal products intended solely for export, intermediates, bulk products, investigational medicinal products, and certain raw materials. The applicant must demonstrate compliance with the requirements through documentation concerning the premises, equipment, QP, and GMP; the authorisation is separate from marketing authorisation for individual products.

— Main attachments: a site master file prepared in accordance with GMP, a list of the names/strengths/pharmaceutical forms of products to be manufactured/imported, and proof of payment of the application fee.

— It is recommended to attach QP employment information, a KRS extract, and contact details. GIF's page also requires information about the QP's education, experience, responsibilities, and place of work.

— The official processing period is 90 days from submission of the application; periods for providing supplementary documents, explanations, or suspension are excluded.

A community pharmacy must have a manager. The official page specifies that the manager must be a pharmacist and meet requirements such as a specialisation plus two years of full-time experience in a community pharmacy, or five years of full-time experience in a community pharmacy, as well as fulfil continuing professional development and pharmacist self-governance obligations.

Manufacturing/import requires a QP; GIF requires information about the QP's employment, education, experience, responsibilities, and place of work. A general wholesale application must include a manager's declaration; the public page does not state uniform education/experience figures applicable to all general wholesale applications.

— Wholesale of controlled substances additionally requires the person responsible for supervising that business to have the qualifications listed officially, including two years of wholesale or pharmacy work experience, a pharmaceutical degree, the right to practise, and a declaration of appointment.

— This person may not also serve as the general wholesale manager of the wholesale enterprise that employs them; this is a specific condition for controlled-substance applications and should not be generalised as a staffing-ratio requirement for all businesses.

A public pharmacy must be separated from other premises and activities. The official page states a minimum basic area of 80 square metres; 60 square metres applies to locations with a population of no more than 1,500 and to rural areas, and it sets out the corresponding basic and ancillary areas. Health, fire-safety and occupational-safety rules must also be met.

Wholesale premises must comply with GDP; GIF specifically recommends submitting temperature mapping, qualification of cold-chain equipment where applicable, temperature-deviation procedures, supplier/customer qualification and transport procedures. Manufacturing/import premises must have suitable rooms, technical and control equipment, as described in the GMP Site Master File. GIF conducts a planned GMP inspection at least once every 3 years; an ad hoc inspection may be carried out in risk situations.

— Pharmacy premises must be assessed by WIF for the technical design and suitability of the site.

— Wholesale loading and unloading areas may be outside the wholesale premises, but their rooms must meet the technical requirements for wholesale premises and be declared in the application or amendment.

— Public sources do not provide a single nationwide floor-area figure applicable to all wholesale or manufacturing facilities; accordingly, no such figure is specified here.

A public pharmacy applies to the WIF for its location. The WIF reviews the application, responsible person and premises documentation, and assesses the premises. Applications for wholesale and manufacturing/import are submitted to GIF; both are subject to an initial formal and substantive review. The deadline to remedy formally identified deficiencies is at least 7 days, and GIF may request further evidence or conduct an inspection.

The applicant’s company registration details, signing authority, powers of attorney and electronic authentication must be consistent. For manufacturing/import, applicants should also pay attention to the company and site information in EMA OMS; GIF notes that failure to register or update these details may prevent authorisation information from being entered in EudraGMDP.

— Retail: entity and identification details, address, name, opening date/business hours, responsible person’s qualifications, rights to the premises and technical documentation.

— Wholesale: responsible person, recall procedure, rights to the premises, technical drawings, sanitary opinion and GDP documentation.

— Manufacturing/import: GMP Site Master File, product list, QP details, evidence relating to premises/equipment and proof of fee payment.

The initial public pharmacy authorisation fee is calculated at five times the minimum wage; the government page lists the 2026 minimum wage as 4,806 zlotys. The standard processing period is no more than 1 month; complex matters may take up to 2 months.

The initial wholesale authorisation processing period is 90 days. Time is suspended while additional documents or explanations are awaited or during a suspension, and may be extended by up to a further 60 days in justified circumstances. The fee is calculated under a ministerial regulation; the service page does not show a fixed total amount. The initial manufacturing/import authorisation processing period is 90 days.

The manufacturing/import service page publicly lists application fees of 2,300 to 7,800 zlotys, depending on scope; these do not include premises, inspection, translation, consultancy or other costs. No standard renewal cycle for public pharmacy or general wholesale authorisations is listed on the pages reviewed.

— Amendment to a wholesale authorisation: the GIF page lists a 30-day processing period, which may be extended by up to a further 60 days in justified circumstances.

— Amendment to a manufacturing/import authorisation: the GIF page lists a 30-day processing period, which may be extended by up to a further 60 days in justified circumstances.

— Wholesale of controlled substances: the official page lists a 30-day processing period; wholesale authorisations for narcotic drugs/psychotropic substances are issued for an indefinite period, and a Category 1 precursor licence is valid for 3 years.

A public pharmacy must meet local demand for medicines; if it persistently fails to do so, WIF may withdraw the authorisation. GDP continues to apply to wholesale, and GMP to manufacturing/import. At least one planned GMP inspection is conducted every 3 years; ad hoc inspections may be carried out in risk situations.

Public sources do not confirm a uniform annual review or renewal regime applicable to the 3 main authorisation types, so none is specified. On cessation of wholesale or manufacturing/import operations, an application must be made to GIF for a decision declaring the authorisation expired, with arrangements for inventory, records/samples and archive retention submitted.

— After cessation of wholesale operations, an application for a decision declaring the authorisation expired must include inventory, transaction records, the location where any remaining inventory will be stored and arrangements for retaining records for at least 5 years.

— After cessation of manufacturing/import operations, an application for a decision declaring the authorisation expired must describe sample storage, retention of batch records and arrangements for retaining manufacturing/import records for at least 5 years.

— Import/export of controlled substances also entails specific obligations, including single-crossing documents, return of documents and annual reporting.

Changes to public pharmacy authorisation details, such as the entity or address, require an application for amendment to the WIF for the location, accompanied by supporting documents. The usual processing period is no more than 1 month; complex matters may take up to 2 months.

Changes to wholesale details must be notified to GIF by applying for an amendment within 14 days. The usual processing period is 30 days and may be extended by up to a further 60 days in justified circumstances. A manufacturing/import amendment must include an updated GMP Site Master File, product list and supporting documents; the usual period is also 30 days and may be extended under the applicable rules.

— If a wholesale or manufacturing/import business is deleted from KRS/CEIDG or ceases operations, its authorisation expires and the GIF procedure for a decision declaring it expired should be followed.

— The national-level retail page reviewed for this guide states that a “change of operating entity” requires an amendment application, but does not provide a uniform automatic-transfer rule covering all share or asset transaction structures.

— Accordingly, before an acquisition, merger, division, change of control or standalone pharmacy sale, obtain written confirmation from the relevant WIF/GIF as to whether an amendment, transfer or new application is required. This guide does not assert that a licence automatically transfers with a transaction.

Under the national procedure, where the same medicinal product is not authorised for marketing in any EU or European Economic Area country, the product-responsible party must apply to the President of URPL for a marketing authorisation. This authorisation is normally valid for 5 years; the procedure for a complete application should not, in principle, exceed 210 days. It does not replace an operating authorisation.

“Import” in a manufacturing/import authorisation refers specifically to bringing medicinal products in from outside the EU or European Economic Area. Wholesale of narcotic drugs, psychotropic substances and Category 1 precursors requires separate GIF authorisations or licences; import/export of controlled substances also requires a separate permit, which authorises only a single crossing of the Polish border.

— National product marketing authorisation: apply to the President of URPL; applicable product information, quality/non-clinical/clinical documentation and pharmacovigilance information are required.

— Import from a third country: this must be included in the scope of the GIF manufacturing/import authorisation, with appropriate import, quality-control, release and storage capabilities.

— Controlled substances: in addition to a general wholesale authorisation, separately verify the relevant GIF wholesale authorisation/licence and the import/export permit for each consignment.