Hungary Pharmaceutical Licensing

This record covers only the retail, wholesale and manufacture/import of human medicinal products. It does not cover financial licences, veterinary medicines or medical devices. NNGYK centrally handles pharmaceutical authorisations; municipalities receive notices of pharmacy decisions, but this verification did not identify a separate provincial/state pharmaceutical licensing system.

Wholesale applicants may be business organisations or Hungarian branches of foreign companies. Pharmacy rules apply across all ownership forms; the materials reviewed are insufficient to summarise foreign ownership, capital or corporate-form rules that apply universally to retail or manufacturing.

— Retail, wholesale, manufacturing, products and cross-border activities must be verified separately.

— Do not extrapolate an individual right to operate a pharmacy into a general business requirement.

The NNGYK pharmacy department is responsible for the establishment, operation, registration and supervision of community, branch, hand-held and institutional pharmacies; its pharmaceutical functions also cover manufacturing and wholesale. The principal laws are the 2006 Pharmacy and Distribution Act, the 2005 Act on Medicinal Products for Human Use, and their implementing regulations.

Non-pharmaceutical prerequisites, such as construction, labour, fire safety and customs requirements, are not automatically satisfied by obtaining an NNGYK decision.

— NNGYK: authorisations, inspections and registration.

— National legislation database: texts of legislation in force.

In principle, a new pharmacy must first obtain an establishment permit and an operating permit. New community pharmacies are established through a national tender in circumstances specified by law; procedures for community, branch and hand-held pharmacies must not be conflated. The individual right to operate a pharmacy is a separate authorisation for pharmacists with relevant professional experience, relating to a specific community pharmacy.

Shops outside pharmacies may sell only medicinal products classified as “gyk” in the competent authority’s database and in authorised pack sizes; this does not permit the sale of all non-prescription medicines.

— A pharmacist must be physically present throughout a pharmacy’s opening hours.

— Verify establishment, operation and the individual right to operate separately.

Except for statutory exceptions, wholesale of medicinal products for human use requires a valid NNGYK wholesale authorisation; manufacturers may wholesale their own products under their manufacturing authorisation. The process includes application, review, any necessary on-site inspection, corrective action and a decision.

The application must specify the product groups, temperature control, premises, responsible person, quality system, SOPs, recall and sales suspension procedures, receipt, dispatch and returns, equipment, and layout plan. Wholesale activities must comply with GDP and are subject to risk-based inspections.

— The authorisation does not cover undeclared premises or arbitrary product categories.

— Quality release, records and corrective action are ongoing requirements.

A manufacturing authorisation covers manufacturing, packaging, quality control, batch release, stock distribution and, where provided for by law, import from third countries. NNGYK issues authorisations only for the premises, medicinal products/dosage forms and activities applied for.

A decision is made following administrative review, an on-site GMP inspection, a report and any necessary corrective action; the applicant must demonstrate that its personnel and facilities can ensure the product meets marketing authorisation requirements.

— Submit the activity scope, premises/layout plan, QP evidence and liability insurance.

— Assess whether an amended authorisation is required before expanding activities, processes or premises.

A pharmacist must be physically present at a community pharmacy during its opening hours; the individual right to operate a pharmacy is not equivalent to ordinary company director qualifications, and recognition of foreign qualifications must not be assumed.

A manufacturer must continuously have at least one QP. Regulations specify relevant university education and generally two years of quality assurance practice; NNGYK assesses the supporting evidence and records the QP in the authorisation. A wholesale responsible person must generally also demonstrate one year of wholesale quality assurance practice.

— Retail: pharmacist presence and the individual right to operate a pharmacy are related but distinct.

— Wholesale: each operating warehouse must have a responsible person.

— Manufacturing: the QP is responsible for quality assurance and batch release.

The minimum usable area for a community pharmacy is 80 square metres, including at least 20, 12 and 10 square metres respectively for the service area, laboratory and storeroom, with requirements for a patient entrance and functional rooms; these figures must not be applied to wholesale warehouses or manufacturing plants.

Wholesale applications must include a facility layout plan and equipment description. Manufacturing premises must match the approved activities, GMP requirements, staffing, equipment and quality control; products requiring special temperature control or aseptic processing, among other requirements, must be designed for according to the actual scope.

— Retail is subject to premises rules specific to pharmacies.

— Wholesale requires GDP controls for warehousing, segregation and logistics.

— An office address cannot be substituted for manufacturing premises.

An application to establish a new pharmacy must include at least the type, address, planned opening date, service hours, sales scope and technical design; for a community pharmacy, first verify whether a tender is required. Prepare separately for the operating permit, establishment permit and individual right to operate.

Wholesale applications to NNGYK must include materials such as details of the responsible person, premises, quality system, SOPs and liability insurance; manufacturing applications must use the statutory forms and include the activity scope, premises, QP and insurance. Both may involve requests for supplementary information and on-site inspections.

— First define the business and premises.

— File personnel, premises, quality systems, and product/cross-border documentation separately.

— Conduct activities only within scope after the formal decision takes effect.

NNGYK fee documents list authorisation, amendment, and inspection fees charged per site separately; the table below excludes costs for corrective actions, translation, consultants, construction, or other authorities. The statutory decision period for manufacturing authorisation is 90 days, but inspections, supplementary submissions, and other factors affect the actual timeframe.

The materials reviewed did not establish a uniform expiry/renewal date for the three types of business authorisation. GDP/GMP certificates, product marketing authorisations, and business authorisations are not interchangeable.

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A pharmacy must maintain its approved personnel, premises, service hours, and scope of sales. It may suspend operations for up to 21 days per calendar year; a planned suspension must be reported at least one month in advance, and unplanned suspensions are also subject to immediate/next-day reporting rules.

Wholesalers are subject to risk-based GDP inspections; the fact that five years have elapsed since the inspection date shown on a GDP certificate does not, by itself, invalidate a valid wholesale authorisation. Manufacturing must remain compliant with GMP; NNGYK states that inspections are generally carried out at intervals of no more than 3 to 5 years, and quality issues may trigger special inspections, suspension, or revocation. A production stoppage lasting more than six months must be notified at least three months in advance.

— Retail: maintain pharmacist presence and comply with the particulars recorded in the authorisation.

— Wholesale: GDP, responsible person, records, and corrective actions.

— Manufacturing: GMP, QP, quality defects, and recalls.

For a pharmacy, planned changes that affect the conditions or information recorded in the operating authorisation must be reported in writing in advance; unforeseeable events must be reported within five working days of becoming known. Amendments to the company agreement must be submitted within 30 days; if they affect information that must appear in the authorisation, the authorisation must also be amended. Transfer of the personal right to operate requires the authority's approval, the company's consent, and amendment of the operating authorisation.

For wholesalers, adding a site/warehouse, expansion, or a change of responsible person or medicinal-product group requires an amendment to the authorisation; certain changes to the name and contact details must be reported immediately. Appointment or termination of a QP in manufacturing requires an immediate application to amend the authorisation; changes to information subject to a statutory notification requirement must also be reported immediately. The authority decides on amendments within 30 days.

— Before a transaction, verify the legal entity, premises, personnel, scope, and notes.

— Include notifications, amendments, and any required inspections as closing conditions.

Except where a statutory exception applies, a product must first obtain marketing authorisation from the Hungarian competent authority or the European Commission; retail, wholesale, and manufacturing authorisations do not automatically confer marketing authorisation for each SKU.

Parallel imports require a separate application to NNGYK and submission of information on the country of origin, the corresponding Hungarian product, Hungarian-language labelling/package leaflet, and any necessary repackaging documentation. Imports from third countries generally fall within the scope of manufacturing authorisation; a wholesale authorisation holder may qualify for an exception only under a separate import authorisation. Production involving narcotic drugs, psychotropic substances, or controlled precursors also requires a special authorisation.

— Products: verify marketing authorisation, packaging language, and supply chain.

— Cross-border: distinguish parallel import, third-country import, repackaging, and batch release.

— Controlled drugs: separately verify special authorisations and records.