Slovakia Pharmaceutical Licensing

This record covers only retail sales of human medicinal products through public pharmacies, wholesale distribution of human medicinal products and manufacture of human medicinal products in Slovakia. Act No. 362/2011 on Medicinal Products and Medical Devices classifies manufacturing, wholesale distribution and pharmaceutical care as distinct activities involving the “handling of medicinal products”; natural and legal persons must obtain the relevant authorisation under that Act before engaging in them.

A business authorisation is not equivalent to product registration, a professional licence, parallel import approval or a permit for narcotic/psychotropic substances. Veterinary medicines are governed by separate authorities and rules and are outside this guide to human medicines. Official sources do not establish a basis for asserting uniform capital, corporate-form, foreign-investment or premises-area thresholds; verify these with the competent authority.

— Public pharmacy/branch for human medicinal products: authorisation by the self-governing region.

— Wholesale distribution of human medicinal products: ŠÚKL authorisation, subject to GDP requirements.

— Manufacture of human medicinal products: ŠÚKL authorisation, subject to GMP requirements.

Licensing responsibilities in Slovakia are divided by activity: Articles 6 and 7 of the Medicinal Products Act designate ŠÚKL to handle manufacturing and wholesale distribution of human medicinal products; public pharmacies and branches are handled by the self-governing region where they are located, while hospital pharmacies are handled by the Ministry of Health.

E-government services provide for applications to issue, amend, suspend and revoke authorisations for public pharmacies, branches and medical-device dispensing outlets. Applicants should select the self-governing region corresponding to the premises and should not present the practice of one region as a uniform nationwide procedure.

— ŠÚKL: Responsibilities relating to the manufacture and wholesale distribution of human medicinal products, product registration and pharmaceutical inspections.

— Ministry of Health: Separate authorisation matters for hospital pharmacies and controlled narcotic and psychotropic substances.

— Self-governing regions: Authorisation to provide pharmaceutical care through public pharmacies and branches.

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Applications for authorisation to provide pharmaceutical services at public pharmacies and their branches must be submitted to the self-governing region where the premises are located. The e-Government service provides for applications for new authorisations, amendments, suspensions and revocations. Holders may handle medicinal products and medical devices only after obtaining authorisation.

A branch is not simply an additional outlet: it may be established only in a municipality that does not already have a public pharmacy, and must be within the jurisdiction of the self-governing region that issues the authorisation. Internet dispensing may likewise be carried out only by an authorised public pharmacy or medical-device dispensing outlet, under special conditions, through its website or application.

— Public pharmacy: provides pharmaceutical services to the public and may prepare individual formulations as permitted by law.

— Public pharmacy branch: subject to statutory restrictions on location and scope of services.

— Hospital pharmacy: not covered by this retail authorisation route; applications must be made to the Ministry of Health under the rules for hospital pharmacies.

An application for a wholesale distribution authorisation for human medicinal products must be submitted to ŠÚKL. Under Section 17 of the Medicines Act, in addition to meeting the general requirements, an applicant must demonstrate that its premises and equipment comply with health requirements and Good Distribution Practice, and appoint a person responsible for wholesale distribution who has completed second-cycle higher education in pharmacy. The application must also specify the place of business and the geographical area of distribution.

Wholesale authorisation holders have ongoing obligations, including keeping GDP documentation, allowing state supervision and carrying out recalls as ordered. For imported medicinal products, the statutory information must be submitted within seven days of import. For human medicinal products supplied to domestic or foreign markets, the quantities and types must be reported within seven days after the end of each quarter. ŠÚKL has published application forms and guidance for wholesale authorisations and amendments.

— A wholesale authorisation covers only the activities and scope stated in the authorisation.

— Different provisions may apply to medicinal gases, veterinary medicinal products and brokering; the personnel requirements in this section should not be applied to them without verification.

— Procurement from compliant suppliers, temperature and humidity controls, and traceability documentation should be incorporated into the GDP system.

ŠÚKL issues manufacturing authorisations for human medicinal products. The Medicines Act requires manufacturing premises to comply with GMP and health requirements, and to have either an in-house quality control laboratory or a written agreement with a holder of a medicinal product manufacturing authorisation covering the relevant approved activities. Premises must also be available for collecting, processing and retaining data and information on medicinal products placed on the market.

ŠÚKL explains that its inspection department issues an opinion on the applicant’s materials, premises and equipment, and staffing arrangements; this opinion is an attachment to the manufacturing authorisation application. A manufacturing authorisation also requires separate persons responsible for manufacturing and quality assurance. Their qualifications must be checked against the relevant professional education, experience or specialist qualification routes under Section 12 of the Medicines Act.

— First obtain ŠÚKL’s opinion on the manufacturing premises and personnel, then submit it with the manufacturing authorisation application.

— The manufacturing scope, dosage forms, processes and specific descriptions of import/manufacturing activities should match the application.

— GMP compliance and marketing authorisation for a product are parallel, not interchangeable, requirements.

As a general rule, a natural person without professional qualifications may appoint at least one professionally qualified person responsible for professional work relating to the authorised activities; a legal entity must also appoint at least one professionally qualified person. The responsible person and the relevant entities must meet the integrity, criminal-record and qualification requirements under the Medicines Act. The application must include the relevant identity, qualification and criminal-record documentation.

The statutory professional qualifications for public pharmacies are more specific: the responsible person must have completed second-cycle higher education in pharmacy and have at least five years’ experience in a public or hospital pharmacy, or hold a specialist qualification in pharmacy. The person responsible for wholesale distribution must have completed second-cycle higher education in pharmacy. Different professional and experience pathways under Section 12 apply to manufacturing and quality assurance responsible persons; these requirements cannot simply be described as a generic “pharmacist” requirement.

— Where the responsible person is an employee, the application must generally include an employment contract; an exception is provided by law if that person is also the applicant’s statutory representative or a member of its statutory body.

— If the responsible person leaves, a temporary replacement may be appointed for a maximum of 60 days, and a further replacement may not be appointed after that period expires.

— This record does not contain sufficient official guidance on individual procedures for recognition of foreign qualifications, professional licences and language requirements to support a uniform conclusion.

All authorisation applications must specify the place of business and include proof of the right to use or ownership of the premises. Applications relating to human medicinal products must also include a favourable ŠÚKL opinion on materials, premises and equipment, and staffing arrangements, as well as a decision by the public health authority permitting the premises to begin operation, or a statutory substitute document. The application must also include a binding opinion from the municipality on opening the premises.

The list of documents for ongoing public pharmacy inspections shows that regulators examine authorisation documents; the responsible person’s licence and employment relationship; a floor plan with measurements confirmed by an authorised architect; lease/ownership documents; hygiene and cleaning procedures; temperature and humidity records; and records relating to calibration/verification of measuring instruments. This is an inspection-document checklist, not a nationwide floor-area figure set by this guide.

— Retail: Prepare layouts, operating procedures and storage records appropriate to the actual pharmacy format.

— Wholesale distribution: Premises and equipment must meet GDP and health requirements.

— Manufacturing: Premises must meet GMP, health, quality-control and records-management requirements.

Statutory application documents include information on the applicant, representative/responsible person, scope of activities, location and rights to the premises, commencement date, qualifications, ŠÚKL opinion, public health and municipal documents, criminal-record information and, where applicable, an employment contract. Manufacturing or import applications must also describe the categories of medicinal products, dosage forms and processes.

Retail pharmacies use the self-governing regions’ e-services; wholesale and manufacturing applications use ŠÚKL forms. The statutory decision period is 90 days for manufacturing/wholesale and 30 days for pharmaceutical services. Applicants may be required to complete missing documentation within 30 days; the period is suspended until the documents are provided.

— Determine the business activities and the competent licensing authority.

— Complete the prerequisite documents concerning premises, personnel, public health, the municipality and the ŠÚKL opinion.

— Submit using the current form issued by the relevant authority; allow project-management time for requests for additional information, inspections and system registration.

The legislation verified for this guide sets a 90-day decision period for manufacturing/wholesale and a 30-day decision period for pharmaceutical services; time taken to provide additional information when an application is incomplete is excluded from those periods. These are authority decision periods, not the total duration of a commercial project.

The official sources opened for this review on general human-medicinal-product retail, wholesale and manufacturing authorisations did not provide a current fee schedule that could safely be applied to all three types of business, all self-governing regions and every application scenario. Nor did the provisions verified specify a uniform authorisation expiry or renewal cycle. Accordingly, no fees, validity periods or renewal arrangements are fabricated; obtain the current fees and case-specific requirements from the relevant self-governing region or ŠÚKL. Fees for separate controlled-substance authorisations must not be substituted for business authorisation fees.

— Manufacturing/wholesale: statutory decision period of 90 days, subject to complete documentation.

— Pharmaceutical services at a public pharmacy: statutory decision period of 30 days, subject to complete documentation.

— Fees, expiry and renewal: verify against the current arrangements of the authority handling the application.

After an authorisation is issued, retail, wholesale and manufacturing activities must continue to comply with the approved scope and the requirements for premises and personnel. The pharmacy inspection checklist requires records of authorisations, personnel, layout, hygiene, temperature and humidity, calibration, stock, expiry and withdrawal, recalls, the supply chain and the movement of medicinal products.

Wholesale authorisation holders must maintain records in accordance with GDP, be subject to supervision, and fulfil import, quarterly reporting and recall obligations; manufacturers must continue to operate in accordance with GMP.

— Retail: quality, storage, records, disposal of expired products, withdrawals and personnel records.

— Wholesale: GDP, traceability, import/quarterly reporting, recalls and supervision.

— Manufacturing: GMP, quality control, quality assurance responsibilities and approved scope.

The authorisation holder must report without undue delay to the issuing authority any change in a natural person's name/address, a legal person's name/registered office, or its statutory representative. A new authorisation is required for a new type or scope of activity, a change of business premises or a change of the professional responsible person; the original authorisation is then revoked. In cases of serious infringement, the authority may suspend the activity for up to 90 days and order corrective action.

An authorisation attaches to its holder and may not be transferred except as provided by specific statutory provisions. It terminates on the holder's death, declaration of death or cessation of a legal person, and does not pass to a legal successor. Accordingly, it must not be assumed that a share transaction, asset transaction, merger or substitution of the legal entity automatically transfers a medicinal-products authorisation. Before a transaction, confirm with the original issuing authority the authorisation consequences of the specific proposed structure.

— Changes to general registration information: notify the issuing authority promptly so that it can record the changes in the authorisation.

— Changes to scope, location or professional responsible person: a new-authorisation process is required.

— Cessation of the legal entity: the authorisation does not pass to a successor; arrangements for disposing of stock must follow the authority's decision.

Product registration is a product-level decision authorising a medicinal product to be placed on the market and registered; it is not a business authorisation. All human medicinal products manufactured in batches must be registered. ŠÚKL is responsible for national, mutual-recognition and decentralised procedures; the European Commission decides on the EU centralised procedure. Traditional herbal medicinal products and homeopathic medicinal products may qualify for simplified registration, but this does not exempt the business from authorisation requirements.

Parallel import requires prior approval; the product may be sold only after approval. ŠÚKL states that the authorisation is valid for one year and that renewal must be applied for at least three months before expiry. Wholesale authorisation holders importing products must also submit batch information. In addition to general business authorisations, controlled or psychotropic substances require a separate Ministry of Health authorisation, an opinion from ŠÚKL and the relevant existing authorisation annex.

— Business authorisation: authorisation for an entity/premises to conduct retail, wholesale or manufacturing activities.

— Product registration: a decision on placing a product on the market; national, MRP, DCP and EU centralised procedures operate in parallel.

— Parallel import: separate approval required; controlled substances: separate authorisation from the Ministry of Health required.