Cyprus Pharmaceutical Licensing

This record covers retail sale, wholesale, manufacturing and third-country import of human medicinal products. Cyprus has a national-level pharmaceutical regime and applies to the Republic of Cyprus as described on Ministry of Health pages; areas outside that system have not been verified. Company registration is handled separately by the Registrar of Companies and does not replace pharmaceutical authorisation. Wholesale applications may be made by individuals or legal entities; pharmacy companies are subject to separate requirements for management and control by a registered pharmacist and at least 51% shareholding by that pharmacist.

— Retail: pharmacy registration.

— Wholesale: wholesale authorisation.

— Manufacturing/third-country import: manufacturing/import authorisation.

— Products, personnel and controlled drugs: separate authorisations.

The Pharmaceutical Services of the Ministry of Health are responsible for pre- and post-marketing oversight and inspections. The GMDP Inspection Department inspects GMP compliance by manufacturers/third-country importers and GDP compliance by wholesalers, reviews QP registration, and is responsible for quality sampling, recalls and related matters. The Pharmacy Board deals with pharmacies and pharmacists under the Pharmacy and Poisons Law, Cap. 254; the Drug Council issues wholesale and manufacturing/import licences.

— Human medicinal products: Law 70(I)/2001.

— Pharmacies and pharmacists: Cap. 254.

— Controlled substances: 1977 law and related rules.

A pharmacy must be registered with the Pharmacy Board. An individual must be a registered pharmacist; a company must meet the pharmacist management and control and minimum 51% shareholding requirements. The application is submitted through the Registrar. Core documents include pharmacist credentials, a lease or proof of ownership, building plans and permits; companies must also submit their articles, incorporation documents, and proof of shareholders, directors and secretary. A decision is made following three on-site inspections.

— The premises should be a stand-alone shop with accessibility arrangements.

— Prescription-only and controlled medicines must be supplied in accordance with a medical prescription.

— Only medicines with an MA in Cyprus may be sold.

A wholesale licence from the Drug Council must first be obtained to procure, hold, supply or export medicines/active substances for manufacturing. The application and premises inspection are prerequisites; the applicant must demonstrate that the premises, systems, facilities, equipment and responsible person meet the requirements. The Ministry of Health lists qualification and practical-experience categories; the government service page also requires a relevant examination to be passed by a director where applicable.

— GDP must be implemented.

— Licence holders are inspected at risk-based intervals.

— The licence is entered in the register of licensed wholesalers.

Manufacturing, repackaging, packaging or presentation, and importing medicines from third countries all require a manufacturing/import licence. The application should define the products, dosage forms, manufacturing and testing sites, and demonstrate capability. The licence is issued following an authorised inspection and a positive recommendation; regular GMP inspections follow once licensed. Preparation in a pharmacy by a pharmacist solely for retail supply, and professional operations for specific patients, are officially listed exceptions.

— At least one QP must be continuously available.

— The licence covers only the scope applied for.

— A wholesale licence cannot replace authorisation to import from third countries.

Pharmacists must be entered in the register of pharmacists. The official page lists qualifications, recognition of education, character, health, documentation and possible examination/practical requirements; those directly operating a pharmacy or supplying the public may be subject to additional Greek-language, practical or local internship requirements on a case-by-case basis. QPs must apply separately online and be entered in the QP register; the page lists relevant scientific qualifications, courses and standards for quality-related practical experience in a manufacturing company.

— Pharmacist registration is not pharmacy registration.

— QP registration is not a manufacturing licence.

— Qualifications of the person responsible for wholesale are verified on a case-by-case basis.

Pharmacies are subject to requirements for independent premises, building compliance and accessibility, and three inspections. Wholesale focuses on suitable premises, systems, facilities and equipment. Manufacturing focuses on premises, equipment, personnel, controls and storage capability that match the declared products, dosage forms, and manufacturing/testing sites. The website summary does not publish a uniform minimum floor area or complete engineering specifications for the sector.

— Pharmacy: independent premises and three inspections.

— Wholesale: facilities, equipment and GDP.

— Manufacturing: site, equipment and GMP.

Pharmacies submit pharmacist, premises, building and company information and undergo three inspections. Wholesale documentation includes the responsible person's CV, plans, responsibilities, equipment, and procedures for receipt, storage, inventory, recalls, returns, cleaning and maintenance. Manufacturing applications describe the products, sites and capabilities in the prescribed format and are decided following inspection. QPs apply online; national MAs are submitted through the common European submission portal using eCTD and signed documents.

— First align the company, personnel, premises, products and business scope.

— Use the respective forms; do not mix them.

— Operate only within the scope of written approval.

The official pharmacy service page states that there is no registration fee; the decision is communicated within three months of submission of a complete application, and registration is usually without time limit. The pharmacist registration fee is 100 euros, with a decision within three months of a complete application. The wholesale licence fee is 1,190 euros, the initial inspection fee is 102 euros, and the renewal fee is 683 euros; notification is given within three months of a complete application, and the licence is valid for five years. Manufacturing/third-country import is subject to prescribed review and inspection fees; a complete dossier is processed within 90 days at the latest, and the licence is valid for five years, but the page does not state current amounts.

— All the time periods above start from submission of a complete application.

— Reconfirm wholesale fee rates before submission.

— Confirm specific manufacturing fee rates with the competent authority.

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Pharmacies must keep records such as prescriptions, controlled drugs, purchases and receipts, supply medicines in accordance with prescriptions, and sell only products with an MA. Wholesale operations must maintain GDP and are subject to risk-based inspections; manufacturing must maintain GMP, ensure QP availability and undergo regular inspections. Wholesale and manufacturing licences are both renewed every five years. The product MA holder must report changes throughout the product lifecycle and apply for renewal and reassessment five years after approval.

— Pharmacy: records and lawful supply.

— Wholesale: GDP and renewal.

— Manufacturing: GMP, QP and renewal.

— Product MA: separate changes and renewal.

The Pharmacy Council approves pharmacy relocations, expansions and changes of ownership. The wholesale forms catalogue includes an application to vary a licence; manufacturing/third-country import also has a variation form, with review normally taking no more than 30 days and extendable to 90 days in special circumstances. The product MA holder must submit or notify changes to the product dossier. Changes to company registration do not replace pharmaceutical regulatory variations.

— Pharmacy: Relocation, expansion and changes of ownership require approval.

— Wholesale: Separate change procedure.

— Manufacturing: Separate change procedure.

— Products: MA changes are handled separately.

Product authorisation is available through national, mutual recognition／decentralised, centralised, special MA and parallel import routes. A national MA is valid only in the Republic of Cyprus and requires assessment of quality, safety and efficacy using a Greek- or English-language eCTD. Parallel import requires an MA in Cyprus and the source Member State, similarity, and a wholesale authorisation, and is permitted only from other Member States; the Drug Council assesses applications within 45 days. Imports from third countries require a manufacturing／import authorisation. Narcotic drugs, psychotropic substances and precursors are additionally controlled; specific permits apply to imports and exports, pharmacy／clinic purchases and stock inspections.

— A product MA is not an operating licence.

— Parallel import is not the same as import from a third country.

— Controlled-drug permits do not automatically form part of an operating licence.