New Zealand Pharmaceutical Licensing

This guide discusses only the business pathways for pharmaceutical retail, wholesale and manufacturing in New Zealand. Nationwide section 17 of the Medicines Act 1981 provides that manufacturing, wholesaling or packing/labeling medicines in the course of business, or operating a pharmacy, generally requires the corresponding licence under Part 3; this is not a system combining local state or provincial licences.

At applicant level, a statutory licence application may be made by an individual resident in New Zealand, or submitted on behalf of a company incorporated in New Zealand by an appropriate person. A product sponsor must be a manufacturer, importer or owner resident in New Zealand; an overseas company may use a New Zealand subsidiary or local agent as sponsor. These rules do not mean that all foreign investment or shareholding structures are permitted or prohibited, particularly because pharmacies have separate ownership rules.

— First distinguish four matters: business/site licences, product marketing consent, individual pharmacist practising qualifications, and specialist controlled-drug licences.

— Before investing or establishing a site, check whether the intended activities are pharmacy operation, non-pharmacy retail, wholesale, manufacturing, packaging/labelling or a combination.

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Medsafe is the New Zealand medicines and medical devices safety regulator within the Ministry of Health. It is responsible for most matters under the Medicines Act, including approval of new medicines and changes, manufacturer audits and licensing, pharmacy and wholesaler audits and licensing, and medicine supply-chain and border controls. Pharmacy licences are issued by the Medsafe Licensing Authority.

The main statutes are the Medicines Act 1981 and Medicines Regulations 1984. If a product is a controlled drug, it is also governed by the Misuse of Drugs Act 1975. Controlled-drug legislation is an additional legal layer, not an ancillary provision of a general pharmacy or wholesale licence.

— Medsafe: medicine business licensing, product consents, GMP, medicine supply-chain and safety regulation.

— Pharmacy Council: individual pharmacist registration and Annual Practising Certificate.

— Medicines Control: application interface for matters such as pharmacy licences and commercial import and export of controlled drugs.

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New Zealand distinguishes between a Licence to Operate a Pharmacy and a Licence to Sell Medicines by Retail. The former authorises a pharmacy to be established at a specified location and to provide pharmacy services; no pharmacy may open to the public without a licence and the immediate supervision and control of a pharmacist.

The latter is a separate retail medicine sales licence and does not authorise retail sale of prescription or restricted medicines. Retail channels for prescription medicines, restricted medicines and pharmacy-only medicines are separately restricted under section 18 of the Medicines Act; an ordinary retail licence should not be treated as covering pharmacy operations or retail sale of prescription medicines.

— A pharmacy licence application must disclose the entity, street address, scope of the pharmacy, person in charge and interests in the pharmacy.

— An ordinary retail licence application must specify the medicines and place of sale; the prescribed form also requires a declaration that the premises are more than 10 kilometres from the nearest pharmacy and an explanation of the reason.

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A Licence to Sell Medicines by Wholesale is required to sell medicines wholesale in the course of business. The licence is limited to the medicines stated on it and generally does not authorise operations at premises other than those specified on the licence. A wholesale licence is a business authorisation; it does not mean that a particular new medicine has been consented for distribution in New Zealand.

For a sponsor proposing to sell a new medicine, Medsafe guidance states that it should have a legal presence in New Zealand and hold a wholesale licence as the seller. The sponsor is also responsible for batch documentation, complaint and recall procedures, stock traceability, supplier arrangements and ultimate product responsibility for the New Zealand market.

— The application should specify the medicines or categories proposed for wholesale, the premises for sale, the qualifications of the person in charge, and include the prescribed fee.

— Supply of an unapproved medicine generally also requires a wholesale licence, as well as retention of imported batch specifications, certificates of analysis and supply information, and monthly reporting.

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Medicine manufacture requires a Licence to Manufacture Medicines; separate packing or labelling activities may also require a Licence to Pack Medicines. A manufacturing licence may, by law, authorise the manufacture, packing, labelling and wholesale of the medicines specified in it, but should not be interpreted as granting every product or cross-border authorisation.

Medsafe requires evidence of GMP compliance for finished-product manufacturing/packing and other sites. A manufacturing or packing site in New Zealand must hold a current licence covering that site and type of operation before beginning manufacture or packing for distribution. For an overseas site, current GMP evidence must accompany an application or notification for a new medicine or a change to a manufacturing site.

— A manufacturing application must specify the category of medicines; the licensing authority will issue a licence only for medicines/categories that it considers the applicant qualified and capable of manufacturing.

— Acceptable GMP documentation should generally correspond to the actual site, product/category, GMP acceptance or audit, issuing authority and validity. Where overseas evidence is insufficient, an audit by Medsafe may be requested, at the applicant's expense.

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The pharmacy's Responsible Person is usually a pharmacist-owner; if a company is jointly owned by several pharmacists who hold a majority of its share capital and effectively control it, all those pharmacists should be appointed as Responsible Persons. A Responsible Person must have adequate knowledge of licensed duties and medicine hazards, have no APC condition that prevents them from performing their duties, and be responsible for day-to-day operations, quality risks, records, site security and staff supervision.

Individual pharmacist practice qualifications are administered by the Pharmacy Council. Only a person who is registered and holds a current practising certificate is qualified to practise; registration without a practising certificate does not authorise practice. This individual qualification is a separate compliance track from pharmacy, wholesale or manufacturing business licences. For wholesale or manufacturing, the regulations require disclosure of the qualifications of the applicant or the company's person in charge and allow knowledge to be assessed case by case; no uniform education or staffing-number standard has been invented in this guide.

— The pharmacy's Responsible Person must periodically review whether they continue to meet the requirements and immediately notify the Licensing Authority if a new condition is added to their APC that affects their ability to perform their duties.

— A pharmacy operator must not require an employed pharmacist to act contrary to professional or ethical standards.

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Licences are closely tied to premises. The Medicines Act provides that, unless the licence or regulations permit otherwise, a licence does not authorise the manufacture, packing, labelling or sale of medicines at premises other than those specified or described in the licence. Regulation 45 requires applications to specify the proposed premises; generally, one licence corresponds to one business location.

A pharmacy application must provide a street address and define which part of the address constitutes the pharmacy, or attach a plan. Although a manufacturing application may cover multiple sites where the legal entity can demonstrate that each is appropriately supervised, this is not an automatic entitlement. The licensing authority may require inspection of the applicant's premises and equipment; domestic manufacturing/packing sites must also ensure that actual operations match the licence scope and GMP evidence.

— Pharmacy: address, pharmacy boundaries, medicine security, equipment and arrangements for keeping records.

— Wholesale: premises from which medicines are sold, and storage/record arrangements consistent with the scope stated on the licence.

— Manufacture/packing: actual operational site, product categories, GMP evidence and possible site inspection.

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All applications for operating licences must be submitted on the prescribed form, accompanied by the prescribed fee, and specify the description/category of medicines applied for. Applications for manufacture, wholesale, retail or packaging must also state the premises; if the applicant is a company, it must specify the qualifications of the person who will be responsible for the licence. Medsafe may, under its statutory powers, request further information and inspect premises and equipment.

Pharmacy applications have a dedicated form and require more extensive disclosure: the entity, company directors or information about related entities, the responsible person, street address and scope of the pharmacy, interests in the pharmacy, and the applicant's eligibility to obtain a licence. Medsafe's public pharmacy register is published by legal entity and street address, also reflecting that the licence is not registered by brand alone.

— After confirming the activity and medicine classification, select the correct licence application form and proposed applicant entity.

— Prepare information on the applicant's eligibility, the responsible person's qualifications, premises, medicines/categories, required declarations and fees.

— Allow time for requests for further information and premises inspections; however, public information does not provide a uniform processing time for all cases.

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The fee schedule revised by Medsafe on 6/7/2026 lists NZ$14,328 for a Licence to Manufacture Medicines, NZ$1,123 for a Licence to Sell Medicines by Wholesale, NZ$900 for a Licence to Sell Medicines by Retail, and NZ$1,097 for a Licence to Operate Pharmacy; all listed fees include GST. Specific changes, audits, product applications or controlled-drug matters may incur additional fees.

Section 53 of the Medicines Act provides that, except in circumstances such as early cancellation, a licence generally remains in force for one year. If an application for a new licence is made to bridge the transition from an old licence, at least one month and no more than three months before the old licence expires, and the application has not yet been determined, the old licence may continue in force under that section until the application is determined. No official uniform approval timeframe applicable to all cases was found; therefore, a fixed completion date should not be promised.

— Assess licence fees, product consent fees, GMP/audit fees and controlled-drug licence fees separately.

— Recheck the latest fee schedule and form version before submission; public pages are updated.

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Ongoing compliance begins with ensuring that the licence does not expire, that its stated scope matches actual activities, and that the current licence is prominently displayed at the relevant premises. Manufacturing/packaging sites must also maintain the applicable GMP compliance. Medsafe guidance requires sponsors to continue submitting current GMP evidence for each relevant site to ensure that consented products continue to meet requirements.

The pharmacy's responsible person must ensure the ongoing fulfilment of licence conditions, medicine and premises security, suitable equipment, staff supervision, a quality risk-management system and medicine records, and continued compliance with the pharmacy quality audit framework. The sponsor should also maintain arrangements for complaints/recalls, batch release and traceability, supplier audits, and reporting significant product issues to Medsafe.

— Renewal: monitor the one-year term and prepare a bridging application within the statutory window.

— Manufacturing: maintain a current licence and GMP evidence for every actual manufacturing/packaging site.

— Pharmacy: ensure the responsible person, APC status, records, equipment, security, staff supervision and quality audits remain current.

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When a pharmacy's responsible person changes, an application to amend the pharmacy licence must be made to Medsafe; any change to the information in a licence application, including a change of responsible person, must be notified to Medsafe as soon as possible. If a change in shareholding means that pharmacists no longer hold more than 50% of the share capital of a company pharmacy, Medsafe must be notified immediately.

A share transaction should include particular scrutiny of pharmacy eligibility: a company must generally continue to have more than 50% of its share capital held by pharmacists and remain under their effective control; an individual obtaining a pharmacy licence or majority interest also generally must be a pharmacist, subject to separate verification of exceptions such as hospitals and statutory exemptions. As licences are issued to an applicant for specified activities and premises, a share sale, name change, replacement of the responsible person or relocation must not be treated as automatically transferring the licence. Changes to product manufacturing sites, formulations, names and other details may also require product procedures such as a CMN/NMA.

— Before a pharmacy transaction: check each interest holder, pharmacist majority ownership, effective control, responsible person and target address.

— Change of responsible person: the application to amend the licence must be made by a pharmacist with effective control or by the existing responsible person.

— Product changes: also check the Changed Medicine Notification, GMP documents and product sponsor information; do not only amend company details.

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A business operating licence does not mean that a medicine may be marketed in New Zealand. In most cases, a new medicine or relevant product must first receive the Minister's consent; the application is submitted to Medsafe and supported by quality, safety, efficacy and risk-benefit information. Significant changes to an approved product are also subject to product-change restrictions and may need to be addressed through a CMN or another application.

A New Zealand sponsor must assume product responsibilities for an overseas company entering the market. An unapproved medicine may be supplied under statutory exceptions and the section 29/29A pathways, but this generally requires a licensed wholesaler or pharmacy to act as the importer/supplier, and batch specifications, certificates of analysis and patient supply information must be retained, with monthly notifications made. Commercial import or export of controlled drugs requires a separate licence issued by Medicines Control; the manufacture of controlled drugs is also restricted under the Misuse of Drugs Act.

— Product marketing: Ministerial consent for a new medicine/relevant product is applied for separately from a business licence.

— Local sponsor: a New Zealand-resident manufacturer, importer, owner or local agent assumes responsibility for recalls, information and the supply chain.

— Controlled drugs: verify commercial import/export licences separately from ordinary medicine wholesale/manufacturing licences; medicinal cannabis and other matters may have separate requirements.

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