Published: 24.09.2026. · GDP

Montenegro’s new Law on Medicines in 2026: what changes for wholesalers and GDP systems

Publisher: ConsultHQ

Montenegro adopted a new framework for medicines in 2026, amended the Law later in the year and updated CInMED’s GDP guidance and inspection procedures. Wholesalers now need to check their authorisations, responsible person, quality system, suppliers, transport, traceability, CAPA and evidence for GDP inspections against the current framework.

Good Distribution Practice did not become mandatory only in 2026. It was already part of the regulatory system. The change is that the new Law and its amendments are now accompanied by current CInMED guidance, standardised inspection documents, a CAPA procedure and updated forms for wholesale authorisations and GDP certificates.

The current framework is the Law in Official Gazettes 14/26 and 94/26

The new Law on Medicines was published in the Official Gazette of Montenegro 14/2026. CInMED lists the current Law as 14/26 and 94/26 and notes that it applies to procedures initiated from 17 February 2026.

The amendments were published in Official Gazette 94/2026 on 2 July and entered into force on 10 July 2026. CInMED says they were made at the European Commission’s request and to clarify provisions for more effective application.

A regulatory review must therefore use the Law together with its later amendments, rather than relying only on the original 14/26 text.

The new Law treats wholesale distribution of medicines as an activity of public interest

Wholesale distribution includes procuring, storing, supplying or exporting medicines, apart from dispensing directly to the public. Wholesale activity requires an appropriate authorisation specifying the premises covered.

CInMED grants wholesale authorisations for human medicines. It currently states that authorisations other than those involving medicines containing controlled drugs are issued for an indefinite period. That does not remove the need for continuous GDP compliance. A wholesale authorisation and a GDP certificate serve different regulatory purposes.

Wholesalers must operate under their authorisation and the GDP guidelines

Article 116 expressly requires a wholesaler to distribute medicines in accordance with its authorisation and GDP guidelines. Certain wholesale activities may be entrusted to another authorised wholesaler.

Transport is particularly important. A wholesaler may contract a legal or natural person that is not itself a wholesaler to transport medicines, provided that the carrier is registered for the activity and meets GDP requirements. Outsourcing does not remove the GDP issue: the wholesaler must be able to show that the contracted transport model and carrier match the products and distribution risks.

EU GDP Guidelines 2013/C 343/01 remain the European reference

A new national Law does not mean new EU GDP guidance. The European Commission continues to list 2013/C 343/01 as the guidance for good distribution practice of human medicines. It is based on Directive 2001/83/EC and aims to preserve medicine quality and integrity throughout distribution, including protection against falsified medicines.

CInMED published its current Guidelines on Good Distribution Practice for Medicinal Products for Human Use on 22 July 2026. Wholesalers should therefore read the Law, CInMED guidance and the applicable European GDP framework together.

The responsible person must be a pharmacist and continuously available

An applicant must demonstrate suitable premises, installations and equipment, a responsible person and other appropriate staff. The Law makes the person responsible for wholesale distribution accountable for implementing GDP guidance.

That person must have completed a pharmacy degree. The wholesaler must employ them full time and ensure their permanent and continuous availability. This is more than a formal appointment: the organisation must show that the responsible person has access to information and can participate in decisions affecting the GDP status of medicines.

A quality management system is a legal obligation for wholesalers

Article 119 requires the holder of a wholesale authorisation to maintain a quality management system defining responsibilities, procedures and risk-management measures for wholesale activities.

GDP is therefore more than a collection of SOPs. The system should connect responsibilities, documents, storage, transport, suppliers and customers, deviations, CAPA, complaints, returns, recalls, change control and self-inspections. Documentation is evidence of the system; it is not a substitute for one.

Suppliers and customers must be controlled

The Law also addresses partners in the distribution chain. Wholesalers should obtain medicines only from operators with the appropriate wholesale authorisation or from authorised manufacturers, and supply other authorised wholesalers or persons authorised to dispense medicines.

When buying from another wholesaler, the company must verify its GDP status, including its authorisation. When buying from a manufacturer or importer, it must verify the appropriate manufacturing authorisation. Supplier qualification is a demonstrable regulatory duty.

The framework strengthens protection against falsified medicines

Wholesalers must check that medicines received are not falsified, including verification of safety features where applicable. If a falsified medicine is offered or supplied, or falsification is suspected, they must promptly inform CInMED, the health inspectorate and, where relevant, the marketing authorisation holder.

These requirements should connect receiving procedures, supplier qualification and handling of suspect products. A visual check of packaging alone is not a complete system.

Wholesalers need an emergency recall plan

Article 119 requires an emergency plan for recalling medicines. It should support a recall ordered by CInMED or performed with the authorised manufacturer or marketing authorisation holder.

This depends on traceability. A wholesaler should be able to identify quickly which batch remains in stock, how much was distributed and to whom. A recall procedure has limited value if the necessary data cannot be retrieved promptly.

Distribution records must be available for five years

The Law requires records of medicines received, supplied or brokered. Records must include relevant details such as the date, medicine name, quantity, supplier or recipient and, where applicable, batch number. CInMED must be able to access them for five years.

Records can be paper or electronic. An ERP or warehouse management system can provide important GDP evidence if its data are reliable, accessible and connected to controlled processes.

Delivery documents must support distribution-chain traceability

The Law also specifies information accompanying deliveries. The document should make it possible to identify the delivery date, medicine name and pharmaceutical form, quantity, supplier and consignor, and at least for medicines with safety features, the batch number.

Wholesalers should check whether their documentation and information systems actually return the information needed for traceability, rather than judging only the appearance of an invoice or dispatch note.

CInMED issues the GDP certificate after an inspection

Article 126 provides the regulatory framework for GDP certification. CInMED, not ConsultHQ, assesses wholesale compliance with GDP guidelines through inspection and issues the GDP certificate when requirements are met. The procedure follows the EU Compilation of Union Procedures on Inspections and Exchange of Information.

Under the Law, CInMED issues a certificate within 90 days after the last inspection day when requirements have been met. A certificate is generally issued for up to five years. CInMED’s current page also describes issuance before wholesale activity begins and on a wholesaler’s request.

A GDP certificate may be suspended or withdrawn

The certificate is not a permanent assurance regardless of the system’s condition. If an inspection finds that requirements are not met, CInMED may suspend or withdraw the GDP certificate or issue a statement of non-compliance.

The Law also permits additional inspections after certification, including where medicine quality or safety is in doubt or an incident in distribution could affect the product. The GDP system must work every day, rather than being prepared only once every five years.

Inspection practice has moved closer to EU procedures

The Law envisages standardised forms for wholesale authorisations, GDP certificates, inspection reports and statements of non-compliance. The forms are based on EU and EMA instruments and are published by CInMED in Montenegrin and English.

On 19 August 2026, CInMED published documents from the Compilation of Union Procedures, including the GDP inspection procedure, issuance and updating of GDP certificates, and a GDP non-compliance statement. These documents show the direction of Montenegro’s inspection practice.

CAPA following a GDP inspection now has a standardised process

On 12 June 2026, CInMED published instructions for requesting a GDP certificate, instructions for submitting a CAPA plan after a GDP inspection and an agreed CAPA form.

CInMED asks wholesalers to submit post-inspection CAPA plans using the published form and instructions. The response should therefore follow the current regulatory process, not take the form of an arbitrary letter replying to an inspector’s findings.

Wholesale authorisation and GDP request forms were updated in September 2026

CInMED’s current page shows that its guidance and request form for obtaining, changing, supplementing or ending a wholesale authorisation were updated on 15 September 2026. The GDP certificate request form was also published on that date.

Before each new submission, a wholesaler should check the current version directly with CInMED. A form saved on a local server may be outdated.

Changes to authorised conditions require a regulatory response

When the conditions of a wholesale authorisation change, the Law requires the wholesaler to request an amendment or supplement from CInMED. The Institute decides on a complete application within 30 days, excluding periods spent waiting for additional documents.

GDP change control must therefore consider regulatory consequences. A change to premises, organisation or other particulars may also require an authorisation amendment before implementation.

EudraGMDP appears in the Law itself

The new Law provides for CInMED to enter information on wholesale authorisations into EudraGMDP, the European database covering GMP/GDP authorisations, certificates and regulatory information.

For Montenegrin companies, this reflects closer integration with European regulatory infrastructure and reinforces the need for reliable documents and evidence.

The new Law does not mean rebuilding an existing GDP system from scratch

An established wholesaler with a functioning GDP system does not need to replace every procedure automatically. It needs a regulatory gap analysis covering the responsible person, authorisations, quality system, suppliers and customers, transport, traceability, anti-counterfeit controls, recalls, CAPA, change control, inspection procedures and current CInMED forms.

Keep what already meets the requirements. Change what the current framework and regulatory practice show to be deficient.

What wholesalers should check now

A focused review after the 2026 changes should ask:

• Is the company using the Law as published in 14/26 and 94/26?
• Does its authorisation match current operations, and does the responsible person meet legal conditions?
• Does the quality system follow current GDP guidelines?
• Are suppliers, customers and outside carriers appropriately qualified and controlled?
• Can batch and customer data be retrieved quickly, and is the recall plan workable?
• Are CAPA, change control and CInMED forms current?
• When was the last internal GDP check, and are open findings demonstrably closed?

This is more useful than simply changing dates on SOPs.

ConsultHQ can connect the new Law to an existing GDP system

Wholesalers need legal requirements to work within daily operations, not another regulatory binder. Through a GDP gap analysis, ConsultHQ can review documents and processes against the Law on Medicines as published in 14/26 and 94/26, current CInMED GDP guidelines and the European GDP framework.

Where gaps exist, we can help update SOPs, CAPA, change control and training, and carry out an internal review before the next CInMED inspection. CInMED conducts the independent inspection and decides whether to issue a GDP certificate. Our role is to help the wholesaler demonstrate in daily work that medicine quality and integrity remain controlled throughout distribution.

ConsultHQ’s role: We help prepare the GDP system, documents, training and internal reviews. CInMED independently inspects and decides whether to issue a GDP certificate; ConsultHQ does not issue certificates or conduct certification audits.

Related services: GDP implementation, GDP for wholesalers and medicine transport and storage.

Official sources: CInMED: Law on Medicines 14/26 and 94/26; Official Gazette: Law 14/2026; Official Gazette: amendments 94/2026; CInMED: GDP guidelines and inspection procedures; CInMED: forms and CAPA procedure.

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