Last updated on November 9, 2025
No. Albanian law strictly prohibits the sale of pharmaceuticals without prior authorization from the National Agency for Medicines and Medical Devices (AKBPM). Marketing authorization is mandatory to ensure safety, quality, and efficacy before any medicine reaches the market.
The Legal Backbone of Pharmaceutical Control
In Albania, medicines are not treated as ordinary goods—they are regulated under a robust legal framework designed to protect public health. The cornerstone of this system is Law No. 105/2014 “On Medicines and Pharmaceutical Service”, which sets out the rules for production, import, export, and marketing of drugs intended for human use. According to this law, no pharmaceutical product can be placed on the market without a valid marketing authorization issued by the National Agency for Medicines and Medical Devices (Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore).
This requirement aligns Albania with European Union standards, particularly Directive 2001/83/EC, ensuring that medicines meet rigorous criteria for safety, quality, and efficacy. The authorization process involves scientific evaluation, inspection, and compliance checks, making it a critical barrier against counterfeit or substandard drugs.
Why Approval Is Non-Negotiable
Medicines affect lives directly, and any compromise in quality can have severe consequences. By mandating prior approval, Albania aims to prevent health risks, protect consumers, and maintain trust in its healthcare system. The law also covers pharmacovigilance, advertising, and quality control, creating a comprehensive safety net around pharmaceutical activities.
Selling drugs without authorization is not just a regulatory breach—it is a criminal offense. Penalties include fines, license revocation, and even imprisonment for severe violations. These measures underscore the government’s zero-tolerance stance on unauthorized pharmaceutical trade.
Cultural and Historical Context
Albania’s pharmaceutical regulation has evolved significantly over the past decade. Before 2014, fragmented rules allowed loopholes that sometimes led to market abuses. The adoption of Law No. 105/2014 marked a turning point, introducing EU-aligned standards and strengthening institutional oversight. Today, the AKBPM operates as the central authority for drug control, supported by the Ministry of Health and Social Protection.
This modernization reflects Albania’s broader healthcare reforms aimed at improving access, affordability, and safety. It also positions the country for deeper integration with European health systems, where strict compliance is the norm.
Practical Steps for Compliance
For manufacturers, importers, and distributors, the path to legality is clear:
- Apply for marketing authorization with the AKBPM, submitting a complete dossier on the product’s composition, manufacturing process, and clinical data.
- Obtain licenses for wholesale or retail activities, as required by the National Licensing Center.
- Ensure ongoing compliance with pharmacovigilance and quality standards throughout the product’s lifecycle.
Skipping these steps is not an option. Even humanitarian aid involving medicines requires special permits, reinforcing the principle that every drug entering Albania must be traceable and approved.
What Happens If You Ignore the Rules?
Non-compliance triggers swift enforcement. Authorities can seize unauthorized products, impose heavy fines, and initiate criminal proceedings. Repeat offenders risk permanent exclusion from the pharmaceutical market. These sanctions serve as a deterrent and a reminder that public health is non-negotiable.
The Bigger Picture: Trust and Transparency
Pharmaceutical regulation is more than bureaucracy—it is a public health safeguard. By enforcing strict approval requirements, Albania ensures that patients receive medicines they can trust. This transparency strengthens the healthcare system and aligns the country with international best practices.
The Bottom Line
Selling pharmaceuticals in Albania without approval from the National Agency for Medicines is strictly prohibited. The law prioritizes safety, accountability, and compliance, making authorization the gateway to a legal and ethical pharmaceutical market.
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Sources
Ligj Nr.105/2014 “Për barnat dhe shërbimin farmaceutik” – Ministria e Shëndetësisë
https://qbz.gov.al/share/law/105-2014
Ongoing
Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore – Ministria e Shëndetësisë
https://akbpm.gov.al/
Ongoing