Pharma License
Licensing for pharmaceutical manufacturing, wholesale distribution and pharmacy retail — plus the product-level approvals that sit alongside the business license.
Two Separate Approvals, Not One
Pharmaceutical activity in Albania — manufacturing, wholesale distribution, or running a retail pharmacy — is licensed at the business level by Albania’s National Agency of Medicines and Medical Devices, under the Ministry of Health. But holding that business license doesn’t itself authorise you to sell any given medicine: each individual product generally needs its own marketing authorisation before it can be distributed or sold, a separate, product-specific approval that runs alongside the business license rather than being covered by it. This two-layer structure is the detail most newcomers to the sector underestimate when planning a timeline.
Albania For Business Sh.p.k. supports pharmaceutical businesses through licensing — confirming the right category for your activity, preparing the business-level application, and coordinating the compliance requirements (GMP, GDP, responsible pharmacist) that come with it.
PHARMA LICENSE APPLICATION
fixed service fee
PACKAGE OF PHARMA LICENSE APPLICATION INCLUDES:
- Eligibility assessment for your specific pharma activity — manufacturing, wholesale, or retail pharmacy
- Determination of the correct license category and issuing authority
- Preparation of the license application and supporting documentation
- GMP/GDP compliance documentation, where applicable
- Responsible pharmacist / qualified person documentation
- Premises and storage compliance documentation
- Liaison with the National Agency of Medicines and Medical Devices throughout review
- Post-licensing compliance setup guidance
License Categories
| Category | Covers |
|---|---|
| Manufacturing | Producing pharmaceutical products — requires a manufacturing license under Good Manufacturing Practice (GMP) standards |
| Wholesale distribution | Importing or distributing medicines in bulk — requires a distribution license under Good Distribution Practice (GDP) standards |
| Retail pharmacy | Dispensing medicines to the public — requires a pharmacy license with a qualified responsible pharmacist |
Business License vs. Product Marketing Authorisation
Two separate approvals sit alongside each other in this sector. The business-level license (manufacturing, wholesale or pharmacy) authorises your company to operate in that role. Separately, each individual medicine you intend to sell or distribute generally needs its own marketing authorisation from the regulator, confirming that specific product is approved for sale in Albania. Holding a wholesale license doesn’t itself let you distribute any given product — the product needs its own approval too, and that process runs on its own timeline, in parallel with or ahead of your business license application.
What the Regulator Requires
- For manufacturing: GMP-compliant premises and quality management systems, plus a qualified person responsible for product release.
- For wholesale distribution: GDP-compliant storage and distribution practices, including appropriate storage conditions (cold chain, where relevant) and full traceability.
- For retail pharmacy: a qualified, licensed pharmacist as the responsible person, and premises meeting pharmacy-specific standards.
- Fit-and-proper directors and responsible persons across all categories.
- Product-level marketing authorisation for each specific medicine to be sold or distributed, obtained separately from the business license.
GMP/GDP standards, marketing authorisation procedures, pharmacist qualification requirements, and any pharmacy density or distance restrictions are set by current Albanian pharmaceutical regulation under the Ministry of Health and the National Agency of Medicines and Medical Devices, and should be verified before this page is published or relied upon for a specific application.
Retail Pharmacy Considerations
Many markets in the region regulate pharmacy density — minimum distances between pharmacies, or a cap tied to local population — to manage how many pharmacies can operate in a given area. Whether and how Albania applies similar restrictions should be confirmed for your specific intended location before committing to premises. A licensed, practicing pharmacist as the designated responsible person is a consistent requirement regardless of these locational rules.
Pharma Licensing, Step by Step
- Eligibility & category assessment — we confirm which license category applies and the correct issuing authority.
- Premises & personnel review — we confirm your premises and responsible pharmacist/qualified person meet requirements.
- Application & documentation prepared — the full application package is prepared to the regulator’s requirements.
- Filing with the National Agency of Medicines and Medical Devices — the application is formally submitted.
- Regulatory review & responses — we manage any information requests raised during review.
- License granted & compliance setup — once granted, we help set up ongoing reporting and, where needed, coordinate product-level marketing authorisation applications.
What We Need From You
- A description of your activity — manufacturing, wholesale distribution, or retail pharmacy.
- Details of your premises — manufacturing facility, storage/warehouse, or pharmacy location.
- Details of your responsible pharmacist or qualified person and their credentials.
- A list of products you intend to sell or distribute, if marketing authorisation is also needed.
- Details of your ownership and management structure.
Fee Schedule — Additional & Ongoing Services
Beyond the fixed package above, the following services are priced individually. Your adviser confirms an exact quotation once your structure, nationality and banking preference are known.
| Service | Indicative Fee |
|---|---|
| Pharma license application — retail pharmacy (as above) | From €800 fixed service fee |
| Wholesale distribution license (incl. GDP compliance) | from €1,500 |
| Manufacturing license (incl. GMP compliance) | from €3,000 |
| Product marketing authorisation (per product) | from €500 |
| Responsible pharmacist / qualified person documentation support | from €200 |
| Premises eligibility review (pharmacy location restrictions) | from €150 |
| License renewal support | from €300 |
The most common planning mistake in this sector isn’t the business license — it’s assuming that once you hold it, you can immediately distribute or sell any product you want. Marketing authorisation is granted per product, runs on its own timeline, and can take considerably longer than the business license itself. If your business plan depends on a specific product catalogue being available from day one, start the product-level approvals early and in parallel, not after the business license is granted.