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Pharma Licence in Romania

Community pharmacy · wholesale distribution · ANMDM · GDP · pharmacist requirement

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Pharmaceutical activities in Romania — whether operating a community pharmacy, distributing medicines wholesale or importing medicinal products — require a licence or authorisation from ANMDM (Agenția Națională a Medicamentului și a Dispozitivelor Medicale), the Romanian national medicines agency. ANMDM is the competent authority designated under EU pharmaceutical law to issue marketing authorisations, manufacturing licences, wholesale distribution authorisations and community pharmacy licences in Romania.

Romania For Business SRL assists pharmaceutical companies, independent pharmacists, wholesale distributors and importers in obtaining the correct ANMDM authorisation. We coordinate the eligibility assessment, premises compliance review, GDP/GPP programme preparation, Responsible Pharmacist identification and the complete ANMDM application process. All services are delivered in English.

Operating pharmaceutical activities without an ANMDM licence is a criminal offence in Romania

Selling, distributing or dispensing medicinal products without a valid ANMDM authorisation is a criminal offence under Romanian pharmaceutical law. ANMDM conducts regular inspections of pharmacies and distribution companies — unlicensed operators face immediate closure, product seizure and criminal prosecution. The ANMDM licence must be in place before any pharmaceutical activity begins.

Types of Pharmaceutical Licence in Romania

ANMDM issues different types of authorisation depending on the pharmaceutical activity. The main licence types relevant to international clients are:

Community Pharmacy
farmacie comunitară

  • Retail dispensing to the public
  • Prescription (Rx) medicines
  • OTC medicines and health products
  • Pharmacist-in-charge required
  • ANMDM + DSP authorisation

Wholesale Distribution
distribuție en-gros medicamente

  • Supply to pharmacies, hospitals, clinics
  • GDP (Good Distribution Practice) required
  • Qualified Person for distribution
  • Temperature-controlled warehousing
  • ANMDM GDP authorisation

Pharmaceutical Import
import produse farmaceutice

  • Import from non-EU third countries
  • Qualified Person (QP) for release
  • Batch testing requirements
  • Customs and ANMDM authorisation
  • GMP compliance at source

Manufacturing
fabricare medicamente

  • GMP (Good Manufacturing Practice)
  • Manufacturing authorisation (MA)
  • Qualified Person (QP) required
  • ANMDM GMP inspection
  • EU GMP certificate issued

This page focuses on the two most commonly requested licence types for international clients: the community pharmacy licence and the wholesale distribution authorisation. For pharmaceutical manufacturing and import, contact us for a dedicated eligibility assessment.

Community Pharmacy Licence (Farmacie Comunitară)

A community pharmacy (farmacie comunitară) is authorised to dispense prescription and over-the-counter medicinal products to the public. The licence is issued jointly by ANMDM (which assesses the professional and quality standards) and the local DSP (Direcția de Sănătate Publică — County Health Directorate, which inspects the premises).

Responsible Pharmacist (Farmacist Șef) — The Critical Requirement

Every Romanian community pharmacy must have a Responsible Pharmacist (farmacist șef) — there is no exception

Romanian law requires every community pharmacy to have a designated Responsible Pharmacist (farmacist-șef) — a qualified pharmacist holding a Romanian pharmacy degree (or an EU-recognised equivalent) and registered with the Romanian College of Pharmacists (Colegiul Farmaciștilor din România). The Responsible Pharmacist must be present in the pharmacy during all dispensing hours. A company cannot open a pharmacy without securing a qualified pharmacist first — this is the primary constraint for international investors.

Community pharmacy requirement Detail
Responsible Pharmacist (farmacist-șef) A qualified pharmacist with a Romanian or EU-recognised pharmacy degree, registered with the Colegiul Farmaciștilor din România. Must be the licence holder or formally appointed as the responsible person. The pharmacist must be physically present during all pharmacy operating hours — they cannot manage the pharmacy remotely.
Premises location and size The pharmacy must be located in a building with a dedicated, separate entrance and a minimum usable floor area — typically 35–50 m² depending on the local authority and ANMDM requirements. The premises must not be inside a general commercial space without clear separation.
Premises layout requirements The pharmacy must include: a public dispensing area, a back-office preparation/storage area, separate storage for controlled substances (narcotics) with secure locked cabinet, a temperature-controlled medicine storage zone and a restroom. ANMDM and DSP provide detailed technical specifications.
Temperature-controlled storage All medicinal products requiring cold-chain storage (typically 2–8°C for refrigerated medicines) must have a certified pharmaceutical-grade refrigerator or cold room. Temperature must be monitored and logged continuously. Evidence of temperature monitoring is required for ANMDM authorisation.
IT dispensing system Community pharmacies must use an approved pharmaceutical IT system for recording dispensing, managing stock and generating receipts. The system must integrate with the CNAS (National Health Insurance House) for the reimbursement of prescription medicines.
Controlled substances licence Pharmacies dispensing narcotic and psychotropic medicines (substances under international control) require a separate authorisation from ANMDM for handling controlled substances. This is typically included as part of the pharmacy licence application.
DSP premises inspection Before ANMDM issues the pharmacy licence, the DSP (County Health Directorate) of the county where the pharmacy is located conducts a physical premises inspection — confirming that the layout, equipment and storage conditions meet the requirements.
ANMDM licence fee ANMDM charges application and annual licence fees — confirmed on the ANMDM website and updated periodically. Confirm current fees before proceeding.

Wholesale Pharmaceutical Distribution Licence (GDP Authorisation)

A wholesale distribution authorisation from ANMDM allows a company to supply medicinal products to pharmacies, hospitals, clinics, other distributors and exporters — in compliance with EU Good Distribution Practice (GDP) guidelines. GDP compliance is mandatory under EU Directive 2001/83/EC and the EU GDP Guidelines (2013/C 343/01).

GDP wholesale requirement Detail
Qualified Person for Distribution (QPD) The wholesale distributor must designate a Qualified Person Responsible for Distribution (Persoana Calificată Responsabilă cu Distribuția) — a named individual approved by ANMDM. The QPD must have a relevant educational background and experience in pharmaceutical supply chain management.
GDP-compliant premises The distribution warehouse must comply with EU GDP guidelines — including: adequate storage space, temperature mapping and control, pest control, appropriate security, separate areas for quarantine and returned goods, and documented cleaning procedures.
Temperature-controlled logistics Cold-chain products (2–8°C) and ultra-cold products must be stored and transported with validated temperature control. All vehicles and storage units used for pharmaceutical transport must have temperature monitoring and logging equipment.
Sourcing — authorised suppliers only GDP requires that medicinal products are sourced only from authorised manufacturers, marketing authorisation holders or other authorised wholesale distributors. All supply chain partners must be verified — ANMDM maintains a register of authorised suppliers and distributors.
Quality Management System (QMS) A documented Quality Management System covering: SOPs for all distribution activities, change control, deviations and CAPA procedures, product recall capability, complaint management and self-inspection programme. The QMS must be in place and operational before the ANMDM inspection.
ANMDM GDP inspection Before issuing the wholesale distribution authorisation, ANMDM conducts a GDP inspection of the premises and management systems. The inspection assesses compliance with the EU GDP Guidelines in detail. Any deficiencies identified must be corrected before the authorisation is issued.
Falsified medicines prevention EU Directive 2011/62/EU (Falsified Medicines Directive) requires wholesale distributors to implement the European Medicines Verification System (EMVS / FMD) — serialisation and verification of prescription medicines at the point of supply. Compliance must be evidenced as part of the GDP application.

Pharma Licence Application Process — Step by Step

The ANMDM licensing process for both community pharmacies and wholesale distributors follows a structured dossier submission and inspection process. Romania For Business SRL coordinates the complete process in English.

01

Licence type & eligibility confirmed

02

Responsible Pharmacist / QPD identified

03

Premises secured & fitted out

04

GDP/GPP programme drafted

05

ANMDM dossier prepared

06

DSP inspection (pharmacy)

07

ANMDM submission & review

08

Authorisation granted

Stage What happens
1. Eligibility and licence type We confirm the correct ANMDM licence type, the applicable legal framework and the specific requirements — including qualification of the Responsible Pharmacist or QPD, premises minimum standards and GDP/GPP documentation requirements.
2. Responsible Pharmacist / QPD For pharmacy licences: we assist in identifying a qualified pharmacist (farmacist-șef) registered with the Colegiul Farmaciștilor. For wholesale licences: we assess the QPD candidate’s qualifications and coordinate their ANMDM approval. This step must be started before the premises are finalised — the pharmacist or QPD must be confirmed before the application is submitted.
3. Premises preparation We advise on premises selection — confirming minimum area requirements, location rules (distance from other pharmacies in some localities), layout specifications and equipment requirements. Premises must be fitted out and operational before the DSP or ANMDM inspection.
4. GDP/GPP programme We prepare the GDP or GPP quality documentation — Quality Management System, SOPs, quality manual, temperature monitoring records, supplier qualification procedures and recall procedures. The programme must be implemented, not just drafted, before the inspection.
5. ANMDM dossier preparation We prepare the complete ANMDM application dossier — application forms, premises plans, equipment certificates, staff qualification documents, GDP/GPP programme index and all ANMDM-specified annexes.
6. DSP inspection (pharmacy) For community pharmacies: the DSP conducts a physical premises inspection before ANMDM issues the licence. We coordinate the DSP inspection appointment and prepare the pharmacy director for the inspection visit.
7. ANMDM review and queries ANMDM reviews the dossier and may request additional information. We manage all ANMDM correspondence — responding promptly to information requests to keep the review moving.
8. Authorisation and compliance ANMDM issues the authorisation. We brief the client on all ongoing GDP/GPP obligations — periodic ANMDM inspections, annual self-inspections, deviation reporting, recall procedures and licence renewal.

GDP and GPP — Ongoing Compliance Obligations

An ANMDM pharmaceutical licence is not a one-time approval — it creates ongoing Good Distribution Practice (GDP) or Good Pharmacy Practice (GPP) obligations that must be maintained for the life of the licence. ANMDM conducts periodic unannounced inspections of licensed premises.

Ongoing obligation What it means in practice
Periodic ANMDM inspections ANMDM conducts routine and unannounced GDP/GPP inspections of pharmacies and wholesale distributors. Inspection findings are classified by severity — critical, major and other deficiencies. Critical deficiencies can result in immediate licence suspension.
Annual self-inspection Licensed pharmacies and distributors must conduct an annual internal self-inspection of their GDP/GPP compliance — documenting findings, identifying deficiencies and implementing corrective actions. Self-inspection records must be available for ANMDM review.
Temperature monitoring continuity Temperature monitoring equipment must be maintained, calibrated and continuously operational. Temperature deviations must be investigated and documented. Failure to maintain continuous temperature monitoring records is a GDP deficiency.
Product recall capability The licensee must maintain a documented and tested product recall procedure — capable of rapidly identifying and withdrawing any defective or falsified medicine from the supply chain. ANMDM may conduct mock recalls as part of inspections.
ANMDM change notifications Any significant change to the licensed premises, the Responsible Pharmacist / QPD, the ownership of the company or the scope of licensed activities must be notified to ANMDM and, where required, approved before implementation.
Annual licence renewal ANMDM licences must be renewed periodically — the renewal interval depends on the licence type. Renewal requires confirmation that all conditions continue to be met and payment of the applicable ANMDM renewal fee.
A GDP/GPP inspection deficiency notice does not mean immediate closure — but it requires a prompt corrective action plan

ANMDM inspections typically result in a deficiency classification report. Minor deficiencies require a corrective action plan within 30 days. Major deficiencies require a corrective action plan within 15 days and may result in suspension of specific activities until corrected. Critical deficiencies result in immediate licence suspension. Romania For Business SRL supports clients through ANMDM inspection preparation and corrective action planning.

PHARMA LICENCE — ROMANIA (ANMDM)

from €2,000
engagement fee

PHARMA LICENSING ENGAGEMENT INCLUDES:

  • Licence type assessment — community pharmacy, wholesale distribution or import
  • ANMDM eligibility review — premises, qualified person and GDP/GPP requirements
  • Responsible Pharmacist identification and registration coordination
  • Premises compliance assessment — layout, storage, temperature control, security
  • GDP programme preparation — for wholesale distribution applicants
  • GPP quality system documentation — for community pharmacy applicants
  • ANMDM application preparation — all forms, technical documentation and dossier
  • DSP (County Health Directorate) coordination — pharmacy premises inspection
  • ANMDM submission and correspondence throughout the review period
  • Qualified Person (QP) documentation — for import and manufacturing activities
  • Licence condition compliance briefing — GDP/GPP ongoing obligations and renewal

INDICATIVE ENGAGEMENT FEES

  • Community pharmacy licence (ANMDM + DSP) — new premises from €2,000
  • Wholesale pharma distribution licence (ANMDM GDP) from €2,500
  • Pharmaceutical import authorisation (ANMDM) from €2,000
  • GDP programme documentation (wholesale distribution) from €1,200
  • GPP quality system documentation (community pharmacy) from €800
  • Annual pharmacy licence renewal coordination from €600/yr
  • ANMDM regulatory authority fees billed at cost

Fees confirmed in writing after eligibility assessment. ANMDM regulatory fees and DSP inspection fees are billed at cost separately. Pharma licensing is a highly technical and document-intensive process — timeline and cost depend on the licence type and the applicant’s existing GDP/GPP infrastructure. Fees may be subject to Romanian VAT.

Frequently Asked Questions — Pharma Licence in Romania

ANMDM (Agenția Națională a Medicamentului și a Dispozitivelor Medicale) is the Romanian National Agency for Medicines and Medical Devices — the competent authority responsible for issuing pharmaceutical licences, supervising the pharmaceutical market and enforcing Romanian pharmaceutical law and EU pharmaceutical directives. ANMDM issues community pharmacy licences, wholesale distribution authorisations, manufacturing licences and import authorisations for medicinal products and medical devices.

Yes — this is the most important requirement and the most common barrier for international investors. Every community pharmacy in Romania must have a designated Responsible Pharmacist (farmacist-șef) — a qualified pharmacist holding a Romanian pharmacy degree (or an EU-recognised equivalent) and registered with the Romanian College of Pharmacists (Colegiul Farmaciștilor din România). The pharmacist must be physically present during all dispensing hours. A company cannot hold a pharmacy licence without a named, qualified and registered pharmacist on record with ANMDM.

Yes — but the foreign pharmacist’s qualifications must be recognised in Romania. EU pharmacists can have their qualifications automatically recognised under EU Directive 2005/36/EC on professional qualifications, subject to completing the recognition procedure with the Colegiul Farmaciștilor din România. Pharmacists from non-EU countries must go through a longer qualification recognition procedure. Romania For Business SRL advises on the qualification recognition process for foreign pharmacists.

Good Distribution Practice (GDP) is the EU standard for the wholesale distribution of medicinal products — ensuring that medicines are consistently stored, transported and handled under appropriate conditions throughout the supply chain. GDP compliance is mandatory under EU Directive 2001/83/EC and the EU GDP Guidelines (2013/C 343/01), implemented in Romania by ANMDM. A company cannot obtain a wholesale distribution authorisation from ANMDM without demonstrating a GDP-compliant quality management system and premises.

The community pharmacy licence process typically takes 4–9 months from starting the premises fit-out to receiving the ANMDM authorisation. The main time drivers are: premises fit-out (typically 2–4 months), DSP inspection scheduling (2–6 weeks from application), ANMDM dossier review (4–8 weeks). The wholesale distribution authorisation process is typically 6–12 months — the GDP programme preparation and ANMDM inspection are the main time drivers. Starting the pharmacist / QPD identification early is essential — it cannot be done at the last minute.

Yes. Romanian law allows non-pharmacists to own the company that operates a pharmacy — the company can be owned by any Romanian or foreign individual or corporate entity. However, the licence itself is granted subject to the company employing or contracting a qualified Responsible Pharmacist (farmacist-șef) who is registered with the Colegiul Farmaciștilor and named on the ANMDM licence. The owner cannot substitute for the pharmacist requirement.

ANMDM and DSP require community pharmacies to have a minimum usable floor area — typically 35–50 m² depending on the ANMDM technical norms and local conditions. The space must include a public dispensing area, storage areas (including cold-chain storage), a separate area for narcotics/controlled substances, and a restroom. ANMDM’s technical norms provide detailed layout specifications — we advise on these requirements before the premises are selected or fitted out.

A Romanian ANMDM wholesale distribution authorisation covers distribution activities within Romania and cross-border supplies from Romania. For EU-wide distribution, the company needs either: (a) a Romanian licence that covers cross-border supply to specific EU countries (subject to compliance with the importing country’s rules), or (b) separate wholesale distribution authorisations in each EU country it supplies. EU pharmaceutical law does not provide automatic passporting for wholesale distribution licences — each member state has its own licensing regime. Romania For Business SRL advises on the correct approach for cross-border distribution.

ANMDM conducts both routine and unannounced GDP/GPP inspections of licensed pharmacies and wholesale distributors. Routine inspections for pharmacies typically occur every 1–3 years. Wholesale distributors are inspected more frequently — typically annually or bi-annually. Inspections can also be triggered by complaints or reported deviations. Inspection findings are classified by severity — critical deficiencies result in immediate suspension; major deficiencies require corrective action within 15 days; minor deficiencies within 30 days.