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Pharma Licence in Romania

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

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Pharmaceutical activities in Romania require different authorisations depending on the activity. Community pharmacies are authorised by the Romanian Ministry of Health, while wholesale distribution, manufacturing and import activities fall within ANMDMR competence. Romania’s pharmaceutical regulatory framework is based on EU pharmaceutical law and national legislation.

ANMDMR is the competent authority for marketing authorisations, manufacturing/import authorisations and wholesale distribution authorisations for medicinal products. Community pharmacy operating authorisations are issued by the Romanian Ministry of Health. Romania for Business Advisory S.R.L. assists pharmaceutical companies, independent pharmacists, wholesale distributors and importers in obtaining the correct authorisation. We coordinate the eligibility assessment, premises compliance review, GDP/GPP programme preparation, Responsible Pharmacist identification and the complete application process. All services are delivered in English.

Operating pharmaceutical activities without the required authorisation is a criminal offence in Romania

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

Types of Pharmaceutical Authorisation in Romania

Different authorisations are issued depending on the pharmaceutical activity. The main authorisation 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
  • Ministry of Health authorisation, with the application and inspection procedure involving the competent DSP

Wholesale Distribution
distribuție en-gros medicamente

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

Pharmaceutical Import
import produse farmaceutice

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

Manufacturing
fabricare medicamente

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

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

Community Pharmacy Authorisation (Farmacie Comunitară)

A community pharmacy (farmacie comunitară) is authorised to dispense prescription and over-the-counter medicinal products to the public. The operating authorisation is issued by the Romanian Ministry of Health, with the application and inspection procedure involving the competent County Public Health Directorate (DSP).

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 Ministry of Health 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. The competent authorities 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 the 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 for handling controlled substances. This is typically included as part of the pharmacy authorisation application.
DSP premises inspection As part of the pharmacy authorisation procedure, the competent DSP conducts the required premises assessment or inspection before the Ministry of Health issues the operating authorisation – confirming that the layout, equipment and storage conditions meet the requirements.
Pharmacy authorisation fee Applicable pharmacy authorisation fees are payable under the Ministry of Health authorisation procedure. Confirm current fees before proceeding.

Wholesale Pharmaceutical Distribution Authorisation (GDP Authorisation)

A wholesale distribution authorisation from ANMDMR 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 ANMDMR. 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 – ANMDMR 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 ANMDMR inspection.
ANMDMR GDP inspection Before issuing the wholesale distribution authorisation, ANMDMR 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 Authorisation Application Process – Step by Step

The application process for community pharmacy authorisation (Ministry of Health / DSP) and wholesale distribution (ANMDMR) follows structured procedures. Romania for Business Advisory S.R.L. coordinates the complete process in English.

01

Authorisation type & eligibility confirmed

02

Responsible Pharmacist / QPD identified

03

Premises secured & fitted out

04

GDP/GPP programme drafted

05

Community pharmacy authorisation dossier prepared for the competent DSP / Ministry of Health procedure

06

DSP / Ministry of Health submission & review

07

ANMDMR dossier prepared & submitted (wholesale)

08

Authorisation granted

Stage What happens
1. Eligibility and authorisation type We confirm the correct authorisation 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 authorisations: we assist in identifying a qualified pharmacist (farmacist-șef) registered with the Colegiul Farmaciștilor. For wholesale authorisations: we assess the QPD candidate’s qualifications and coordinate their 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 ANMDMR 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. Application dossier preparation For community pharmacies: we prepare the complete authorisation dossier for the competent DSP / Ministry of Health procedure – application forms, premises plans, equipment certificates, staff qualification documents and all required annexes. For wholesale distribution: we prepare the ANMDMR GDP dossier.
6. DSP inspection and review For community pharmacies: the competent DSP conducts the required premises assessment or inspection. We coordinate the inspection appointment and prepare the pharmacy director for the inspection visit. The DSP submits its recommendation to the Ministry of Health for the final authorisation decision.
7. ANMDMR review (wholesale) For wholesale distribution: ANMDMR reviews the dossier and may request additional information. We manage all ANMDMR correspondence – responding promptly to information requests to keep the review moving.
8. Authorisation and compliance For community pharmacies, the Ministry of Health issues the operating authorisation. For wholesale distribution, ANMDMR issues the relevant authorisation. We brief the client on all ongoing GDP/GPP obligations – periodic inspections, annual self-inspections, deviation reporting, recall procedures and licence renewal.

GDP and GPP – Ongoing Compliance Obligations

A pharmaceutical authorisation 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 authorisation. The competent authorities conduct periodic unannounced inspections of licensed premises.

Ongoing obligation What it means in practice
Periodic inspections ANMDMR conducts routine and unannounced GDP inspections of wholesale distributors. The Ministry of Health / DSP conducts inspections of community pharmacies. Inspection findings are classified by severity – critical, major and other deficiencies. Critical deficiencies can result in immediate authorisation 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 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. Authorities may conduct mock recalls as part of inspections.
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 the competent authority and, where required, approved before implementation.
Annual authorisation renewal Authorisations must be renewed periodically – the renewal interval depends on the authorisation type. Renewal requires confirmation that all conditions continue to be met and payment of the applicable renewal fee.
A GDP/GPP inspection deficiency notice does not mean immediate closure – but it requires a prompt corrective action plan

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 authorisation suspension. Romania for Business Advisory S.R.L. supports clients through inspection preparation and corrective action planning.

PHARMA AUTHORISATION – ROMANIA (ANMDMR / MINISTRY OF HEALTH)

from €2,000
engagement fee

PHARMA AUTHORISATION ENGAGEMENT INCLUDES:

  • Authorisation type assessment – community pharmacy, wholesale distribution or import
  • 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
  • Application preparation – all forms, technical documentation and dossier (DSP / Ministry of Health or ANMDMR)
  • DSP (County Health Directorate) coordination – pharmacy premises assessment
  • Authority submission and correspondence throughout the review period
  • Qualified Person (QP) documentation – for import and manufacturing activities
  • Authorisation condition compliance briefing – GDP/GPP ongoing obligations and renewal

INDICATIVE ENGAGEMENT FEES

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

Fees confirmed in writing after eligibility assessment. Regulatory authority fees are billed at cost separately. Pharmaceutical authorisation is a highly technical and document-intensive process – timeline and cost depend on the authorisation type and the applicant’s existing GDP/GPP infrastructure. Fees may be subject to Romanian VAT.

Frequently Asked Questions – Pharma Authorisation in Romania

ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) is the Romanian National Agency for Medicines and Medical Devices – the competent authority responsible for marketing authorisations, manufacturing/import authorisations and wholesale distribution authorisations for medicinal products. Community pharmacy operating authorisations are issued by the Romanian Ministry of Health, with the competent DSP involved in the application and inspection procedure.

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 community pharmacy must operate under the professional responsibility of a qualified pharmacist registered with the Romanian College of Pharmacists and meeting the statutory requirements.

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 Advisory S.R.L. 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 ANMDMR. A company cannot obtain a wholesale distribution authorisation from ANMDMR without demonstrating a GDP-compliant quality management system and premises.

The community pharmacy authorisation process typically takes 4–9 months from starting the premises fit-out to receiving the Ministry of Health operating authorisation. The main time drivers are: premises fit-out (typically 2–4 months), DSP inspection scheduling (2–6 weeks from application), authority review (4–8 weeks). The wholesale distribution authorisation process is typically 6–12 months – the GDP programme preparation and ANMDMR 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 authorisation 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 authorisation. The owner cannot substitute for the pharmacist requirement.

The competent authorities require community pharmacies to have a minimum usable floor area – typically 35–50 m² depending on the 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. The technical norms provide detailed layout specifications – we advise on these requirements before the premises are selected or fitted out.

A Romanian wholesale distribution authorisation permits the authorised wholesaler to conduct the activities covered by that authorisation, including cross-border distribution within the EU, subject to EU GDP requirements and the applicable rules governing medicinal products in the destination Member State. EU pharmaceutical law does not provide automatic passporting for wholesale distribution licences – each member state has its own licensing regime. Romania for Business Advisory S.R.L. advises on the correct approach for cross-border distribution.

ANMDMR conducts both routine and unannounced GDP inspections of wholesale distributors. The Ministry of Health / DSP conducts inspections of community pharmacies – typically 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.