Romania Pharmaceutical Licensing

Retail, wholesale and manufacturing/import are separate routes; one authorisation cannot be used for all of them. A community pharmacy must be established within a company organised under Romanian company law whose business purpose includes the retail sale of medicinal products. This guide does not specify the company form or capital.

The materials reviewed do not provide a uniform foreign-investment restriction that can be stated directly. Foreign investment, tax, local construction/fire-safety and environmental requirements must be confirmed separately; it must not be assumed that they are automatically permitted or that no requirements apply.

— Retail is for the public; wholesale is for the supply chain; manufacturing/import is authorised by site and activity.

The Ministry of Health issues authorisations for community pharmacies/drugstores; ANMDMR is responsible for wholesale, manufacturing/import, GDP/GMP and product authorisations. County or Bucharest Municipality public health directorates are responsible only for compliance, inspection and supervision of retail premises and do not constitute separate state-level licensing authorities.

Older legislation refers to ANM/ANMDM; these should now be understood as referring to ANMDMR. At the time of filing, use the forms and receiving authority published on the official website.

— Ministry of Health: retail and controlled substances; ANMDMR: supply chain, manufacturing and products.

A community pharmacy may retail prescription and non-prescription medicines under an operating authorisation issued by the Ministry of Health to the legal entity and the pharmacy manager. A drugstore has a narrower scope and cannot substitute for a pharmacy dispensing prescription medicines. As a rule, medicinal products sold at retail must have a marketing authorisation obtained in accordance with the law.

Medicinal products may not be sold on a self-service basis. Online sales are limited to non-prescription medicines sold by authorised pharmacies/drugstores, and require notification to the Ministry of Health and compliance with the conditions in the ministerial order; this does not confer online retail rights for prescription medicines.

— Closed-circuit pharmacies, rural/seasonal service points and drugstores must each comply with their respective rules.

Participants in the wholesale chain procuring, possessing, storing, supplying, trading and exporting medicinal products for human use must hold an ANMDMR wholesale authorisation; public retail sales are outside its scope. As a rule, only medicinal products with a marketing authorisation may be distributed; statutory exceptions require explicit approval.

Authorisation is based on a favourable GDP inspection. Every central site or service point must be included in the authorisation; repackaging and relabelling require a separate manufacturing authorisation.

— The wholesale scope of manufacturers/importers is limited to the medicinal products specified in their respective authorisations.

An ANMDMR manufacturing/import authorisation is required to manufacture medicinal products for human use or investigational medicinal products in Romania, and to import such products from third countries. The manufacturing scope includes all or partial manufacturing, packaging, repackaging and relabelling. New sites must be applied for and pass a GMP inspection.

Products also require the applicable national, MRP/DCP or EU centralised marketing authorisation before being placed on the market; a manufacturing authorisation does not replace a marketing authorisation.

— An importer without its own warehouse must submit, under the manufacturing order, a service contract with an authorised wholesale warehouse.

The community pharmacy manager must submit evidence of full-time, eight-hour employment/professional practice, proof of membership of the pharmacists’ association and current professional credentials; while the pharmacy is operating, at least one pharmacist must be present and personally practising.

Each wholesale unit must have a responsible pharmacist and a quality responsible person. The quality responsible person may be a pharmacist, a qualified person recognised by ANMDMR, or a doctor, chemist or biologist with at least one year of relevant practical experience. The publicly available evidence is insufficient to establish the full requirements for manufacturing qualified persons; wholesale rules cannot be substituted for them.

— Alternate wholesale responsible persons must have the same qualifications.

For retail, submit the business-premises registration, proof of right to use the premises, floor plans and equipment list; the premises are then inspected by the local public health directorate. A community pharmacy is generally located on the ground floor with direct access from the street (except for statutory exceptions), and must have a minimum usable area of 50 square metres, excluding corridors and toilets.

New urban pharmacies are subject to population standards: 3,000 people per pharmacy in Bucharest, 3,500 in county-seat cities and 4,000 in other cities. These are statutory population ratios, not self-invented distance or protection-radius requirements. No uniform square-metre figure for wholesale/manufacturing can be safely cited; premises should be assessed according to GDP/GMP and site information.

— Wholesale applications must include site plans/descriptions; manufacturing applications must include site master files for each location.

For retail, submit documents concerning the legal entity, manager, professional credentials, premises, floor plans and equipment to the Ministry of Health, after which the local public health directorate conducts an inspection. For wholesale, submit the inspection application, standard dossier, responsible-person details and site information to ANMDMR; manufacturing/import applications require, in addition, site master files and import-specific documents.

Incomplete documentation triggers a request for additional information and suspends the relevant statutory time limits. If deficiencies are identified during inspection, corrective and preventive actions must be submitted as required; the initial filing date must not be treated as the approval date.

— The Ministry of Health website provides forms for holders, responsible persons, changes of address and authorisation inspections; ANMDMR uses the relevant technical dossier.

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The wholesale and manufacturing regulations both provide for milestones such as a response within 10 days after complete documentation is received, an inspection usually within 10 days after payment is confirmed, and issuance within a maximum of 90 days after a complete application; requests for additional information suspend the time limits. Separate milestones apply to manufacturing inspection reports, deficiencies and CAPA.

Wholesale authorisations are valid for an indefinite period but remain subject to risk-based inspections and GDP requirements; subsequent manufacturing inspections are scheduled according to risk and the previous report. Current ANMDMR fees have not been safely verified, and historical retail fees or timelines are not presented as commitments.

— All time limits are subject to complete documentation, payment and actual inspection conditions.

Retail operations must continuously comply with good pharmacy practice, authorisation conditions and rules governing professional personnel. Wholesalers must comply with GDP, retain supply-chain traceability records, and submit a list of distributed medicines to ANMDMR every 6 months; subsequent inspections are risk-based.

Manufacturers/importers must maintain GMP compliance and submit CAPA following inspection deficiencies. If the fundamental conditions for authorisation are no longer met, ANMDMR may suspend or withdraw the wholesale or manufacturing authorisation.

— An authorisation with no fixed expiry does not mean inspections or record updates are unnecessary.

The retail authorisation identifies the legal entity and the responsible person. The Ministry of Health publishes procedures for holders, responsible persons, relocation, reissuance and replacement of lost authorisations; changes in shareholding, assets or the responsible person must not be described as automatically transferring the licence. A new premises may begin operating only after it meets the authorisation conditions, passes a favourable inspection and is registered.

Any changes to wholesale and manufacturing authorisations must be notified to ANMDMR in advance. Administrative changes may be based on updated documents, while technical changes may require a favourable inspection and a new authorisation/annex.

— Cessation of business, cancellation, bankruptcy or non-compliance may also trigger suspension, withdrawal or cancellation.

Product marketing authorisation is separate from establishment authorisation. ANMDMR lists national, MRP/DCP, parallel import, special-needs and EU centralised procedures separately; as a rule, retail and wholesale operators may handle only medicines with a valid marketing authorisation.

The manufacture, import and import/export of controlled narcotic drugs or psychotropic substances are separately governed by Law No. 339/2005. The Ministry of Health's import/export certificate requirements include a general business authorisation and a separate authorisation for activities involving controlled substances; trade with non-EU/EEA countries also requires ANMDMR import/export authorisation.

— Holding a pharmacy, wholesale or manufacturing authorisation does not allow product, controlled-substance or cross-border procedures to be bypassed.