The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is Poland's national regulatory authority under the Ministry of Health, granting marketing authorisations, clinical trial approvals, and device certifications for pharmaceutical, medical device, and biocidal product companies operating in Poland.
- Company typePrivate
- Founded2011
- HeadquartersWarsaw, Poland
- Headcount501–1,000
- GTM typeB2B
- OfferingServices
What The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products does
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, URPL) is a Polish government administrative agency established in 2011 under the Act of 18 March 2011 (Journal of Laws 2011, No 82, item 451), operating under the supervision of Poland's Ministry of Health. Headquartered at Al. Jerozolimskie 181C, Warsaw, with 501-1000 employees, it serves as Poland's sole competent national authority for regulatory oversight across four domains: human medicinal products, veterinary medicinal products, medical devices, and biocidal products. Its mandate includes granting marketing authorisations, parallel import licences, clinical trial approvals, and medical device certifications; maintaining statutory registers; conducting pharmacovigilance and clinical trial inspections; and issuing safety communications and Certificates of Free Sale.
The Office operates several domain-specialised information systems including POBIS (Biocidal Products Information System), the Pharmacovigilance Monitoring System (SMZ), the Central Register of Clinical Trials, the Medical Devices Database, and electronic submission infrastructure supporting eCTD, NeeS, and VNeeS formats. It maintains official registers published in the Public Information Bulletin (BIP) and the Polish Official Journal, including the Official Register of Medicinal Products and the List of Biocidal Products. It also publishes the Polish Pharmacopoeia and runs the public education campaign "Lek Bezpieczny" (Safe Medicine). The Office engages internationally as Poland's interface with the European Medicines Agency (EMA), the CMDh coordination group, and the EU regulatory network for medical devices under EU Regulation 2017/745.
The Office's revenue model combines state budget allocations with statutory regulatory fees set by Polish law. Fees apply to marketing authorisation procedures, parallel import licences, clinical trial authorisations, biocidal product registrations, and medical device certifications, with specific schedules published at gov.pl/web/urpl/oplaty. Distribution is conducted exclusively through domestic government channels — the gov.pl portal, ePUAP (Electronic Platform of Public Administration Services), the Warsaw headquarters, and specialised online registries. It has no commercial product lines, no M&A activity, no external funding rounds, and is not publicly traded.
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products firmographics
Firmographics- Name
- The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal name
- Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
- Website
- https://urpl.gov.pl
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 501–1,000 employees
- Short description
- The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is Poland's national regulatory authority under the Ministry of Health, granting marketing authorisations, clinical trial approvals, and device certifications for pharmaceutical, medical device, and biocidal product companies operating in Poland.
- Ownership category
- akta.pro rank
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products industry classification
Industry- Product category
- Pharmaceutical and Medical Device Regulation
- NAICS
- Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615)
- SIC
- Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)
Keywords
Where The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is headquartered
LocationHeadquarters
- HQ city
- Warsaw
- HQ country
- Poland
- HQ region
- Europe
Offices1 record
Markets served
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Others
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Fee-based regulatory services under statutory fee schedules |
Distribution channels4 records
Marketing channels5 records
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products product offering
Product offeringCore offering
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is a Polish government regulatory authority that grants legally binding marketing authorisations, parallel import licences, and clinical trial approvals for medicinal products (human and veterinary), medical devices, and biocidal products. It maintains official statutory registers, conducts pharmacovigilance and inspections, issues Certificates of Free Sale, and publishes the Polish Pharmacopoeia under the Act of 18 March 2011.
Product overview
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is a Polish government regulatory agency that does not offer commercial products but provides public administrative services in three core regulatory domains: medicinal products (human), veterinary medicinal products, medical devices, and biocidal products. The agency maintains several information systems including registries, the Public Information Bulletin (BIP), the POBIS system for biocidal product registration, and the pharmacopoeia publication service. Core regulatory services include granting marketing authorizations, conducting clinical trial inspections, pharmacovigilance monitoring, and maintaining official registers of authorized products. The agency also conducts public health education campaigns such as the 'Safe Medicine' (Lek Bezpieczny) initiative and publishes the Polish Pharmacopoeia.
Differentiator
Problem solved
Functional benefit
Products and services
- Medicinal Products Registration Services Procedures and activities for human medicinal products, including granting marketing authorisations, parallel import licences, maintaining the Official Register of Medicinal Products, and issuing decisions on clinical trial authorisations for pharmaceutical and biopharmaceutical companies seeking market access in Poland.
- Veterinary Medicinal Products Services Procedures for veterinary medicinal products including marketing authorisations, maintaining the register of veterinary products, pharmacovigilance monitoring, and clinical trial inspections for veterinary products for animal health companies operating in Poland.
- Medical Devices Services Activities involving safety, marketing, and use of medical devices, including issuing regulatory decisions, keeping a database of reports and notifications, supervising medical incidents, classifying medical devices and in-vitro diagnostics, and issuing Certificates of Free Sale for manufacturers and distributors.
- Biocidal Products Services Procedures for biocidal products including granting market authorisations, keeping the List of Biocidal Products, evaluating dossiers for active substance approvals, parallel trade authorisations, and maintaining a register of poisonings for manufacturers, importers, and distributors.
- Pharmacopoeia (Farmakopea) Official publication of the Polish Pharmacopoeia and European Pharmacopoeia updates, including the issuance of monographs and chapters for pharmaceutical substances and products for pharmaceutical manufacturers, quality control laboratories, and regulatory professionals.
- Public Information Bulletin (BIP) Public Information Bulletin (Biuletyn Informacji Publicznej) providing access to official announcements, job postings, procurement notices, financial reports, organisational structure, and other mandatory public disclosures for citizens and businesses.
- Lek Bezpieczny (Safe Medicine) Public Health Campaign Public education campaign promoting safe use of medicines, including reporting adverse drug reactions and raising awareness about medication safety among healthcare professionals and the general public.
Quantifiable outcome
- Maintains the Official Register of Medicinal Products Authorised in the territory of the Republic of Poland and publishes the Official List of Medicinal Products at least annually in the Official Journal of the minister competent for health.
- +1 more outcomes
Companies that use The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Customer profileSegments4 records
Ideal customer profiles3 records
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- European Medicines Agency (EMA)coreThe Office cooperates with the European Medicines Agency as part of Poland's participation in the EU regulatory network for medicinal products. This includes engagement in EMA scientific committees, participation in the Management Board of the EMA (as evidenced by the 132nd and 124th Management Board meeting communications), and exchange of safety information.
- CMDh Coordination Group (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human)corePoland participates in the CMDh coordination group through the Office. Regular updates are published as 'Informacja Prezesa Urzędu' regarding CMDh meetings (e.g., meetings held 23-25 June 2026 and 17-18 September 2024). The CMDh coordinates on mutual recognition, decentralised procedures, and harmonisation of decisions across EU Member States.
- EU Regulatory Network for Medical DevicescoreThe Office serves as the competent authority for medical devices in Poland under EU Regulation 2017/745. It cooperates with European Commission guidelines and EU-level regulatory bodies for medical device oversight, including exchange of safety information with international organisations. The Office publishes European Commission guidelines on new EU medical device regulations.
Scale indicators2 records
Recent moves5 records
Expansion highlights4 records
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products competitors and assessment
Company assessmentDirect peers
- ANSM (French National Agency for Medicines and Health Products Safety): France's national medicines and health products regulator. Comparable in scope across human medicines, medical devices, and pharmacovigilance, and a fellow CMDh/EMA participant operating similar statutory regulatory functions.
- Danish Medicines Agency (Lægemiddelstyrelsen): Denmark's national medicines and medical devices regulator. Comparable in scope across human and veterinary medicines and medical devices, and a fellow CMDh and EU regulatory network participant with similar statutory fee structures.
- Paul-Ehrlich-Institut (PEI, Germany): German federal institute for vaccines and biomedicines. Comparable as a specialised national regulator focused on biological medicinal products, vaccines, and gene therapies — areas that intersect with URPL's biological product oversight responsibilities.
- MHRA (Medicines and Healthcare products Regulatory Agency, UK): UK's national regulator for medicines, medical devices, and blood components. Directly comparable in statutory mandate covering marketing authorisations, clinical trial approvals, and pharmacovigilance; now operating outside the EU network post-Brexit but functionally analogous.
- AEMPS (Spanish Agency for Medicines and Health Products): Spain's national medicines and health products regulator. Directly comparable in scope across medicinal products, medical devices, cosmetics, and biocidal products oversight, with similar statutory authority and EU network integration.
- BfArM (Federal Institute for Drugs and Medical Devices, Germany): Germany's federal regulator for medicinal products and medical devices. Directly comparable national competent authority performing marketing authorisations, pharmacovigilance, and medical device oversight, and a co-participant in CMDh and EU regulatory procedures with URPL.
Emerging players
- ECHA (European Chemicals Agency): EU agency managing biocidal products regulation under the Biocidal Products Regulation. Comparable because URPL's biocidal products mandate operates in close coordination with ECHA, particularly on active substance approvals and the Article 95 list.
Regional players
- HALMED (Agency for Medicinal Products and Medical Devices, Croatia): Croatia's national medicines and medical devices regulator. Comparable in functional mandate covering marketing authorisations, pharmacovigilance, and medical device oversight; smaller in scale and operating in a different EU Member State than URPL.
Broad incumbents
- European Medicines Agency (EMA): EU-level agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. Directly comparable as a higher-tier regulatory body with which URPL cooperates on marketing authorisations, pharmacovigilance, and clinical trial oversight.
- FDA (U.S. Food and Drug Administration): U.S. federal regulator with the broadest comparable mandate covering medicines, medical devices, biologics, and related product categories. Functionally analogous to URPL in statutory authority, although operating under a different legal framework and outside the EU network.
Market position
Strengths1 record
Weaknesses1 record
Competitive moat3 records
Key risks6 records
Key highlights7 records
Customer concentration
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products social profiles
Digital presenceThe Office for Registration of Medicinal Products, Medical Devices and Biocidal Products financial estimates
Financial estimateRevenue estimate
Valuation estimate
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products leadership team
Management profileNumber of profiles
Profiles1 record
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
What does The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products do?
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is a Polish government regulatory authority that grants legally binding marketing authorisations, parallel import licences, and clinical trial approvals for medicinal products (human and veterinary), medical devices, and biocidal products. It maintains official statutory registers, conducts pharmacovigilance and inspections, issues Certificates of Free Sale, and publishes the Polish Pharmacopoeia under the Act of 18 March 2011.
Is The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products a public or private company?
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is a private company. It is classified as state government owned and is currently operating.
When was The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products founded?
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products was founded in 2011. It employs 501 to 1,000 people.
Where is The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products based?
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is headquartered in Warsaw, Poland, in the Europe region.
Who are The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products's main competitors?
Direct peers on record are ANSM (French National Agency for Medicines and Health Products Safety), Danish Medicines Agency (Lægemiddelstyrelsen), Paul-Ehrlich-Institut (PEI, Germany), MHRA (Medicines and Healthcare products Regulatory Agency, UK), AEMPS (Spanish Agency for Medicines and Health Products) and BfArM (Federal Institute for Drugs and Medical Devices, Germany). ECHA (European Chemicals Agency) is listed as an emerging player. HALMED (Agency for Medicinal Products and Medical Devices, Croatia) is listed as a regional player. Broad incumbents are European Medicines Agency (EMA) and FDA (U.S. Food and Drug Administration).
Does The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products have an API?
No public API is recorded for The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
What industry is The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in?
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products's product category is Pharmaceutical and Medical Device Regulation. Its primary akta.pro industry code is HLAJADAI, Regulatory Affairs, Labeling & Advertising/Promotion Compliance. Its NAICS code is 92615 and its SIC code is 2834.