OUR SAFETY STANDARDS
Quality in every process
Urtica’s Quality Management System meets the requirements for the marketing of medicinal products and forms an integral part of the company’s day-to-day operations. It comprises clearly defined processes, responsibilities and codes of conduct, ensuring that all activities comply with applicable requirements and quality standards.
Discover our standardsFor hospitals and other healthcare facilities
OUR APPROACH
Ongoing monitoring of quality standards
We ensure the quality and safety of medicinal products at every stage of their supply chain. We implement and monitor processes that affect product quality, including the qualification of suppliers and recipients, as well as proper storage and distribution. We ensure that our activities comply with applicable requirements and standards, and in situations requiring intervention, we efficiently implement procedures relating to the suspension or withdrawal of a product from the market.
Qualified specialists are responsible for implementing quality processes and their day-to-day supervision; they work with the relevant inspection bodies and other institutions, and take part in external inspections and audits. Their task is not only to monitor compliance, but also to implement and improve solutions that support the proper functioning of the quality system.
THE TEAM
Quality in the hands of experts
Knowledge and experience in day-to-day practice
Quality processes are carried out under the supervision of the Person in Charge, with the support of qualified specialists possessing pharmaceutical knowledge and practical experience. Their expertise enables them to interpret the applicable requirements correctly, assess situations accurately and make decisions that ensure the activities carried out comply with legal provisions and accepted standards.
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skilled specialists
Standards and legal compliance
A guarantee of high quality standards
01 Certificates
Independent certificates, issued by authorised inspection bodies, confirm that our processes comply with legal requirements. These cover the monitoring of storage and transport conditions for medicinal products at every stage of the distribution chain.
Documents
02 Permits and licences
We operate on the basis of the following licences:
- Licence to operate a pharmaceutical wholesale business (GIF-N-411/1022/1-2/TL/16 dated 1 August 2016, as amended)
- Licence for the wholesale trade in narcotic drugs and psychotropic substances (GIF-N-4430/33/KK/16 dated 31 August 2016, as amended)
- Licence for the trade in Category 1 drug precursors (NFKS.5521.15.2025.KKW.3, valid until 22 August 2028)
- Permit No. D-24586 issued by the National Atomic Energy Agency on 5 December 2025 – for the storage of radioactive sources and waste in a warehouse
- Permit No. D-20900 issued by the National Atomic Energy Agency on 7 November 2018, as subsequently amended – for the trade in unsealed radioactive sources
03 Legal basis for operations
Our activities are based on national and EU regulations, including:
- The Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws 2001 No. 126, item 1381, as subsequently amended)
Regulation of the Minister of Health on Good Distribution Practice (GDP) (Journal of Laws of 2015, item 381, as amended) - European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (GDP 2013/C 343/01)
- Act of 29 July 2005 on Combating Drug Addiction (Journal of Laws 2005 No. 179, item 1485, as amended)
- Commission Delegated Regulation (EU) 2015/1011 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade in drug precursors between the Union and third countries and repealing Commission Regulation (EC) No 1277/2005
- Regulation of the Minister of Health of 9 November 2015 on the granting of authorisations for the manufacture, processing, import, distribution or use of narcotic drugs, psychotropic substances or Category 1 precursors (Journal of Laws of 25 November 2015, item 1951)
- Commission Delegated Regulation (EU) 2016/161 (FMD) – on the system for the serialisation and verification of the authenticity of medicinal products and the management of anti-counterfeiting measures
- The Atomic Energy Act of 29 November 2000 (Journal of Laws 2001 No. 3, item 18, as subsequently amended)
- The Act of 7 April 2022 on medical devices (Journal of Laws 2022, item 974)
- The Act of 19 August 2011 on the transport of dangerous goods and the ADR Agreement (Journal of Laws 2011 No. 227, item 1367, as amended)
- Act of 25 August 2006 on food and nutrition safety (Journal of Laws 2023, item 1448, as amended)
- The Act of 4 October 2018 on cosmetic products (Journal of Laws 2018, item 2227, as amended)
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