CPI Foreign Inspections
09.01.2026
Medicinal products authorised for marketing in Poland - regardless of whether they are manufactured in EU/EEA Member States or in third countries such as China, India, Vietnam, or South Korea - must comply with European Good Manufacturing Practice (GMP) requirements.
Verifying and confirming that manufacturers in third countries meet these standards – essential for ensuring the quality, safety, and efficacy of medicinal products – is one of the key tasks of the Chief Pharmaceutical Inspectorate. In 2024–2025 alone, inspectors travelled a total of 370,000 kilometres to conduct inspections abroad – a distance comparable to circling the Earth along the equator more than nine times. During this period, inspections were carried out on three continents, in eight countries, across seven time zones.
Inspections of manufacturers operating in third countries are conducted at the request of marketing authorisation holders – when applying for a marketing authorisation or for a variation involving a change of manufacturing site – importers of medicinal products bringing products into Poland from third countries, as well as EU/EEA Member States, the European Medicines Agency (EMA), or the European Commission.
The purpose of these inspections is to assess compliance of manufacturing conditions with GMP requirements. A positive inspection outcome results in the issuance of a GMP certificate, which is subsequently published in the publicly accessible EudraGMDP database.
Holding a valid GMP certificate is a prerequisite for placing a medicinal product on the Polish market. It provides assurance that manufacturers in third countries comply with the stringent Good Manufacturing Practice standards applicable within the European Union.