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Polish inspectorate issues ruling on the import of medicinal products

PolandUkraine
11/07/2024
Available languages: PL
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On 8 July 2024, Poland’s Chief Pharmaceutical Inspectorate (GIF) published a decision interpreting the definition in Pharmaceutical Law regarding import of a medicinal product.

The decision, published on the GIF’s website, resulted after an applicant had requested an individual interpretation regarding two business models on whether these models required an import licence.

In both models, delivery of the medicinal product was to a third party based in Ukraine, where the product would be released for marketing in the Lithuanian market. The models differed in the following ways:

  • in the first model, the product would be delivered to the applicant (i.e. to its pharmaceutical wholesaler in Poland) from where it would be sold to the Lithuanian market.
  • in the second model, the product would be transported straight away to Lithuania, the target country. In terms of ownership, the product would first be purchased by the applicant, but it would never reach the Applicant's pharmaceutical wholesaler located in Poland.

In its decision, the GIF indicated that any activity bringing a medicinal product into the territory of Poland from outside the EU or EFTA - parties to the EEA Agreement (e.g. Ukraine), which involves:

  • storage
  • quality control at batch release
  • distribution

constitutes an import requiring GIF authorisation. If, however, the business activity does not involve importing a medicinal product into Poland, it does not constitute an import of a medicinal product and does not require import authorisation.

For more information on this decision and regulations regarding the import of medicinal products into Poland, contact your CMS client partner or these CMS experts.

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