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Focus on Regulation

Poland: Impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for medicinal products

The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques.[1]

The first Brexit related communique concerned changes to: data which was included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products. The second concerned the impact of Brexit on the validity of parallel import licences.

  1. Data included within marketing permissions, data made available on the market, and data concerning the use of biocidal products

In the event of a no-deal Brexit, the President of the Office has recommended the immediate introduction of the following changes to the relevant documentation:

– the change of a biocidal product’s marketing authorisation holder to entities established or represented in the EU (EEA countries, or Switzerland),

– the change of the authorisation holder for making data available on the market, and data concerning the use of biocidal products, to holders established or represented in the EU (EEA countries, or Switzerland).

At the same time, the Office has asked companies to keep up to date with the information published on the websites of the European Chemicals Agency (ECHA)[2].

Moreover, suppliers of the active substances or biocidal products included in the list referred to in Article 95 of Regulation (EU) No 528/2012 concerning biocidal products must be established or represented in the EU (EEA, or Switzerland).

  1. Validity of parallel import licences for medicinal products

In case of a no-deal Brexit, medicinal products with parallel import licenses, in which the UK is indicated as the exporting country, will no longer be considered as having been imported from a member state of the EU, or a member state of the European Free Trade Agreement (EFTA), but instead from a third country.

Therefore, these medicinal products will be imported into Poland contrary to the definition of a parallel import as defined in the Polish pharmaceutical law. As a result, any parallel import licences in which the UK is designated as an exporting country will be revoked after the Brexit date.

The new communique provides further information in relation to the impact of Brexit on the Life Sciences & Healthcare industry in Poland after the release of the Polish Minister of Health’s statement on the effects of Brexit on reimbursement of 6 December 2018, the communique concerning necessary post-registration changes in medicinal product documentation of 25 February 2019, and the communique on the consequences of a no-deal Brexit for medical devices of 1 March 2019.

 

 

[1]              The communiques were issued only in Polish and can be found on the official website of the office: Changes to data included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products in relation to Brexit and The impact of Brexit on the validity of parallel import licences

[2]              https://echa.europa.eu/pl/advice-to-companies-q-as/bpr