Fiscal Importation within the EEA - Discussion of ECA GDP Survey Results

During the recent ECA GDP survey on the implementation of GDP across member's countries, a number of interesting findings arose. We will discuss some of these in upcoming ECA GDP newsletters.

Part 1

The first topic to discuss is the current status of fiscal importation requirements within the EEA.

From a wholesaling perspective, fiscal (only) importation refers to a wholesaler procuring a finished medicinal product from a supplier based outside of the EEA, with the product being received physically from an EEA based location, and the product being certified and released for sale on the EEA market by an EEA based manufacturer.

The first conclusion from the question on fiscal importation is that many members are unsure of the requirements within their own country, i.e. whether fiscal importation is allowed to be conducted as a wholesaler, or whether a manufacturing authorisation is required. 35% of respondents answered "Not sure" when asked the question. This reflects the current lack of clarity being available to the industry both from a central and national perspective. It should also be noted that there were also a number of contradictory answers, where one respondent said a WDA was required within their country, with another respondent stating an MIA was required in that country. This may also reflect the fact that this topic is not relevant to many wholesalers within the EEA as they only procure from other EEA based suppliers; however, for those that do procure from outside the EEA, it is a very important topic.

13% of respondents stated that a wholesaler can fiscally import when not physically importing. 29% stated that an MIA was required for fiscal importation. Looking at the results which provided the clearest answers shows that Norway, Sweden, Belgium and Germany are the countries most likely to require a manufacturer's authorisation to fiscally import finished products. The Netherlands and Ireland were the clearest responses relating to a wholesaler being allowed to fiscally import product. A number of respondents stated that the local competent authority decides on a case-by-case basis.

The clearest conclusion from the survey on fiscal importation is that if you intend to conduct this activity, you should contact your local competent authority to verify its current position.

It should also be noted that Article 166 of the proposed update to EU legislation relating to the wholesale of medicinal products (i.e. 2023/0132(COD) Directive on medicinal products for human use) states that wholesalers "…may only obtain, including by financial transactions, their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation in the Union or a manufacturing authorisation…'" Whilst a final version of the Directive has not been published, wholesalers fiscally importing product should be aware of these potential changes.

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