When is a WDA Required? - Discussion of the ECA GDP Survey Results

This is the second article discussing in some more detail some of the interesting findings from the recent ECA GDP survey on the implementation of GDP across member's countries. In the previous article, we discussed the current status of fiscal importation requirements within the EEA. In this article we will look at when a Wholesale Distribution Authorisation (WDA) is required in member countries.

Part 2

Two questions were included in the survey on this topic. The first was 'Is a Marketing Authorisation Holder (MAH) in your country obliged to have a WDA?'. In general, the responses to this question correspond with what we already know for the majority of countries, i.e. that an MAH requires a WDA if they are wholesaling. This means that if they buy, sell or hold medicinal products they require a WDA. We should also note that wholesaling relates to finished medicinal products, which implies batch release to the market by the manufacturer has been completed. Many MAHs own product throughout its manufacturing lifecycle. Therefore, if such an MAH sells a product following release to the market, they would require a WDA.

The second question was 'Does your competent authority require a Wholesale Distribution Authorisation if you are buying or selling medicinal products without physically handling them?'. The answers from participants clearly show that all Competent Authorities expect a WDA to be held by companies who buy or sell products, regardless of whether they hold the products themselves or outsource this.

An exception from the survey to the above questions within the EEA appears to be Italy, where the requirement for a WDA was reported to relate more to the physical storing of the product, and not to the ownership. This will be extremely relevant to MAHs and their affiliates who own product at logistics sites. If a member is establishing in Italy, they should verify the expectations of the local regulators relating to obtaining a WDA if not holding. Also, in the case of procuring from Italian suppliers or supplying to Italian customers without a WDA, members would be advised to ensure that they document their reasoning for accepting this status, and to ensure that there is documentation to back up this status, for example, confirmation from local regulators or legislative extracts.

Also to note, as with other answers from participants within the survey, there were conflicting answers from each country. This again highlights the potential gap between the knowledge of industry professionals and the expectations of competent authorities.

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