The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. This guidance supports pharmaceutical companies in preparing for the United Kingdom's (UK) withdrawal from the European Union (EU). Now, the "Questions and Answers" (Q&As) document has been updated (Rev 04, published on 1 February 2019). The list of Q&As addresses the situation in which the United Kingdom becomes a third country upon 30 March 2019 without a withdrawal agreement (and hence without a transition period).
Questions & Answers on the unique identifier and multi-country packs
Some of the provided Q&As address the unique identifier (which is mandatory for most prescription medicines as of February 9, 2019), and multi-country packs:
Shall the information about the unique identifier uploaded to the UK repository between 9 February 2019 and 29 March 2019 be transferred to another repository in the Union?
According to the Delegated Regulation (EU) 2016/161, marketing authorization holders (MAHs) are required to ensure that unique identifiers (UIs) are uploaded to the Union repository system before a product is released for sale or distribution. Any information uploaded to the Union hub or a national repository should be transferred and stored in all national or supranational repositories where the product is intended to be placed on market. The information on products released on the market before the Brexit date will therefore already be present in the national repositories. Hence, there is no need to transfer information from the UK repository.
Can activities related to safety features take place in the UK?
The manufacturer is actually affixing the UI and anti-tampering device on the packaging. There is no requirement that such a manufacturer has to be located in the Union (EEA). However, if a manufacturer is not in the Union (EEA), then the obligation to ensure compliance with the Delegated Regulation lies with the importer.
The QP at the batch release site in the Union (EEA) will have to ensure that the safety features have been affixed to the packaging. This task may be delegated to appropriately trained personnel or third parties (according to Annex 16 / EU GMP guidelines).
The responsibility for ensuring that the information is uploaded in the repositories system lies with the MAH. The Delegated Regulation does not prohibit MAHs from subcontracting or delegating data-upload tasks to on-boarding partners (OBPs) acting on their behalf. However, the infrastructures, hardware and software used for data upload must be physically located in the EEA (see also Questions and Answers on Safety Features for Medicinal Products for Human Use).
How does UK’s withdrawal from the Union impact on the possibility to market a multi-country pack which includes the UK?
Multi-country packs are medicinal products that are labelled to allow their placing on the market in several Member States with the same packaging. Member States are allowed to require inclusion of certain additional labelling information in a restricted area (the so-called "blue box") provided that all the strict conditions for application of Directive 2001/83/EC and Directive 2001/82/EC are fulfilled.
In applying these provisions, multi-country packs with the UK market are only possible if - the product information is exactly the same in UK as in the EU27 (EEA), and - the Member State has allowed additional information labelled in the "blue box".
In any case, the labelling and package leaflet must be fully in line with the SmPC (Summary of Product Characteristics) as authorized in the Union (EEA).