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Addressing the manufacturing challenges of Brexit

Simon McKeever

Chief Executive, Irish Exporters Association

The UK’s departure from the EU will have significant consequences on multiple aspects of manufacturing. This includes: regulatory approval, supply chain and manufacturing process for companies producing active substances and final goods in the UK.

The European Union very strict health and safety manufacturing rules and requirement on human and veterinary medicinal products.

Once the UK leaves the European Union – on 29 March or following a potential transition period – the United Kingdom and goods manufactured within the UK will be classified as a third-country and third-country manufactured product. Therefore, any medicinal/pharmaceutical product manufactured by UK marketing authorisation holders will have to follow EU rules on imported pharmaceutical goods.

The exclusive use of authorised manufacturers is lead by EU legislation. Good manufacturing practices for starting materials list detailed guidelines manufacturing must be in accordance with.

Written approval needed for UK medicinal exports to EU

Similarly, EU import of active substances for human use medicinal products must follow these guidelines.For example, active substances are accompanied by a written confirmation from a relevant competent authority in the exporting third country. This confirms the standards of good manufacturing practice and control of the plant are equivalent to those in the Union.

If the final manufacturing site of a product is located in the United Kingdom following Brexit, rules apply. The European Union legislation stipulates strict rules on the importation of medicinal products from third countries. Under EU legislation, importers of medicinal and other pharmaceutical goods must be in possession of manufacturing licenses granted by national competent authorities. This is under Article 40(3) of Directive 2001/83/EC and Article 44(3) of Directive 2001/82/EC. A number of conditions may grant third-part manufacturers licenses.. Conditions can include EU-licensed representatives and inspected goods-manufacturing processes.

Medicinal manufacturing processes must adapt to comply

According to EU-Brexit notices, for centrally authorised medicinal products, UK marketing authorisation holders must therefore need to specify an authorised importer established in the Union and submit the corresponding variation.

Moreover, to ensure continued validity, marketing authorisation term changes may need to be considered.

Furthermore, when importing medicinal and other pharmaceutical goods from a third-country into the EU, UK marketing authorisation holders are required to specify an EU-based site of batch control in order to facilitate full qualitative and quantitative tests, among others, on each production batch of at least all active substances as required by the national competent authority.

For further information on how to prepare and mitigate the impacts of Brexit on your business, consult:

The HPRA, European Commission or European Medicines Agency.

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