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Brexit & medicinal products

Created 03/01/2019 12:46

 Do you have a manufacturing site of your finished product located in the UK?

In the event of no deal, the UK would no longer be part of the EMA. As of the date of the withdrawal of the UK from the Union, medicinal products manufactured in the UK will thus be considered imported medicinal products.

 

For centrally authorised medicinal products the marketing authorisation holder will need to change the location of its current UK based site of batch control to a location established in the Union (EEA) and to specify an authorised importer established in the Union (EEA). In addition, in accordance with Article 51(1)(b) of Directive 2001/83 the marketing authorisation holder will need to specify a site of batch control in the Union (EEA) where each production batch can undergo upon importation a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation.

 

Vitas provide a range of both GMP and non GMP analytical services to the pharmaceutical and nutraceutical industry.  Vitas holds a Manufacturing Authorisation (1.6  Quality control testing; 1.6.3   Chemical/Physical) issued by the Norwegian Medicines Agency since 2010, and can perform analysis as a sub-contractor.

 

Our services range from a single test to full method development, validation, stability testing, release, tech-transfer, impurity characterization, high throughput study sample analysis, documentation and regulatory support. The laboratory  is equipped with modern instrumentation including UPLC, HPLC, LC-MS/MS, LC-TOF-HRMS, GC, GC-MS, ICP-MS, Karl Fischer, IR, and dissolution systems is operated by well-trained and highly motivated staff with an average of over 10 years of practical experience in the pharmaceutical industry.

 

If you see that this will be or might become a problem for your organization and that you may need assistance with chemical analysis of medicinal products after Brexit, please contact us.