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Brexit

MEMO TO ALL ECONOMIC OPERATORSBREXIT

Pursuant to Article 50 of the Treaty on European Union, the United Kingdom is expected to withdraw from the Union from 30th March 2019.  This means that unless the withdrawal agreement establishes another date or the period is extended by the European Council in accordance with Article 50(3) of the Treaty on European Union, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET), the United Kingdom will then become a 'third country.'

Undoubtedly this will have will have significant implications to businesses in Malta and the Pharmaceutical industry is no exception.


This will have significant ramifications on registered medicinal products (both national registration and centrally authorized) which have UK as country of source.


This may create significant disruptions in the supply of medicines with significant risk of product shortages in terms of pharmaceuticals.


In order to minimize such disruptions, CPSU wishes to work closely with all Economic Operators and provide the required support.  In order to any bottle necks, we would like to encourage all affected economic operators to initiate the process, if not already started in identifying an alternative medicinal product with country source from the EU immediately.


In line with Articles 22 and 38 of Contract Conditions,  Economic operators may submit an offer for an alternative product with EU as source country for evaluation.


All Economic Operators who currently have an active contract with CPSU for the supply of a medicinal product with UK as the country of source are encouraged to submit an offer for an alternative product with country source from the EU.  It is noted that such medicinal products may be already registered with the Medicines Authority.  If this is not the case, the economic operator may offer an alternative which it intends to register with the Medicines Authority.


Technical documentation that needs to be submitted online through the prescribed Tender Response Format with each offer as per Article 2.1 of Section 4 of Tender dossier ‘Specifications’.

The Economic Operator will be notified immediately on completion of the evaluation as per established procedure.


All Economic Operators are reminded that all conditions of contract will remain binding.


Your cooperation is greatly appreciated.


CPSU  will gladly answer any queries that you may have with regards to the procedure to be followed.


Kindest regards,

Karl 


Ing Karl Farrugia - Chief Executive Officer

Central Procurement and Supplies Unit (CPSU)

UB002 San Gwann Industrial Estate 

San Gwann (SGN 3000) | Malta

Department Of Health (DOH)  Ministry for Health (MFH)

e: karl.farrugia@gov.mt m: +356 79469637 t: 25454105