EC Wants Info on API Import Law-Related Shortages

By Gareth Macdonald

- Last updated on GMT

EC Wants Info on API Import Law-Related Shortages
EC Wants Info on API Import Law-Related Shortages

Related tags: European union

The European Commission (EC) has again asked pharmaceutical to let it know about drug shortages caused by new API import laws that come into effect tomorrow.

The call came in a letter to the EGA, EFPIA and AESGP by DG-SANCO last week that was prompted by manufacturers’ concerns the requirement that actives shipped to the European Union come with ‘written confirmation’ of quality would disrupt supplies.

In response, DG SANCO director general Paola Testori Coggi wrote that: “I would like to assure you that the Commission takes industry concerns very seriously.

“We will keep going out of our way to prevent any shortages of medicines and, more generally, to ensure the continuity and safety of the supply chain, and a level playing field for all industry actors regardless of where they are located.”

She added that: “The Commission would like to ask you to share with all relevant authorities, immediately and at the earliest possible stage of detection, complete and detailed information on any specific problem concerning the lack of active ingredients, so as to enable authorities to provide a proper response at the EU level.”

Specific details of the ‘proper response’ were not provided so it is unclear if the European Commission will consider making exceptions when there is an overriding need to ensure continued supply, which is the approach currently being considered by the UK MHRA​.

The EGA and AESGP did not respond to request for comment ahead of publication and the EFPIA said it is preparing a statement on the issue that it will publish tomorrow.

Related topics: Markets & Regulations

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