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ARTICLE · 25 MAY 2021

SPC Manufacturing Waiver - May 2021

J A Kemp
J A Kemp
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J A Kemp

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With the entry into force of Regulation (EU) 2019/933 on 1 July 2019, the EU introduced a so-called "manufacturing waiver" by amending existing Regulation (EC) 469/2009 concerning supplementary protection certificates.

United KingdomIntellectual Property
Graham Lewis
Graham Lewis
Chris Milton
Chris Milton
Ravi Srinivasan
Ravi Srinivasan
Andrew Webb
Andrew Webb
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With the entry into force of Regulation (EU) 2019/933 on 1 July 2019, the EU introduced a so-called "manufacturing waiver" by amending existing Regulation (EC) 469/2009 concerning supplementary protection certificates (SPCs).

Scope of the manufacturing waiver

The amendments to the existing SPC Regulation have excluded certain acts from the protection conferred by SPCs.

In particular, a third party (referred to as a "maker") is permitted to manufacture a medicinal product protected by an SPC for the exclusive purpose of export to countries outside the EU1.

The rights of manufacture include authorisation for ancillary activities which are "strictly necessary" to enable the manufacture and export of the product. These include, for example, the importation of API into the EU to enable the preparation of a formulated medicinal product and the temporary storage of product or medicinal product within the EU for the exclusive purpose of export to countries outside the

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