SPC & Brexit - Recent Updates
Recently,
EU commission published short document on Supplementary Protection
Certificates (SPC) of Medicinal Product & Plant Product and Brexit.
As
mentioned in short documents SPC calculation is as below:
An
authorisation to place the product on the market granted by a United Kingdom
competent authority as of the withdrawal date will not be considered a first
authorisation to place the product on the market in the European Union for the
purposes of Article 13 of Regulation (EC) No 469/2009 and Article 13 of
Regulation (EC) No 1610/96.
However,
an authorisation to place the product on the market granted by a United Kingdom
competent authority before the withdrawal date is to be considered as the first
authorisation to place the product on the market in the European Union for the
purposes of Article 13 of Regulation (EC) No 469/2009 and Article 13 of Regulation
(EC) No 1610/96 on the duration of the certificate.
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