1
The Responsible Person employed by the holder of the marketing authorisation decides on the market release of a batch before it is placed on the market.
2
They check whether:
a.
a valid batch certificate issued by the manufacturer is available and whether the batch was manufactured in conformity with the GMP rules described in Annex 1;
b.
the batch in question fulfils the requirements of the authorisation;
c.
the conditions described in Articles 11 and 12 have been fulfilled; and
d.
the entire supply chain is in conformity with the authorisation and the GDP5 rules described in Annex 4.
3
Swissmedic may specify additional checks.
4
The Responsible Person confirms that the checks described in paragraphs 2 and 3 have been performed.