Regulation 60
(1)
Article 13 (duration of the certificate) is amended as follows.
(2)
In paragraph 1, for “the Community”, substitute “the area comprising the European Economic Area and the United Kingdom”.
(3)
In paragraph 3, for “Article 36 of Regulation (EC) No 1901/2006”, substitute “regulation 58A of the Human Medicines Regulations 2012”.