40. Regulation (EC) No 469/2009(1) of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products is amended as set out in the Schedule.
41.—(1) Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products is amended as follows.
(2) After Article 2 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.
42. In the Patents Rules 2007(2), after rule 116, insert—
116A. Notifications under Article 5(2)(b) and (c) of the Medicinal Products Regulation must be made on Patents Form SP5.”.
43.—(1) Paragraph (2) applies where, before IP completion day, a product or a medicinal product containing that product, as defined in Article 1 of Regulation EC (No) 469/2009, is marked in accordance with that Regulation with the logo set out in Annex -I of that Regulation.
(2) That product or medicinal product containing that product so marked is not required, after these Regulations come into force, to have the words “UK export” affixed to it.
(3) Paragraph (4) applies where, before IP completion day, a notification is made to the Comptroller-General of Patents, Designs and Trade Marks in the form set out in Annex -Ia of Regulation (EC) No 469/2009.
(4) That notification is to be treated, on and after IP completion day, as a notification made—
(a)on Patents Form SP5; and
(b)on the same date as the notification made on the form set out in that Annex -Ia.
OJ L152, 16.6.2009, p.1 amended by Regulation (EU) 2019/933, OJ L153, 11.6.2019, p.1.
S.I. 2007/3291, as amended by 2011/2052; there are other amending instruments but none are relevant.