Article 1, Point (18) · Directive 2011/62/EU

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(1) Article 1 is amended as follows:
(2) in Article 2, paragraph 3 is replaced by the following: ‘3…
(3) in Article 8(3), the following point is inserted:
(4) in Article 40, paragraph 4 is replaced by the following: ‘…
(5) in Article 46, point (f) is replaced by the following:
(6) the following Article is inserted: ‘Article 46b1.Member St…
(7) in Article 47, the third and fourth paragraphs are replace…
(8) the following Article is inserted: ‘Article 47a 1. The saf…
(9) in Article 51(1), the following subparagraph is inserted b…
(10) the following Articles are inserted: ‘Article 52a1.Importe…
(11) in Article 54, the following point is added:
(12) the following Article is inserted: ‘Article 54a1.Medicinal…
(13) in Article 57, the fourth indent of the first paragraph is…
(14) the heading of title VII is replaced by the following: ‘Wh…
(15) in Article 76, paragraph 3 is replaced by the following: ‘…
(16) Article 77 is amended as follows:
(17) Article 80 is amended as follows:
(18) in the first paragraph of Article 82, the following indent…
(19) the following Articles are inserted: ‘Article 85aIn the ca…
(20) the following Title is inserted before Title VIII: ‘TITLE…
(21) Article 111 is amended as follows:
(22) the following Articles are inserted: ‘Article 111aThe Comm…
(23) in Article 116, the following paragraph is added: ‘The sec…
(24) the following Article is inserted: ‘Article 117a1.Member S…
(25) the following Articles are inserted: ‘Article 118a1.The Me…
(26) in Article 121a(1), the words ‘Article 22b’ are replaced b…
(27) in Article 121b(1), the words ‘Article 22b’ are replaced b…

(18)in the first paragraph of Article 82, the following indent is added:

—batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54;’;

Directive 2011/62/EU

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