TITLE II U.K.OBLIGATIONS OF OPERATORS

CHAPTER II U.K.Placing on the market

Section 3 U.K.Derived products regulated by certain other [F1 retained EU law]

Article 33 U.K.Placing on the market

Operators may place on the market the following derived products:

(a)

cosmetic products as defined in [F2 Article 2(1)(a) of Regulation 1223/2009/EC];

(b)

active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC;

(c)

medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC;

(d)

in vitro diagnostic medical devices as defined in Article 1(2)(b) of Directive 98/79/EC;

(e)

veterinary medicinal products as defined in Article 1(2) of Directive 2001/82/EC;

(f)

medicinal products as defined in Article 1(2) of Directive 2001/83/EC.

Textual Amendments

F2 Words in Art. 33(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 12(17)

Article 34 U.K.Manufacture

1. The import, collection and movement of animal by-products and derived products destined for establishments or plants for the manufacture of the derived products referred to in Article 33 and the manufacture of those derived products shall be carried out in accordance with [F3 the following:]

[F4 (a) Regulation 1223/2009/EC in the case of cosmetic products;

(b) the Medical Devices Regulations 2002 in the case of active implantable medical devices, medical devices and in vitro diagnostic medical devices;

(c) the Veterinary Medicines Regulations 2013 in the case of veterinary medicinal products;

(d) the Human Medicines Regulations 2012 in the case of medicinal products.]

Unused material from such establishments or plants shall be disposed of in accordance with that legislation.

2. However, this Regulation shall apply where the F5 ... legislation referred to in [F6 paragraph 1(a) to (d)] does not provide for conditions controlling potential risks to public and animal health in accordance with the objectives of this Regulation.

Textual Amendments

F3 Words in Art. 34(1) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 12(18)(a)

F4 Words in Art. 34(1) inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 12(18)(b)

F5 Word in Art. 34(2) omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 12(18)(c)(i)

F6 Words in Art. 34(2) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 12(18)(c)(ii)

Textual Amendments

F1 Words in Regulation substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), reg. 12(2)