CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Scope
Article 2
1
This Regulation shall apply to veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market.
2
In addition to the products referred to in paragraph 1 of this Article, Articles 94 and 95 shall also apply to active substances used as starting materials in veterinary medicinal products.
3
In addition to the products referred to in paragraph 1 of this Article, Articles 94, 105, 108, 117, 120, 123 and 134 shall also apply to inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link.
4
By way of derogation from paragraphs 1 and 2 of this Article, only Articles 55, 56, 94, 117, 119, 123, 134 and Section 5 of Chapter IV shall apply to veterinary medicinal products authorised in accordance with Article 5(6).
5
By way of derogation from paragraph 1 of this Article, Articles 5 to 15, 17 to 33, 35 to 54, 57 to 72, 82 to 84, 95, 98, 106, 107, 110, 112 to 116, 128, 130 and 136 shall not apply to homeopathic veterinary medicinal products which are registered in accordance with Article 86.
6
In addition to the products referred to in paragraph 1 of this Article, Chapter VII shall also apply to:
a
substances that have anabolic, anti-infectious, antiparasitic, anti-inflammatory, hormonal, narcotic or psychotropic properties and that may be used in animals;
b
veterinary medicinal products prepared in a pharmacy or by a person permitted to do so under national law, in accordance with a veterinary prescription for an individual animal or a small group of animals (‘magistral formula’);
c
veterinary medicinal products prepared in a pharmacy in accordance with the directions of a pharmacopoeia and intended to be supplied directly to the end-user (‘officinal formula’). Such officinal formula shall be subject to a veterinary prescription when intended for food-producing animals.
7
This Regulation shall not apply to:
a
veterinary medicinal products containing autologous or allogeneic cells or tissues that have not been subjected to an industrial process;
b
veterinary medicinal products based on radio-active isotopes;
c
feed additives as defined in point (a) of Article 2(2) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council ;
d
veterinary medicinal products intended for research and development;
e
medicated feed and intermediate products as defined in points (a) and (b) of Article 3(2) of Regulation (EU) 2019/4.
8
This Regulation shall, except as regards the centralised marketing authorisation procedure, be without prejudice to national provisions on fees.
9
Nothing in this Regulation shall prevent a Member State from maintaining or introducing on its territory any national control measure it deems appropriate regarding narcotic and psychotropic substances.
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).