TITLE III

MARKETING
CHAPTER 1

Marketing authorization
Article 12
1
For the purposes of obtaining a marketing authorisation in respect of a veterinary medicinal product, otherwise than under the procedure established by Regulation (EC) No 726/2004, an application shall be lodged with the competent authority of the Member State concerned.
In the case of veterinary medicinal products which are intended for one or more food-producing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation. At least six months shall elapse between a valid application for the establishment of maximum residue limits and an application for a marketing authorisation.
However, in the case of veterinary medicinal products referred to in Article 6(3), a marketing authorisation may be applied for without a valid application in accordance with Regulation (EEC) No 2377/90. All the scientific documentation necessary for the demonstration of the quality, safety and efficacy of the veterinary medicinal product, as provided for in paragraph 3, shall be submitted.
2
A marketing authorisation may only be granted to an applicant established in the Community.
3
The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question. The file shall be submitted in accordance with Annex I and shall contain, in particular, the following information:
a
name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and, if different, of the manufacturer or manufacturers involved and of the sites of manufacture;
b
name of veterinary medicinal product;
c
qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its international non-proprietary name (INN) recommended by the WHO, where an INN exists, or its chemical name;
d
description of the method of manufacture;
e
therapeutic indications, contra-indications and adverse reactions;
f
dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life;
g
reasons for any precautionary and safety measures to be taken when storing the veterinary medicinal product, administering it to animals and disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human and animal health and to plants;
h
indication of the withdrawal period in the case of medicinal products intended for food-producing species;
i
description of the testing methods employed by the manufacturer;
j
results of:
- pharmaceutical (physico-chemical, biological or microbiological) tests,
- safety tests and residue tests,
- pre-clinical and clinical trials;
- tests assessing the potential risks posed by the medicinal product for the environment. This impact shall be studied and consideration shall be given on a case-by-case basis to specific provisions seeking to limit it.
k
a detailed description of the pharmacovigilance system and, where appropriate, the risk management system that the applicant will put in place;
l
a summary in accordance with Article 14 of the product characteristics, a mock-up of the immediate packaging and the outer packaging of the veterinary medicinal product, together with the package leaflet, in accordance with Articles 58 to 61;
m
a document showing that the manufacturer is authorised in his own country to produce veterinary medicinal products;
n
copies of any marketing authorisation obtained in another Member State or in a third country for the relevant veterinary medicinal product, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 14 or approved by the competent authority of the Member State in accordance with Article 25 and copies of the package insert proposed, details of any decision to refuse authorisation, whether in the Community or a third country and the reasons for that decision. All this information shall be updated on a regular basis;
o
proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country;
p
in the case of veterinary medicinal products intended for one or more food-producing species and containing one or more pharmacologically active substances not yet included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with the aforementioned Regulation.
The documents and particulars relating to the results of the tests referred to in point (j) of the first subparagraph shall be accompanied by detailed and critical summaries, drawn up as specified in Article 15.
Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.