CHAPTER II

MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
Section 7

Examination of applications and basis for granting marketing authorisations

Decisions refusing marketing authorisations
Article 37
1
Decisions refusing marketing authorisations referred to in Article 5(1) shall be taken on the basis of the documents prepared in accordance with Article 33(1) and shall be duly justified and include the reasons for refusal.
2
A marketing authorisation shall be refused if any of the following conditions are met:
a
the application does not comply with this Chapter;
b
the benefit-risk balance of the veterinary medicinal product is negative;
c
the applicant has not provided sufficient information on the quality, safety or efficacy of the veterinary medicinal product;
d
the veterinary medicinal product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;
e
the proposed withdrawal period is not long enough to ensure food safety or is insufficiently substantiated;
f
the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;
g
the applicant has not provided sufficient proof of efficacy as regards the target species;
h
the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;
i
risks to public or animal health or to the environment are not sufficiently addressed; or
j
the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, and the veterinary medicinal product is intended to be used in food-producing animals, unless it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health.
3
A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans as provided for in paragraph 5.
4
The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Regulation by establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials.
5
The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
6
The Commission shall, when adopting the acts referred to in paragraphs 4 and 5, take into account the scientific advice of the Agency, the EFSA and other relevant Union agencies.