Article 3Information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals
1.
Operators applying to the competent authority for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals in accordance with Article 94(1)(b) of Regulation (EU) 2016/429 shall include the following information in their applications:
(a)
the name and address of the operator of the germinal product establishment;
(b)
the following details concerning the germinal product establishment:
- (i)
the address;
- (ii)
the name of the centre veterinarian or team veterinarian appointed by the operator in accordance with Article 4(1)(a) of Delegated Regulation (EU) 2020/686;
- (iii)
which of the following types of activities are to be carried out at the germinal product establishment:
the collection, processing and storage of semen,
the collection, processing and storage of embryos,
the collection, processing and storage of oocytes and the production, processing and storage of embryos,
the processing and storage of fresh, chilled or frozen semen, oocytes or embryos,
the storage of fresh, chilled or frozen semen, oocytes or embryos;
- (iv)
a description of how the processing of germinal products is to be carried out, and in the case where all or part of the processing is to be carried out at other germinal product processing establishments, the name and contact details of those germinal product processing establishments;
- (v)
the biosecurity requirements for the operation of the germinal product establishment which shall include at least details of the following:
a structural description and a blueprint of the germinal product establishment,
the standard operating procedures for the collection, production, processing, storage and transport of germinal products, as appropriate for the type of germinal product establishment,
the procedures and instructions from the centre veterinarian or team veterinarian for the implementation of animal health and biosecurity requirements at the germinal product establishment,
a rodent and insect control plan,
information on the format of records kept in accordance with Article 8 of Delegated Regulation (EU) 2020/686,
the procedures for the cleaning and disinfection of the facilities and equipment,
a contingency plan in case of clinical signs of listed diseases or a positive test result for animal pathogens causing listed diseases,
an undertaking to notify the competent authority prior to the implementation of any significant changes relating to the biosecurity requirements for the operation of the germinal product establishment;
(c)
as regards the germinal products:
- (i)
the type of germinal products to be collected, produced, processed or stored, specifying if they are semen, oocytes or embryos;
- (ii)
the species of donor animals, specifying if they are bovine, porcine, ovine, caprine or equine animals;
- (iii)
the conditions of storage of the germinal products, specifying if they are fresh, chilled or frozen.
2.
The application referred to in paragraph 1 shall be in writing, either on paper or in electronic form.