1. An application for a manufacturing authorisation shall be submitted to a competent authority in the Member State in which the manufacturing site is located.
2. An application for a manufacturing authorisation shall contain at least the following information:
(a)
veterinary medicinal products which are to be manufactured or imported;
(b)
name or company name and permanent address or registered place of business of the applicant;
(c)
pharmaceutical forms which are to be manufactured or imported;
(d)
details about the manufacturing site where the veterinary medicinal products are to be manufactured or imported;
(e)
a statement to the effect that the applicant fulfils the requirements laid down in Articles 93 and 97.