CHAPTER VIMANUFACTURING, IMPORT AND EXPORT

Article 89Application for manufacturing authorisation

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.