S.L. 437.47 чл. 50BRegistration of active substances importers, exporters, distributors and manufacturers.

(1)Importers, exporters, distributors and manufacturers of active substances who are established in Malta shall register their activity with the Veterinary Services.

(2) The registration form shall include, at least, the following information

(a) name or corporate name and permanent address;

(b) the active substances which are to be imported, exported, distributed or manufactured;

(c) particulars regarding the premises and the technical equipment for their activity:

Provided that the persons referred to in sub-regulation

(1) shall submit the registration form to the Veterinary Services at least sixty (60) days prior to the intended commencement of their activity.

(3) The Veterinary Services may, based on a risk assessment, decide to carry out an inspection. If the Veterinary Services notifies the applicant within sixty (60) days of the receipt of the registration form that an inspection will be carried out, the activity shall not begin before the Veterinary Services has notified the applicant that he may commence the activity. If within sixty (60) days of the receipt of the registration form the Licensing Authority has not notified the applicant that an inspection will be carried out, the applicant may commence the activity.

(4) The persons referred to in sub-regulation (1) shall communicate annually to the Veterinary Services an inventory of the changes which have taken place as regards the information provided in the registration form. Any changes that may have an impact on the quality or safety of the active substances that are manufactured, exported, distributed or imported shall be notified immediately.

(5) The Veterinary Services, shall only grant or renew an Authorisation, if the applicant:

(a) specifies the veterinary medicinal products and pharmaceutical forms which are to be manufactured or imported and the place where they are to be manufactured and, or controlled;

(b) has at his disposal, for the manufacture or import of veterinary medicinal products, suitable and sufficient premises, technical equipment and control facilities complying with requirements set by the Veterinary Services;

(c) has at his disposal the services of at least one qualified person within the meaning of regulation 46(1); and

(d) provides all necessary documentation in support of his application.

(6) The Veterinary Services shall issue the Authorisation after verifying the contents of the application but in any case not later than ninety (90) days from receipt of the application.

(7) The time period mentioned in sub-regulation 6 shall be suspended when the Veterinary Services requests additional information from the applicant.