S.L. 458.37 Art. 5Registering of activity with the Authority. Cap. 458.

(1) Distributors of active substances who are established in Malta shall register their activity with the Licensing Authority.

(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 distributed;

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

The persons referred to in sub-regulation (1) shall submit the registration form to the Licensing Authority at least sixty days prior to the intended commencement of their activity.

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

(5) Persons referred to in sub-regulation (1) who had commenced their activity before 2 January 2013 shall submit the registration form to the competent authority by 2 March 2013.

(6) Member States shall enter the information provided in accordance with sub-regulation (2) in the European Union database referred to in Article 111(6) of Directive 2001/83/EC as amended.

(7) This regulation shall be without prejudice to articles 101 and 102 of the Medicines Act, hereinafter referred to as "the Act".