S.L. 458.40 Art. 7Duties of parallel importer.

It shall be the duty of a parallel importer to -

(a) ensure that there is a clear audit trail from the authorised distributor or manufacturer in the source country;

(b) submit to the Licensing Authority a declaration that the supplier is going to keep him informed of any pharmacovigilance issues;

(c) provide a written declaration stating that the marketing authorisation holder of the original product marketed in Malta has been notified about the product being put on sale in Malta, one month prior to submitting the application to the Licensing Authority;

(d) submit, in the case of repackaging of a medicinal product, a sample of the proposed repackaged product to the marketing authorisation holder of the original product marketed in Malta;

(e) submit to the Licensing Authority a copy of the declaration sent to the marketing authorisation holder referred to in paragraph (c) and, in the case of re-packaging of a medicinal product, a specimen of the proposed re-packaged product together with the application for a parallel import licence;

(f) ensure that the parallel import licence number assigned by the Licensing Authority is present on the outer packaging of the medicinal products.