S.L. 458.64 Art. 12Procurement standards. 11

The managing pharmacist shall ensure that medicinal products offered for online dispensing in accordance with these regulations shall be sourced from a European Union licensed wholesale dealer who sources them from manufacturers or wholesale distributors established in one of the following:

(a) the EU and, or EEA market, provided that the export of critical medicinal products subject to shortages in the originating EU and, or EEA Member State is prohibited.

(b) MRA countries, provided that the medicinal product is licensed in that country forming part of the Mutual Recognition Agreement;

(c) suppliers who have procured products manufactured in compliance with Good Manufacturing Practice standards established by a regulatory authority listed in paragraphs (a) and (b).

(d) operators licensed by regulatory bodies classified under the WHO Listed Authorities Level 4 strictly for products which would be authorised to be placed on their respective markets.

(e) the United Kingdom and any other operator, supplier or country as established by Government notice in the Gazette by the Minister after consultation with the Licensing Authority.