S.L. 458.64 ст. 13Quality assurance and traceability.

(1) The licence holder shall establish and maintain a quality management system to ensure that medicinal products are procured solely in accordance with the provisions of regulation 12. Furthermore, the licence holder shall ensure that each medicinal product dispensed complies with the safety, quality, and efficacy standards specified in the authorisation of the product in the country of origin, without exception:

Provided that, for the purpose of this regulation, "authorisation" means an authorisation equivalent to, or substantially similar to, a marketing authorisation as defined in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency.

(2) The licence holder shall ensure that there is full traceability of all medicinal products purchased, stored and dispensed in accordance with these regulations, which shall, at a minimum include records and documentation in relation to:

(a) prescriptions, including consumer’s details, country of prescription, prescribing healthcare professional’s information, and prescription dates:

Provided that a scanned or electronic copy of the prescription as provided by the consumer through the website shall suffice;

(b) product name, active ingredient, dosage form, dose, pack size, batch and lot numbers, supplier, expiration date, and storage conditions;

(c) purchasing, storage, and dispensing of a medicinal product, including date of dispensing and the registration number of the dispensing pharmacist;

(d) any other information, as may from time to time, be established by the Licensing Authority in accordance with regulation 20(3).