S.L. 458.33 ст. 3Particularsonouter packaging.

The following particulars shall appear on the outer packaging of medicinal products or, where there is no such outer packaging, on the immediate packaging:

(a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name

(INN) shall be included, or, if one does not exist, the common name;

(b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;

(c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;

(d) a list of those excipients known to have a recognised action or effect and which are included in the detailed guidance published by the Commission pursuant to Article 65 of Directive 2001/83/EC as amended by Directive 2004/27/EC. However, if the product is an injectable, or a topical or eye preparation, all excipients must be stated;

(e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;

(f) a special warning that the medicinal product must be stored out of the reach and sight of children;

(g) any special warning that may be necessary for the particular medicinal product;

(h) the expiry date in clear terms (month/year);

(i) special storage precautions, if any;

(j) specific precautions, relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;

(k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;

(l) the number of the marketing authorisation;

(m) the manufacturer’s batch number;

(n) in the case of non-prescription medicinal products, instructions for use;

(o) for medicinal products other than radiopharmaceuticals referred to in paragraph (p), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:

(i) verify the authenticity of the medicinal product, and

(ii) identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with;

(p) medicinal products subject to prescription shall bear the safety features referred to in paragraph (o), unless they have been listed in accordance with the procedure pursuant to Article 54a of Directive 2001/83/EC as amended. Medicinal products not subject to prescription shall not bear the safety features referred to in paragraph (o), unless, by way of exception, they have been listed in accordance with the procedure pursuant to Article 54a of Directive 2001/83/EC as amended, after having been assessed to be at risk of falsification;

(q) the Licensing Authority may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in paragraph (o) to any medicinal product subject to prescription or subject to reimbursement;

(r) the Licensing Authority may, for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology, use the information contained in the repositories system as may be established by the Commission referred to in Article 54a of Directive 2001/83/EC as amended;

(s) the Licensing Authority may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in paragraph (o) to any medicinal product:

Provided that where the outer packaging, or immediate packaging in the absence of an outer packaging, of the medicinal product includes the name of the product, the active substance or substances, pharmaceutical form and strength, in the Roman alphabet, all of the particulars in paragraphs (a) to (n) of this regulation may alternatively be included and accessed by means of the electronic package leaflet:

Provided further that this electronic package leaflet may only be used for medicinal products procured for the national health service.