Section 1 These provisions apply to labelling and package leaflets for human medicinal products. The regulations are a complement to the Medicinal Products Act (2015:315) and the Medicinal Products Regulation (2015:458). The regulations shall not apply to medicinal products manufactured in pharmacies. The expressions and terms used in the Medicinal Products Act (2015:315) have the same meaning in the present provisions.

The following definitions are used in the present provisions for:

Package leaflet: a leaflet containing information for the user which accompanies the medicinal product.

Common name: the international non-proprietary name recommended by the World Health Organisation or, if none exists, the usual common name.

Immediate packaging: the container or other form of packaging immediately in contact with the medicinal product.

Pharmaceutical form: the form of preparation approved by the Swedish Medical Products Agency, which shall be included in the labelling.

The name of the medicinal product: may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.

Strength of the medicinal product: the content of the active substance in the product, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.

Labelling: all text and pictograms on both the immediate and the outer packaging.

Local representative: the company appointed to represent the holder of the marketing authorisation in Sweden

Safety features: the type of unique identifier and safety seal referred to in Chapter 3 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, 

Manufacturer: the company on whose behalf the qualified person decides to release the medicinal product.

Outer packaging: the packaging that contains the immediate packaging.

Section 2 If the marketing authorisation holder does not have a permanent establishment in Sweden, the name of the medicinal product, besides what is regulated in Section 1, may be a common or scientific name accompanied by a trade mark or the name of the local representative.