PART 13Packaging and leaflets
CHAPTER 1
Enforcement and offences
Offence relating to packaging and package leaflets: holder of authorisation etc268
1
This regulation applies to the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, a medicinal product to which the authorisation, certificate or registration relates.
2
A person to whom this regulation applies is guilty of an offence if—
a
a package or package leaflet relating to the product does not comply with the applicable requirements of this Part or Article 28 or 32 of the Paediatric Regulation; or
b
the product is not accompanied by a package leaflet when one is required by virtue of this Part.