Uploading package leaflets to the Danish Medicines Agency's portal DKMAnet - Package Leaflets

27 September 2016

We have reviewed www.indlaegsseddel.dk and found that the current package leaflets for a number of medicinal products have not been uploaded to DKMAnet - Package Leaflets even though the medicinal products in question have been placed on the market.

We would like to underline that anyone who places a medicinal product on the Danish market must submit the latest approved package leaflet to the Danish Medicines Agency, see section 59(1) of the Danish Medicines Act. The package leaflet must be uploaded to the Danish Medicines Agency’s portal DKMAnet – Package Leaflets.

We have a constant focus on package leaflets to secure a high level of information and safety for users of medicinal products. In July 2013, the guideline to the executive order on labelling etc. of medicinal products (guideline no. 9365 of 3 July 2013) was updated. The update concerns section 11, which provides for an exemption from the requirement for package leaflets for authorised human and veterinary medicinal products. It now appears from the guideline that the exemption from the requirement for package leaflets primarily applies to parenteral medicinal products administered at hospitals, in medical clinics and dental clinics as well as by veterinarians. In addition, it has been specified that the exemption does not apply to parenteral modified-release products and if the medicinal product has suspected adverse reactions that may occur after the patient has left the hospital/clinic/doctor or after the animal is no longer under the supervision of a veterinarian. This type of medicinal products must have a package leaflet that can be handed out to the patient or the animal owner.

Please note that the marketing authorisation holder is responsible for ensuring that the package leaflet is uploaded when the product is marketed, see section 1 of executive order no. 426 of 6 May 2011 on submission of package leaflets to the Danish Medicines Agency. Consequently, we ask all marketing authorisation holders to make sure that package leaflets for marketed medicinal products, which are not exempted under section 11, are uploaded to DKMAnet - Package Leaflets.

Marketing authorisation holders who are in doubt about the necessity of package leaflets can contact:

Lene Havsteen
Regulatory coordinator
Medicines Licensing & Availability
Tel.: +45 44 88 96 18

Minh Phuong Duong
Regulatory coordinator
Medicines Licensing & Availability
Tel.: +45 44 88 97 26

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