Updating of product information to marketing authorisation holders of authorised medicinal products

19 August 2014

The Danish Medicines Agency reminds marketing authorisation holders of their obligation to update the product information for authorised medicinal products.

The obligation is contained in section 21(2) of the Consolidated Danish Medicines Act no. 506 of 20 April 2013:

"The marketing authorisation holder of a medicinal product for human use shall ensure that the information in the medicinal product's summary of product characteristics, package leaflet and labelling is kept up to date with the current knowledge including the conclusions of the assessments and recommendations published on the European Medicines Agency's medicines web-portal."

As the European Medicines Agency's web-portal is not yet available, the following links may be useful:

PRAC: Agendas, minutes and highlights:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp&mid=WC0b01ac05805a21cf

Press releases from CMDh meetings:

http://www.hma.eu/249.html as well as under pharmacovigilance:
http://www.hma.eu/314.html

Commission decision after PSUR single assessment and referrals with a commission decision:

http://ec.europa.eu/health/documents/community-register/html/refh_others.htm

Information to marketing authorisation holders for generic/hybrid applications where the reference product is a centrally authorised product:

According to article 3 of regulation (EC) No 726/2004 of the European Parliament and the Council, the product information for the above applications must be kept up to date in accordance with the centrally authorised product.

”A generic medicinal product of a reference medicinal product authorised by the Community may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC and Directive 2001/82/EC under the following conditions:

b) the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the Community except for those parts of the summary of product characteristics referring to indications or dosage forms which were still covered by patent law at the time when the generic medicine was marketed”

The obligation does not only apply at the time of authorisation. The product information must be kept up to date in accordance with the reference medicinal product throughout the life cycle of the medicinal product.

As a rule of thumb, unless otherwise provided, the marketing authorisation holder must submit an application for variation in accordance with the applicable rules for generic/hybrid medicinal products no later than two months after publication of the updated product information for the reference medicinal product.

Information about changes to the product information for centrally authorised medicinal products is available at the European Medicines Agency's website:

CHMP: Agendas, minutes and highlights:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000378.jsp&mid=WC0b01ac0580028d2a

as well as on the European Commission's website:

Community Register:

http://ec.europa.eu/health/documents/community-register/index_en.htm

As appears from section 21(2) of the Consolidated Danish Medicines Act, the product information must be kept up to date with the current knowledge. Consequently, the marketing authorisation holder cannot disclaim the obligation to update the product information by referring to new knowledge and/or conclusions, assessments and recommendations published elsewhere than in the links mentioned in this message.