Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those products have already been marketed with other indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the product on the market taking into account the paediatric indication. A register, coordinated by the Agency, and made publicly available, shall mention these deadlines.
1. In the following cases, the applicant shall detail the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:
(a)
applications for a marketing authorisation that includes a paediatric indication;
(b)
applications to include a paediatric indication in an existing marketing authorisation;
(c)
applications for a paediatric use marketing authorisation.
2. Where there is particular cause for concern, the competent authority shall require, as a condition for granting marketing authorisation, that a risk management system be set up or that specific post-marketing studies be performed and submitted for review. The risk management system shall comprise a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions.
Assessment of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 104(6) of Directive 2001/83/EC and Article 24(3) of Regulation (EC) No 726/2004.
In addition, the competent authority may request submission of additional reports assessing the effectiveness of any risk minimisation system and the results of any such studies performed.
3. In addition to paragraphs 1 and 2, the provisions on pharmacovigilance as laid down in Regulation (EC) No 726/2004 and in Directive 2001/83/EC shall apply to marketing authorisations for medicinal products which include a paediatric indication.
4. In the case of a deferral, the marketing authorisation holder shall submit an annual report to the Agency providing an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral.
The Agency shall inform the competent authority if it is found that the marketing authorisation holder has failed to comply with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral.
5. The Agency shall draw up guidelines relating to the application of this Article.
If a medicinal product is authorised for a paediatric indication and the marketing authorisation holder has benefited from rewards or incentives under Article 36, 37 or 38, and these periods of protection have expired, and if the marketing authorisation holder intends to discontinue placing the medicinal product on the market, the marketing authorisation holder shall transfer the marketing authorisation or allow a third party, which has declared its intention to continue to place the medicinal product in question on the market, to use the pharmaceutical, pre-clinical and clinical documentation contained in the file of the medicinal product on the basis of Article 10c of Directive 2001/83/EC.
The marketing authorisation holder shall inform the Agency of its intention to discontinue the placing on the market of the product no less than six months before the discontinuation. The Agency shall make this fact public.
