Changes from plenary report to adopted text

AddedThe Agency shall provide advice under this Article free of charge.

AddedArticle 90 Data deriving from a paediatric investigation plan

Added1. Where a marketing authorisation or a variation of a marketing authorisation, is granted in accordance with this Regulation:

Added(a) the results of all clinical studies conducted in compliance with an agreed paediatric investigation plan as referred to in Articles 6(5), point (a), of [revised Directive 2001/83/EC] shall be included in the summary of product characteristics and, if appropriate, in the package leaflet; or

Added(b) any agreed waiver as referred to in Articles 6(5), points (b) and (c) of [revised Directive 2001/83/EC], shall be recorded in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

Added2. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the Commission shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan.

AddedArticle 91 Variation of marketing authorisations on the basis of paediatric studies

Added1. Any clinical study which involves the use in the paediatric population of a medicinal product covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within six months of completion of the studies concerned.

Added2. Paragraph 1 shall apply independent of whether or not the marketing authorisation holder intends to apply for a marketing authorisation of a paediatric indication.

Added3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly, including regarding information on dosage accuracy. [Am. 222]

AddedArticle 92 Paediatric use marketing authorisation

Added1. An application for a paediatric use marketing authorisation shall be submitted in accordance with Articles 5 and 6 and shall be accompanied by the particulars and documents necessary to establish quality, safety and efficacy in the paediatric population, including any specific data needed to support an appropriate formulation, pharmaceutical form, strength, route of administration and eventual administration device for the product, in accordance with an agreed paediatric investigation plan. The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.

Added2. Where a medicinal product is or has been authorised in a Member State or in the Union, data contained in the dossier on that product may, where appropriate, be referred to, in accordance with Article 29 or Article 9 of [revised Directive 2001/83/EC], in an application for a paediatric use marketing authorisation.

Added3. The medicinal product in respect of which a paediatric use marketing authorisation is granted may retain the name of any medicinal product which contains the same active substance and in respect of which the same marketing authorisation holder has been granted authorisation for use in adults.

Added4. Submission of an application for a paediatric use marketing authorisation shall in no way preclude the right to apply for a marketing authorisation for other therapeutic indications.

AddedArticle 93 Rewards for products authorised under the paediatric use marketing authorisation procedure

AddedWhere a paediatric use marketing authorisation referred to in Article 92 is granted and includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the product shall benefit from independent data and marketing protection periods referred to in Articles 80 and 81 of [revised Directive 2001/83/EC].

AddedArticle 94 Paediatric clinical trials

Added1. The EU database created by Article 81 of Regulation (EU) No 536/2014 shall include clinical trials carried out in third countries which are:

Added(a) contained in an agreed paediatric investigation plan;

Added(b) submitted following the provisions of Article 91.

Added2. For the clinical trials mentioned in paragraph 1 which are conducted in third countries, the description of the following elements shall be entered into the EU database prior to the start of the trial by the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan referred to in Article 77, or by the marketing authorisation holder as appropriate:

Added(a) the clinical trial protocol;

Added(b) the investigational medicinal products used;

Added(c) the therapeutic indications covered;

Added(d) details of the trial population.

AddedIrrespective of the outcome of a clinical trial within 6 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database.

AddedIf for justified scientific reasons it is not possible to submit the summary of the result of the trial within 6 months it shall be submitted to the EU database at the latest within twelve months after the trial has ended. The justification for the delay needs also to be submitted in the EU database.

Added3. In consultation with the Commission, Member States and interested parties, the Agency shall draw up guidance on the nature of the information referred to in paragraph 2.

Added4. On the basis of the experience acquired as a result of the operation of this Article, the Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 173(2) to amend the details concerning clinical trials conducted in third countries to be submitted to the EU database and referred to in paragraph 2.

AddedArticle 95 European network

Added1. The Agency shall develop a European network of patient representatives, academics, medicines developers, investigators and centres with expertise in the performance of studies in the paediatric population.

Added2. The objectives of the European network shall be, inter alia, to discuss priorities in the clinical development of medicines for children, in particular in areas of unmet medical need, to coordinate studies relating to paediatric medicinal products, to build up the necessary scientific and administrative competences at European level, and to avoid unnecessary duplication of studies and testing in the paediatric population.

AddedArticle 96 Incentives for research in medicinal products for children

AddedPaediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, paediatric medicinal products.

AddedArticle 97 Fees and Union contribution for paediatric activities

Added1. Where an application for a paediatric use marketing authorisation is submitted in accordance with the procedure laid down in Article 92, the amount of the reduced fees for the examination of the application and the maintenance of the marketing authorisation shall be fixed in accordance with Article 6 of [new fee Regulation].

Added2. Assessments of the following by the Agency shall be free of charge:

Added(a) applications for waivers;

Added(b) applications for deferrals;

Added(c) applications for paediatric investigation plans;

Added(d) compliance with the agreed paediatric investigation plan.

Added3. The Union contribution provided for in Article 154 shall cover the work of the Agency, including the assessment of paediatric investigation plans, scientific advice and any fee waivers provided for in this Chapter, and shall support the Agency's activities under Articles 94 and 95.

AddedArticle 98 Yearly reporting

AddedAt least on an annual basis, the Agency shall make public:

Added(a) a list of the companies and of the products that have benefited from any of the rewards and incentives in this Regulation;

Added(b) the companies that have failed to comply with any of the obligations in this Regulation;

Added(c) the number of paediatric investigation plans agreed in accordance with Article 74;

Added(d) the number of waivers agreed, providing also a summary of their reasons;

Added(e) a list of deferrals agreed;

Added(f) the number of paediatric investigation plans completed;

Added(g) the renewals of the deferrals beyond five years and the detailed reasons provided as mentioned in Article 82;

Added(h) the scientific advice provided for the development of medicinal products addressed to children.

AddedCHAPTER VIII PHARMACOVIGILANCE

AddedArticle 99 Pharmacovigilance

Added1. The obligations of marketing authorisation holders laid down in Articles 99 and 100(1) of [revised Directive 2001/83/EC] shall apply to marketing authorisation holders for medicinal products for human use authorised in accordance with this Regulation.

Added2. The Agency may impose an obligation on a holder of a centralised marketing authorisation to operate a risk management system, as referred to in Article 99(4), point (c) of [revised Directive 2001/83/EC], if there are concerns about the risks affecting the benefit-risk balance of an authorised medicinal product. In that context, the Agency shall also oblige the marketing authorisation holder to submit a risk management plan for the risk-management system that they intend to introduce for the medicinal product concerned.

AddedThe obligation referred to in paragraph 2 shall be duly justified, notified in writing, and shall include the timeframe for submission of the risk-management plan.

Added3. The Agency shall provide the marketing authorisation holder with an opportunity to submit written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within 30 days of receipt of the written notification of the obligation.

AddedOn the basis of the written observations submitted by the marketing authorisation holder, the Agency shall review its opinion.